Legal Bodybuilding SARMS: Why More Pro Lifters in 2025 Trust CrazyBulk's Safe Alternatives to Gain Muscle, Increase Strength and Cutting
The New Era of Bodybuilding: From Risky Steroid Compounds to Legal SARMs
The bodybuilding industry is undergoing a seismic shift in priorities. For decades, people wanting muscle, strength, and razor-sharp definition often meant making tough choices between performance and health.
But as science advances and regulations tighten, the next generation of pro and amateur lifters is demanding more: they want real results without risking their long-term well-being.
At the epicenter of this evolution is the rise of legal SARMs alternatives - a new class of supplements that promise the muscle-building and fat-burning power of traditional anabolic agents, but with a focus on safety, legal compliance, and natural ingredients. And when it comes to legal SARMs, one name stands at the forefront: CrazyBulk.CrazyBulk has firmly established itself as the market leading SARMs company in the USA and worldwide, earning a reputation for excellence with its safe, legal, and natural alternatives to the most sought-after selective androgen receptor modulators.
View SARMS bulking stack for rapid muscle growth
Weight lifters, Bodybuilders and professional athletes trust CrazyBulk for their cutting-edge muscle supplements inspired by RAD 140 (Testolone), Ostarine 2866, Ligadrol LGD 4033, and Ibutamoren MK 677.
Unlike conventional SARMs, CrazyBulk's formulas deliver the muscle-building, fat-cutting, and performance-boosting benefits of these powerhouse compounds—without the legal risks, side effects, or need for a prescription.
With rigorous quality standards, transparent ingredient sourcing, and a proven track record of global customer satisfaction, CrazyBulk continues to lead the industry as the go-to provider for anyone looking for safe, effective SARMs for muscle growth, fat loss, and total body transformation.
What Are SARMs and Why Do Bodybuilders Want Them?
SARMs, or Selective Androgen Receptor Modulators, were originally developed as a way to harness the muscle-building benefits of anabolic steroids while minimizing undesirable side effects.
Unlike classic steroids, SARMs target specific androgen receptors in muscle and bone tissue, theoretically resulting in enhanced muscle growth, strength, and fat loss with fewer risks.
However, unregulated SARMs have been plagued by health concerns, legal restrictions, and purity issues. As a result, the demand for safe, legal, and effective alternatives has never been higher—especially among elite athletes who refuse to compromise their careers or health.
CrazyBulk: The Trusted Name in Legal SARMs Alternatives
CrazyBulk has long been recognized as a leader in natural, legal performance supplements. In 2025, the brand has solidified its reputation by launching a comprehensive line of legal SARMs alternatives - formulas designed to help bodybuilders and athletes achieve their goals without the downsides of banned or synthetic substances.
With over 500,000 bottles sold and a global customer base, CrazyBulk's SARMs alternatives have rapidly become the go-to choice for professional lifters, physique competitors, and fitness enthusiasts who want results that last.
Why Pro Lifters Are Switching to Legal SARMs Alternatives
1. Regulatory Compliance and Peace of Mind
For competitive athletes, the risk of testing positive for banned substances is career-ending. CrazyBulk's SARMs alternatives are 100% legal and designed to comply with international anti-doping regulations.
Each formula is crafted from natural ingredients, thoroughly tested for purity, and guaranteed free of synthetic SARMs, hormones, or illegal compounds.
2. Science-Driven Results Without Compromise
The muscle-building supplements market has seen its share of hype and empty promises. CrazyBulk's legal SARMs alternatives are different. Built on a foundation of peer-reviewed research and real-world user feedback, these products are formulated to:
Build lean muscle mass
Increase strength and power
Accelerate fat loss
Support natural testosterone production
Enhance recovery and endurance
3. No Needles, No Side Effects, No Prescription
Traditional anabolic steroids and unregulated SARMs often require injections, post-cycle therapy, and come with a laundry list of potential side effects—from hormonal imbalances to liver strain.
CrazyBulk SARMs alternatives are oral supplements with zero known side effects, no prescription required, and no need for complicated cycles.
Inside the Formula: How CrazyBulk's SARMs Alternatives Deliver Next-Level Results
A Lineup Tailored for Every Phase: Bulking, Cutting, and Strength
CrazyBulk legal SARMs alternatives are engineered for every stage of the bodybuilding journey:TESTOL 140 – RAD 140 (Testolone)If you're looking to pack on serious muscle and power, TESTOL 140 is a must have. A powerful RAD 140 (Testolone) SARM, this natural muscle builder is all about helping your body boost its own testosterone—the key hormone behind rapid muscle growth, strength, and fast recovery.
TESTOL 140 makes it easier for athletes and gym-goers to smash through their plateaus and see real, noticeable gains. People using it often talk about lifting heavier, working out harder, and bouncing back quicker after intense sessions. Best of all, you get all these benefits without the risks that come with synthetic anabolic agents.
IBUTA 677 – MK 677 (Ibutamoren)
Ever wish you could tap into your body's natural muscle-building potential? IBUTA 677 is modeled after MK 677 (Ibutamoren) and works by supporting your natural human growth hormone (HGH) levels. The result? Fuller muscles, more visible veins, and muscle gains that come quicker than you might expect.
What really sets IBUTA 677 apart is how it helps you get better, deeper sleep—so your muscles repair and grow even while you rest. For anyone serious about bulking up and staying strong, this supplement helps you build muscle and strength in a way that feels natural and sustainable.
LIGAN 4033 – LGD 4033 (Ligandrol)
When your goal is to outlast everyone else in the gym, LIGAN 4033 is for endurance. A legal version LGD 4033 (Ligandrol) SARM, this formula is all about boosting endurance and muscle performance. It works by increasing blood flow and getting more oxygen to your muscles, which means you experience bigger pumps and less fatigue during tough workouts.
People who use LIGAN 4033 say they can go harder for longer, crank out more reps, and recover faster between sets. If you want to maximize your results during a bulking phase and push your body to new limits, this is the supplement to have in your corner.
C-DINE 501516 – GW 501516 (Cardarine)
If getting lean and showing off real muscle definition is your goal, C-DINE 501516 is made for you. Based on GW 501516 (Cardarine), this supplement is all about firing up your body's fat-burning engine.
It helps increase fat oxidation and revs up your metabolism, so you burn more calories—even when you're not working out.
What sets C-DINE 501516 apart is how it goes after stubborn fat, especially in those hard-to-lose areas, while making sure you don't lose your hard-earned muscle. It's a top pick for competitive bodybuilders and anyone looking to cut down for summer, a photoshoot, or just to feel their best in lean shape.
STENA 9009 – SR 9009 (Stenabolic)
When you need to keep your energy high and your workouts intense, STENA 9009 is the SARM of choice. A safe alternative to SR 9009 (Stenabolic), this formula is perfect for boosting endurance, stamina, and blood flow, especially during tough cutting cycles.
Think of it as your secret weapon for powering through cardio sessions or demanding high-intensity intervals. STENA 9009 helps your body burn more fat for fuel while making sure you stay motivated and energetic, not run-down. It's ideal for anyone who wants to stay sharp, focused, and athletic while getting shredded.
OSTA 2866 – MK 2866 (Ostarine)
If you want to get lean without sacrificing any muscle, OSTA 2866—the legal version of (Ostarine)—is the answer. This supplement is legendary for helping you hold onto muscle size and strength, even when you're cutting calories hard. It's a real muscle-saver, protecting your gains so you don't lose all your hard work when you shed body fat.
Plus, OSTA 2866 is known to support your joints and help with recovery, which really matters during intense training or dieting phases. For anyone chasing that defined, athletic look but wanting to stay strong and injury-free, OSTA 2866 is a must-have.
For All-Out Performance: Ultimate StacksCutting SARMS Stack includes legal versions of MK677, Cardarine, Stenabolic SR9009 and Ligandrol.View SARMS Cutting Stack price and availability
For those who want maximum results, CrazyBulk offers bulking, cutting, and ultimate stacks—carefully curated bundles that combine the benefits of multiple SARMs alternatives for synergistic muscle growth, strength, and fat loss.
The Science Behind the Supplements: 100% Natural, Athlete-Tested, and Proven
Ingredient Integrity: Nature's Most Powerful Performance Boosters
What sets CrazyBulk's SARMs alternatives apart is their commitment to legal ingredients with proven efficacy. Each product is free from synthetic SARMs, steroids, or hormones. Instead, formulas are built on:
Herbal extracts known for boosting testosterone and growth hormone
Adaptogens for improved endurance and stress resilience
Thermogenic agents for enhanced fat burning
Amino acids and micronutrients to promote muscle repair and recovery
Selective Androgen Receptor Modulators Quality Control and Transparency
Every batch of CrazyBulk's SARMs alternatives is subjected to rigorous testing for potency and purity. All products are manufactured in GMP-certified facilities and come with transparent labeling—so you know exactly what you're putting into your body.
From the Pros: Real Results, Real Transformations
Trusted by Elite Bodybuilders and Everyday Lifters Alike
CrazyBulk's SARMs alternatives aren't just for the stage. They're trusted by:
IFBB pros looking for a legal edge
Powerlifters seeking sustainable strength
CrossFit athletes demanding stamina and muscle preservation
Busy professionals who want to maximize gym results without legal or health risks
Success Stories and Before/After Transformations
With hundreds of thousands of bottles sold and a global community of satisfied users, CrazyBulk's social media is filled with before-and-after photos, testimonials, and real-world success stories. Many pro lifters report:
Noticeable muscle gain within 4–6 weeks
Improved strength and performance
Faster recovery between intense sessions
Leaner, more defined physiques during cutting cycles
Zero side effects or hormonal crashes
The End of the 'Old School Anabolic Steroids' Era: Why Today's Bodybuilders Want Legal SARMs
Changing Priorities: From Size at Any Cost to Sustainable Performance
In the past, bodybuilding was dominated by a 'bigger is better' mentality—often at the expense of long-term health. But in 2025, priorities are shifting. More professional athletes now value:
Sustainable gains over short-lived bulks
Functional strength and stamina for real-world performance
Drug-tested compliance for career longevity
Low-risk, accessible supplementation
CrazyBulk's SARMs alternatives are perfectly matched to this new era, delivering performance nutrition that works for both competition and everyday life.
Stacking Strategies: How Pro Lifters Cycle Legal SARMs Alternatives for Best Results
The Power of Synergy: Stacks That Amplify Results
One of the most effective ways to maximize results with CrazyBulk's SARMs alternatives is through stacking—using complementary products together to target multiple aspects of muscle growth, fat loss, and performance.
Bulking Stack (Building Muscle Size)
TESTOL 140 + IBUTA 677 + LIGAN 4033This powerful trio supports muscle hypertrophy, strength gains, and hormonal balance for all-out growth phases.
Cutting Stack (Muscle Preservation and Fat Loss)
C-DINE 501516 + STENA 9009 + OSTA 2866Designed to preserve hard-earned muscle while shedding fat, this stack is ideal for pre-contest prep or summer shredding.
Ultimate SARMs Stack (Bulking, Cutting and Strength Gains)
Combine all six SARMs alternatives for a comprehensive cycle that maximizes muscle, strength, and leanness.
Cycle Lengths and Best Practices
Most pro lifters follow a 6–8 week cycle with a 1–2 week break between stacks. During this time, users are encouraged to:
Maintain a high-protein, nutrient-dense diet
Prioritize sleep and recovery
Stay hydrated
Track progress and adjust dosage as needed
CrazyBulk provides detailed stack guides, dosage instructions, and cycle planners with every purchase, making it easy to optimize your approach.
Safety First: How CrazyBulk Sets a New Standard for Legal SARMs Alternatives
Zero Compromises on Health or Legality
Unlike underground SARMs or black-market steroids, CrazyBulk's alternatives are:
100% legal in all countries
Free from banned substances
Suitable for both men and women
Non-habit forming
No prescription required
This makes them a safe bet for anyone—pro or amateur—seeking elite results without regulatory or health headaches.
No Hidden Ingredients, No Side Effects
Every formula is free from synthetics, fillers, and harsh chemicals. Users report zero known side effects, no hormonal crashes, and no need for complicated post-cycle therapy.
Next-Level Convenience: Global Shipping, Money-Back Guarantee, and Support
Fast, free shipping on orders over $100 to more than 100 countries
Secure checkout and all major credit cards accepted
Buy 2, Get 1 Free and stack savings on all major bundles
60-day money-back guarantee for risk-free trials
Dedicated support and product guidance from the CrazyBulk team
Who Should Use Legal SARMs Alternatives?
Pro Athletes and Competitors
For those in drug-tested sports, legal SARMs alternatives are the gold standard for muscle, strength, and definition—without risking disqualification.
Lifters Over 30
Aging athletes face declining testosterone and slower recovery. SARMS like TESTOL 140 and IBUTA 677 help bridge the gap, supporting muscle retention, stamina, and energy.
Women in Strength Sports
CrazyBulk's SARMs alternatives are suitable for women seeking lean muscle, strength, and cutting support—without masculinizing side effects.
Fitness Enthusiasts and Beginners
Beginners and recreational lifters can safely use these products to fast-track results, boost confidence, and break through plateaus.
How to Get Started: Your Roadmap to Bigger, Stronger, and Leaner in 2025
Step 1: Define Your Goal
Are you looking to bulk up, shred fat, or maximize all-around performance? CrazyBulk's online product finder quiz and customer support can guide you to the right stack.
Step 2: Choose Your Stack or Individual Product
Bulking? Try the SARMs Bulking Stack.
Cutting? Opt for the SARMs Cutting Stack.
Want it all? Go for the Ultimate SARMs Stack.
Step 3: Follow the Plan
Take your supplements as directed.
Stick to your training and nutrition plan.
Monitor your progress and adjust as needed.
Step 4: Enjoy Real Results—No Compromises
Join the ranks of pro lifters and fitness enthusiasts worldwide who are achieving record gains, faster recovery, and superior body composition—all while staying safe and legal.
Frequently Asked Questions (FAQ)
1. Are CrazyBulk's dietary supplements safe for long-term use?Yes, CrazyBulk's dietary supplements are made from natural ingredients and rigorously tested for safety. They are designed to avoid common issues like liver toxicity and are free from synthetic selective androgen receptor modulators (SARMs) or androgenic anabolic steroids.
2. Can CrazyBulk products help increase muscle mass without the risks of traditional SARMs like Rad 140?Absolutely. CrazyBulk's formulas are crafted to stimulate muscle growth and increase muscle mass, offering a natural alternative to compounds like Rad 140, but without concerns like testosterone suppression or liver toxicity.
3. Are CrazyBulk's supplements legal and FDA approved?CrazyBulk's dietary supplements are legal and available without a prescription. However, as with most bodybuilding supplements, the FDA warns these products are not intended to diagnose, treat, cure, or prevent any disease.
4. Will these supplements show up on drug tests?No, CrazyBulk's products do not contain banned selective androgen receptor modulators or androgenic anabolic steroids, making them suitable for drug-tested athletes focused on performance enhancement.
5. How do these supplements support body fat reduction and fat oxidation?CrazyBulk's legal alternatives are designed to promote fat oxidation and body fat reduction while helping to preserve or increase muscle mass, which is essential for those aiming for a leaner physique.
6. Is there a risk of testosterone suppression with CrazyBulk's legal alternatives?No, the natural ingredients in CrazyBulk's supplements are formulated to avoid the risk of testosterone suppression, a common concern with traditional SARMs like ostarine mk 2866 or Rad 140.
7. Do I need to stack or cycle these dietary supplements for best results?While each supplement is effective on its own, stacking recommended products can increase bulking and cutting goals such as muscle growth, body fat reduction, and fat oxidation. Most users follow 6–8 week cycles with breaks.
8. Are there any known risks of liver toxicity associated with CrazyBulk SARMS?Unlike traditional androgenic anabolic steroids and some selective androgen receptor modulators, CrazyBulk's legal alternatives are designed to avoid liver toxicity, ensuring safer long-term use.
9. How quickly can I expect to see improvements in muscle mass and performance?Many users report noticeable increases in muscle mass and improved fat oxidation within 4–6 weeks, especially when combined with a consistent training regimen and healthy dietary habits.
10. Are CrazyBulk's products suitable alternatives to ostarine mk 2866 or Rad 140 for lean muscle growth?Yes, CrazyBulk's legal supplements are positioned as safe, effective alternatives to compounds like ostarine mk 2866 and Rad 140. They support performance enhancement and muscle growth without the regulatory or health risks associated with traditional SARMs.
Final Summary: The Future of Bodybuilding Is Legal, Safe, and Effective
The days of high-risk shortcuts and questionable compounds are coming to an end. In 2025, elite athletes and fitness enthusiasts have a better choice—one that delivers the muscle, strength, and definition they crave, without the dangers of traditional SARMs or steroids.
CrazyBulk legal SARMs alternatives are leading this revolution, offering real results that are safe, sustainable, and fully compliant with sports regulations. Whether you're a pro chasing your next title, a lifter seeking your personal best, or anyone committed to long-term fitness, it's time to experience the CrazyBulk advantage.
The era of legal muscle building SARMs is here. Are you ready to build, cut, and conquer—without compromise?
Disclaimer: The information provided in this article is for educational purposes only and does not constitute medical advice. Always consult a healthcare professional before starting any supplement regimen. Individual results may vary.
Media Contact:Steve Niddich, Head of Product InnovationCrazyBulk244 Madison Avenue, New York City, NY 10016-2817Email: support@crazybulk.comPhone: +1 888-708-6394Website: https://crazybulk.comAttachment
CrazyBulk
CONTACT: Media Contact: Steve Niddich, Head of Product Innovation CrazyBulk 244 Madison Avenue, New York City, NY 10016-2817 Email: support@crazybulk.com Phone: +1 888-708-6394 Website: https://crazybulk.com

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GAAP and non-GAAP SG&A expenses decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. GAAP and non-GAAP gross margin on net product sales decreased in the second quarter of 2025, compared to the second quarter of 2024, partly due to ongoing investments to support the Company's manufacturing operations and higher inventory write-offs and reserves in the second quarter of 2025 compared to the second quarter of other income (expense), net included the recognition of net unrealized gains on equity securities of $250 million in the second quarter of 2025, compared to $393 million in the second quarter of 2024. In the second quarter of 2025, the Company's GAAP effective tax rate (ETR) was 8.4%, compared to 12.0% in the second quarter of 2024. The GAAP ETR decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to the net change in uncertain tax positions, partly offset by lower tax benefits from less stock option exercises. During the second quarter of 2025, the release of liabilities for uncertain tax positions recognized upon the effective settlement of an IRS audit reduced the Company's GAAP ETR by 3.9%. In the second quarter of 2025, the non-GAAP ETR was 8.3%, compared to 10.8% in the second quarter of 2024. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press the second quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $1.070 billion, as Treasury Stock. As of June 30, 2025, $2.814 billion remained available for share repurchases under the Company's share repurchase programs. In July 2025, the Company's board of directors declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on September 3, 2025 to shareholders of record as of August 18, Company's full year 2025 financial guidance consists of the following components: 2025 Guidance Prior Updated GAAP R&D $5.560–$5.795 billion $5.660–$5.790 billion Non-GAAP R&D(a) $5.000–$5.200 billion $5.100–$5.200 billion GAAP SG&A $2.910–$3.095 billion $2.810–$2.940 billion Non-GAAP SG&A(a) $2.550–$2.700 billion $2.450–$2.550 billion GAAP gross margin on net product sales 83%–84% Approximately 83% Non-GAAP gross margin on net product sales(a) 86%–87% Approximately 86% COCM* $1.000–$1.150 billion $1.000–$1.050 billion Capital expenditures* $850–$950 million $880–$950 million GAAP effective tax rate 9%–11% 11%–13% Non-GAAP effective tax rate(a) 11%–13% Unchanged * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below: Projected Range ($ in millions) Low High GAAP R&D $ 5,660 $ 5,790 Stock-based compensation expense 560 590 Non-GAAP R&D $ 5,100 $ 5,200 GAAP SG&A $ 2,810 $ 2,940 Stock-based compensation expense 360 390 Non-GAAP SG&A $ 2,450 $ 2,550 GAAP gross margin on net product sales 83% 83% Intangible asset amortization expense 2% 2% Stock-based compensation expense 1% 1% Non-GAAP gross margin on net product sales 86% 86% GAAP ETR 11% 13% Income tax effect of GAAP to non-GAAP reconciling items <1% <1% Non-GAAP ETR 11% 13% (a) This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other operating (income) expense, net, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flow, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, the non-GAAP measures presented are intended to provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b) The Company's 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (c) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (d) Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2025 financial and operating results on Friday, August 1, 2025, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, competing drugs and product candidates that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") (including biosimilar versions of Regeneron's Products); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), Ordspono™ (odronextamab), Lynozyfic™ (linvoseltamab), other clinical programs discussed in this press release, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2024 and its Form 10-Q for the quarterly period ended June 30, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Non-GAAP Financial Measures This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. Contact Information: Ryan Crowe Christina Chan Investor Relations Corporate Affairs 914-847-8790 914-847-8827 TABLE 1 REGENERON PHARMACEUTICALS, CONSOLIDATED BALANCE SHEETS (Unaudited) June 30, December 31, 2025 2024 Assets: Cash and marketable securities $ 17,527.8 $ 17,912.6 Accounts receivable, net 5,610.0 6,211.9 Inventories 3,205.6 3,087.3 Property, plant, and equipment, net 4,840.7 4,599.7 Intangible assets, net 1,351.7 1,148.6 Deferred tax assets 3,572.2 3,314.1 Other assets 2,111.2 1,485.2 Total assets $ 38,219.2 $ 37,759.4 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $ 4,887.0 $ 4,888.0 Finance lease liabilities 720.0 720.0 Deferred revenue 688.2 813.4 Long-term debt 1,985.1 1,984.4 Stockholders' equity 29,938.9 29,353.6 Total liabilities and stockholders' equity $ 38,219.2 $ 37,759.4 TABLE 2 REGENERON PHARMACEUTICALS, CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues: Net product sales $ 1,631.0 $ 1,918.6 $ 3,046.6 $ 3,679.9 Collaboration revenue 1,860.7 1,524.0 3,391.9 2,790.8 Other revenue 183.9 104.5 265.8 221.4 3,675.6 3,547.1 6,704.3 6,692.1 Expenses: Research and development 1,421.7 1,200.0 2,749.1 2,448.4 Acquired in-process research and development 10.0 23.9 22.3 31.0 Selling, general, and administrative 634.2 758.8 1,267.2 1,447.8 Cost of goods sold 275.6 257.8 541.1 498.2 Cost of collaboration and contract manufacturing 254.6 222.4 453.4 415.8 Other operating expense (income), net — 14.6 — 29.9 2,596.1 2,477.5 5,033.1 4,871.1 Income from operations 1,079.5 1,069.6 1,671.2 1,821.0 Other income (expense): Other income (expense), net 442.8 573.3 764.8 538.7 Interest expense (3.6 ) (14.8 ) (12.3 ) (30.9 ) 439.2 558.5 752.5 507.8 Income before income taxes 1,518.7 1,628.1 2,423.7 2,328.8 Income tax expense 127.1 195.8 223.4 174.5 Net income $ 1,391.6 $ 1,432.3 $ 2,200.3 $ 2,154.3 Net income per share - basic $ 13.24 $ 13.25 $ 20.78 $ 19.95 Net income per share - diluted $ 12.81 $ 12.41 $ 20.02 $ 18.68 Weighted average shares outstanding - basic 105.1 108.1 105.9 108.0 Weighted average shares outstanding - diluted 108.6 115.4 109.9 115.3 TABLE 3 REGENERON PHARMACEUTICALS, OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP R&D $ 1,421.7 $ 1,200.0 $ 2,749.1 $ 2,448.4 Stock-based compensation expense 139.0 122.4 280.0 245.4 Acquisition and integration costs — 5.3 — 9.1 Non-GAAP R&D $ 1,282.7 $ 1,072.3 $ 2,469.1 $ 2,193.9 GAAP SG&A $ 634.2 $ 758.8 $ 1,267.2 $ 1,447.8 Stock-based compensation expense 91.8 82.6 187.0 168.8 Acquisition and integration costs — 9.7 0.8 28.5 Non-GAAP SG&A $ 542.4 $ 666.5 $ 1,079.4 $ 1,250.5 GAAP COGS $ 275.6 $ 257.8 $ 541.1 $ 498.2 Stock-based compensation expense 20.9 18.2 40.4 39.1 Acquisition and integration costs — 0.8 — 1.2 Intangible asset amortization expense 32.4 25.1 61.1 48.3 Non-GAAP COGS $ 222.3 $ 213.7 $ 439.6 $ 409.6 GAAP other operating expense (income), net $ — $ 14.6 $ — $ 29.9 Change in fair value of contingent consideration — 14.6 — 29.9 Non-GAAP other operating expense (income), net $ — $ — $ — $ — GAAP other income (expense), net $ 439.2 $ 558.5 $ 752.5 $ 507.8 Gains on investments, net (250.0 ) (392.6 ) (389.9 ) (196.5 ) Non-GAAP other income (expense), net $ 189.2 $ 165.9 $ 362.6 $ 311.3 GAAP net income $ 1,391.6 $ 1,432.3 $ 2,200.3 $ 2,154.3 Total of GAAP to non-GAAP reconciling items above 34.1 (113.9 ) 179.4 373.8 Income tax effect of GAAP to non-GAAP reconciling items (2.1 ) 32.8 (27.7 ) (61.0 ) Non-GAAP net income $ 1,423.6 $ 1,351.2 $ 2,352.0 $ 2,467.1 Non-GAAP net income per share - basic $ 13.55 $ 12.50 $ 22.21 $ 22.84 Non-GAAP net income per share - diluted $ 12.89 $ 11.56 $ 21.06 $ 21.09 Shares used in calculating: Non-GAAP net income per share - basic 105.1 108.1 105.9 108.0 Non-GAAP net income per share - diluted 110.4 116.9 111.7 117.0 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Effective tax rate reconciliation: GAAP ETR 8.4 % 12.0 % 9.2 % 7.5 % Income tax effect of GAAP to non-GAAP reconciling items (0.1 %) (1.2 %) 0.4 % 1.2 % Non-GAAP ETR 8.3 % 10.8 % 9.6 % 8.7 % Gross margin on net product sales reconciliation: GAAP gross margin on net product sales 83 % 87 % 82 % 86 % Intangible asset amortization expense 2 % 1 % 2 % 2 % Stock-based compensation expense 1 % 1 % 2 % 1 % Non-GAAP gross margin on net product sales 86 % 89 % 86 % 89 % Six Months Ended June 30, 2025 2024 Free cash flow reconciliation: Net cash provided by operating activities $ 2,189.5 $ 1,866.5 Capital expenditures (448.3 ) (314.4 ) Free cash flow $ 1,741.2 $ 1,552.1 TABLE 4 REGENERON PHARMACEUTICALS, REVENUE (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $ 1,282.1 $ 988.3 $ 2,300.2 $ 1,792.3 Reimbursement for manufacturing of commercial supplies 161.5 157.3 326.6 263.1 Total Sanofi collaboration revenue 1,443.6 1,145.6 2,626.8 2,055.4 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 383.4 353.0 700.7 686.9 Reimbursement for manufacturing of commercial supplies 31.6 22.1 58.2 44.2 Total Bayer collaboration revenue 415.0 375.1 758.9 731.1 Other collaboration revenue 2.1 3.3 6.2 4.3 Total collaboration revenue $ 1,860.7 $ 1,524.0 $ 3,391.9 $ 2,790.8 TABLE 5 REGENERON PHARMACEUTICALS, PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) Three Months Ended June 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA HD(a) $ 393.2 $ 241.7 $ 634.9 $ 304.2 $ 59.1 $ 363.3 75 % EYLEA(a) $ 754.3 $ 736.0 $ 1,490.3 $ 1,230.5 $ 848.7 $ 2,079.2 (28 %) Total EYLEA HD and EYLEA $ 1,147.5 $ 977.7 $ 2,125.2 $ 1,534.7 $ 907.8 $ 2,442.5 (13 %) Dupixent(b) $ 3,205.0 $ 1,139.6 $ 4,344.6 $ 2,610.2 $ 946.2 $ 3,556.4 22 % Libtayo(c) $ 247.8 $ 128.7 $ 376.5 $ 182.4 $ 115.0 $ 297.4 27 % Praluent(d) $ 65.8 $ 156.2 $ 222.0 $ 56.1 $ 135.8 $ 191.9 16 % Kevzara(b) $ 95.7 $ 56.5 $ 152.2 $ 65.1 $ 44.6 $ 109.7 39 % Other products(e) $ 42.1 $ 30.0 $ 72.1 $ 30.9 $ 21.9 $ 52.8 37 % Six Months Ended June 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA HD(a) $ 700.0 $ 388.1 $ 1,088.1 $ 504.2 $ 74.3 $ 578.5 88 % EYLEA(a) $ 1,490.3 $ 1,447.4 $ 2,937.7 $ 2,432.1 $ 1,682.9 $ 4,115.0 (29 %) Total EYLEA HD and EYLEA $ 2,190.3 $ 1,835.5 $ 4,025.8 $ 2,936.3 $ 1,757.2 $ 4,693.5 (14 %) Dupixent(b) $ 5,834.4 $ 2,175.8 $ 8,010.2 $ 4,828.2 $ 1,805.0 $ 6,633.2 21 % Libtayo(c) $ 440.3 $ 221.3 $ 661.6 $ 341.6 $ 219.7 $ 561.3 18 % Praluent(d) $ 122.6 $ 292.7 $ 415.3 $ 126.1 $ 267.1 $ 393.2 6 % Kevzara(b) $ 168.5 $ 100.1 $ 268.6 $ 115.1 $ 88.7 $ 203.8 32 % Other products(e) $ 73.2 $ 53.5 $ 126.7 $ 56.2 $ 40.8 $ 97.0 31 % Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below. (a) The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue. (b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue (c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales (d) The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue. (e) Included in this line item are products which are sold by the Company and others. Refer to "Second Quarter 2025 Financial Results" section above for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST®, which are recorded by Kiniksa.


Medscape
an hour ago
- Medscape
Nutrition Assistance Programs Combat Cognitive Decline
Nutrition assistance programs do more than fighting hunger. They also may help guard against age-related cognitive decline. Researchers found that people who participated in the US Supplemental Nutrition Assistance Program (SNAP) had slower cognitive decline over 10 years than peers who did not participate in the program. 'The chief policy implication of our study is that nutrition assistance programs like SNAP are not just anti-hunger tools — they are also public health tools that may help protect cognitive function and promote healthy aging,' lead author Linlin Da, MPH, PhD candidate, University of Georgia College of Public Health, Athens, Georgia, told Medscape Medical News . The study was presented on July 30 at the Alzheimer's Association International Conference (AAIC) 2025. Healthy Food, Healthy Brain Using the nationally representative Health and Retirement Study, researchers analyzed a racially and ethnically representative group of people aged 50 years or older. They compared 1131 individuals (mean age, 63 years) who were enrolled in SNAP in 2010 to 1216 individuals (mean age, 66 years) who were eligible for SNAP but did not participate in the program. 'Our study focused on SNAP — a real-world, policy-level intervention — rather than just individual food choices,' Da noted. As part of the study, memory and executive function were assessed every 2 years between 2010 and 2020 via telephone or web-based interviews. Individuals with an initial cognition summary score indicating cognitive impairment or dementia were excluded from the analysis. The researchers found that SNAP participants had a 0.10% slower decline in overall cognitive function ( P < .001 ), or 2-3 additional years of cognitive health over the 10-year period. 'For someone starting at a healthy cognitive score, this slower decline could delay reaching the threshold for mild cognitive impairment by nearly a decade,' Da noted in a conference statement. SNAP participants also had a slower decline in memory ( P < .001 ) and executive function ( P = .004 ) than peers not enrolled in SNAP. 'Our study is one of the first long-term, nationally representative studies to show that participation in a federal nutrition assistance program like SNAP is associated with slower cognitive decline in older adults,' Da told Medscape Medical News . Da said there are several biological and social mechanisms that may explain how SNAP participation slows cognitive decline, including improved nutrition. 'SNAP increases access to nutrient-dense foods that support brain health — such as fruits, vegetables, whole grains, and lean proteins. Better nutrition is linked to reduced inflammation, improved vascular health, and preservation of cognitive function over time,' Da explained. Reduced food insecurity and stress is another possibility. 'Chronic food insecurity is a significant source of psychological stress, which can negatively impact brain function. SNAP helps alleviate financial and emotional strain, leading to lower levels of chronic stress and potentially reducing harmful stress-related effects on memory and executive function,' Da said. 'We hope healthcare providers will see that potentially delaying cognitive impairment is another reason to help their patients-in-need secure access to food assistance,' co-author Suhang Song, PhD, assistant professor, Department of Health Policy and Management, University of Georgia College of Public Health, added in a conference statement. Equity Gaps While all racial and ethnic groups benefitted from SNAP participation, the protective effects on cognitive decline were smaller among non-Hispanic Black and Hispanic older adults compared with non-Hispanic White participants. There were 'racial and ethnic disparities in the cognitive benefits of SNAP, which points to important equity gaps in how nutrition policies may impact different populations,' Da said. 'We guess, even with SNAP, living in food deserts or areas with fewer healthy food options may limit the quality of nutrition people can access. This can especially affect Black and Hispanic communities, where structural barriers to healthy eating persist,' Da said. Commenting on this study for Medscape Medical News , Courtney Kloske, PhD, director of Scientific Engagement for the Alzheimer's Association, said it 'highlights the importance of nutritious foods and the impact that can have on the brain.' Maria Carrillo, PhD, chief science officer and medical affairs lead, Alzheimer's Association, noted that food insecurity can negatively affect cognitive function, and this is one of the first long-term studies to show that food assistance programs can positively impact cognition. 'Simple, everyday actions can make a difference in brain health and may even lower the risk of Alzheimer's disease and dementia. The Alzheimer's Association is committed to helping all people build these habits into their daily lives, including eating right, one of our 10 Healthy Habits for Your Brain,' Carrillo said in a statement.


CNN
an hour ago
- CNN
Common allergy medication's risks outweigh its usefulness, experts say
Prescription drugsFacebookTweetLink Follow Dr. Anna Wolfson says she sees dangerous misuse of the allergy medication diphenhydramine in her clinic every day. 'If someone has an allergic reaction to a food, people will say, 'Don't worry, I have diphenhydramine in my purse,' and I would say, 'Really, epinephrine is the first-line treatment for food allergies,'' said Wolfson, an allergist at Massachusetts General Hospital. Diphenhydramine can be harmful if people take it after having an allergic reaction to food, she said, because the drug – best known by the brand name Benadryl – makes them drowsy and can cause them to miss signs that their symptoms are getting worse. 'It's time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,' she said. 'I've had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.' Wolfson isn't alone in preferring alternatives. In a review published in February, allergy experts from Johns Hopkins University and the University of California, San Diego called for the removal of diphenhydramine from over-the-counter and prescription markets in the United States, saying it's outdated, dangerous and eclipsed by safer alternatives. A first-generation antihistamine approved in 1946, diphenhydramine is widely used for allergies, sleep aid and cold symptoms. It's a common over-the-counter medication in the US, with usage rising in the summer months as people use it to treat itching from bug bites or poison ivy, as well as sneezing and runny nose caused by grass and pollen allergies, according to the American Pharmacists Association. Despite its longstanding presence in American homes, the authors of the new review say it poses disproportionate risks, especially for children and older adults, than newer antihistamines. 'Patients should trial alternatives agents like loratadine, which is Claritin, or cetirizine, which is Zyrtec, or fexofenadine, which is Allegra,' to alleviate allergy symptoms, Dr. James Clark of the Department of Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine, the lead author of the paper, told CNN. The Consumer Healthcare Products Association, which represents the OTC medicine industry, says that common side effects associated with products containing diphenhydramine are disclosed on the label. However, it notes, 'these products are not intended for long-term use.' 'When used as directed, these medicines provide well-established therapeutic benefits for common health ailments like allergies, the common cold, motion sickness, minor skin irritations, and occasional sleeplessness,' the group said in a statement on behalf of Benadryl's maker, Kenvue. 'Like all medicines, responsible use is essential, and consumers should always follow directions and warnings on the Drug Facts labels and consult healthcare providers if they have questions.' Antihistamines work by blocking receptors called H1, part of the body's system for responding to allergens, which trigger symptoms like sneezing, itching and a runny nose. But older drugs like diphenhydramine don't just block the allergy-related receptors, they can also affect other parts of the brain. Diphenhydramine often causes sedation, cognitive impairment, and in some cases, dangerous cardiac effects, the authors wrote. In older adults, the drug can stay in the body for up to 18 hours, resulting in lingering sleepiness, disorientation and increasing risk of falling. The review also highlighted a possible link between long-term diphenhydramine use and dementia. In children, the risks can be even more pronounced. The review's authors cite cases of accidental overdose; paradoxical reactions such as agitation, extreme sedation and coma; and even death, particularly with pediatric formulations, because of accidental ingestions. The medication was linked to several child hospitalizations and fatalities during the viral 'Benadryl Challenge' on TikTok. Dr. Manuela Murray, director of general pediatrics and urgent care at the University of Texas Medical Branch, says diphenhydramine 'should not be used lightly.' 'It should always be used under the guidance of a Medical Professional, and it is only indicated to treat allergic reactions and motion sickness,' Murray wrote in an email. The medication is often misused and 'doesn't offer a benefit for treatment of cold symptoms, and it is not a safe sleep aid medication,' she said. In fact, it can have the opposite effects in children, leading to hyperactivity. Dr. Alyssa Kuban, a pediatrician and associate medical director at Texas Children's Pediatrics, also said that she finds diphenhydramine overused for symptoms it does not directly treat and that there are safer alternatives. 'I see some families use diphenhydramine when the child has a cold or upper respiratory infection, thinking it will help with the congestion and help them to sleep better at night,' she said. 'This is not effective for cold symptoms, nor is it very safe.' She recommends over-the-counter cetirizine to treat children with hives, seasonal allergies or an itchy rash. Cetirizine is also longer-lasting and not as sedating as diphenhydramine, she says. Murray agrees that loratadine and cetirizine are safer for children over 6 months, and saline drops and suctioning are better alternatives for infants. Diphenhydramine appears in over 300 OTC formulations, often blended into combination products for coughs, colds and flu. The authors of the review say that, like products with pseudoephedrine, diphenhydramine should at minimum be moved behind the counter, allowing pharmacists to guide patients toward second-generation alternatives. The American Pharmacists Association says patients should use caution with combination cough and cold products that contain diphenhydramine. Pharmacists may recommend alternative medications for older adults who have a history of being cognitively affected by certain medications, the group says, and it 'encourages patients and parents/caregivers to ask their pharmacist for the most appropriate treatment recommendation for their symptoms' with the least amount of side effects. The review authors also emphasize that there is no strong clinical data that may suggest that diphenhydramine works better than other options. Although it may reduce symptoms like sneezing and itching, it has minimal effect on nasal congestion and doesn't outperform second-generation drugs in randomized trials. Newer options, such as oral cetirizine, offer 24-hour coverage with fewer adverse events. However, in the US, the medication remains a staple. According to the review, more than 1.5 million prescriptions are still written annually, not counting untracked OTC purchases. 'In the past, it has been a useful medication that has helped millions of patients; however, its current therapeutic ratio is matched or exceeded by second-generation antihistamines, especially due to their markedly reduced adverse reactions. It is time to say a final goodbye to diphenhydramine, a public health hazard,' the authors wrote.