logo
A drug carrying the FDA's most serious warning recalled by a Florida company

A drug carrying the FDA's most serious warning recalled by a Florida company

Miami Herald24-07-2025
A pharmaceutical company based in Naples with research and development division based in Coral Springs recalled a drug for failing an in-house testing of medication degradation.
Lupin Pharmaceuticals' Clomipramine Hydrochloride capsules are used 'for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD),' according to the National Library of Medicine. The 2,724 recalled 100-count bottles of 25 mg capsules come from lot No. M300464 with an expiration date of June 2025.
Lupin issued no press release for the June 27 recall.
READ MORE: The role fake Viagra played in a 70-year-old Miami doctor losing his license
Clomipramine also counts as an antidepressant and carries an FDA 'Black Box Warning' or 'Boxed Warning' on the packaging that begins:
'Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.'
If you experience a medical problem because of this or any other drug, first notify a medical professional. Then tell the FDA via the MedWatch program, either online or by calling 800-332-1088.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information
Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information

Business Upturn

time29 minutes ago

  • Business Upturn

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information

By GlobeNewswire Published on August 7, 2025, 10:18 IST Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV. The FDA decision follows the announcement in July by the European Medicines Agency (EMA)1 which recommended the lifting of temporary restrictions in elderly people after the conclusion of a thorough review of IXCHIQ® by its safety committee (PRAC). The PI has been updated to reflect reports of Serious Adverse Events, primarily among elderly individuals with multiple underlying health conditions, following a mass vaccination campaign in La Réunion in response to a severe chikungunya outbreak. The FDA noted that for most U.S. travelers the risk of exposure to CHIKV is low and therefore, the product is not advisable for most of them. IXCHIQ® should be given when there is a significant risk of chikungunya infection and only after careful consideration of the benefits and risks. Healthcare professionals are reminded that IXCHIQ® is contraindicated in individuals with weakened immune systems due to disease or immunosuppressive treatments, as stated in IXCHIQ®'s product label in the U.S., Europe and other territories. Furthermore, the product's Warnings and Precaution section has been expanded to reflect the SAE profile observed, especially in people above 65 years of age and older with one or more chronic medical conditions. Ongoing FDA reviews are progressing regarding potential extension of IXCHIQ®'s label to adolescents and inclusion of additional persistence data. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years2. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas3. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas4 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.5 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099 [email protected] Joshua Drumm, Global Investor RelationsM +001 917 815 4520 [email protected] Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted | European Medicines Agency (EMA) 2 3 4 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). . Last accessed 01 Aug 2023. 5 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_08_07_FDA_UPDATE_IXCHIQ_PR_EN_FINAL_v3 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.

John Cena, 48, says getting this cosmetic procedure 'completely changed' his life
John Cena, 48, says getting this cosmetic procedure 'completely changed' his life

Business Insider

time2 hours ago

  • Business Insider

John Cena, 48, says getting this cosmetic procedure 'completely changed' his life

John Cena, 48, wrestled with hair loss for years, but this cosmetic procedure gave him his confidence back. In an interview with People published on Wednesday, Cena spoke about retiring from the WWE and the realities of aging, including his experience with hair loss. "As I was trying to hide my hair loss, the audience was bringing it to light," he told People. "I saw their signs that said 'The bald John Cena.'" The 17-time WWE world champion said the public scrutiny around his appearance "pushed him" to find ways to deal with hair loss. "I now have a routine: red-light therapy, minoxidil, vitamins, shampoo, conditioner — and I also got a hair transplant last November," Cena said. "I hate the fact that if there wasn't so much shame around it, I'd have gotten it done 10 years ago." The wrestler said he thought he was "alone" in his struggle, but eventually realized how common hair loss was among men. The procedure was simple, Cena said: "They don't do anything except move your hair, one by one, from one area to another." He added that he isn't embarrassed to talk about his hair transplant experience. "If somebody's going to sweat me for that, I don't think there's any shame in that," Cena said. "It completely changed the course of my life." As he looks beyond wrestling, he believes a fuller hairline might help him land a broader range of roles. "A different hairstyle can identify a part that can get me more work, do the thing I love to do," he added. A representative for Cena did not immediately respond to a request for comment sent by Business Insider outside regular hours. Male pattern baldness, or androgenetic alopecia, accounts for over 95% of hair loss in men, per data from the American Hair Loss Association, a nonprofit organization. Around 25% of men with male pattern baldness start losing hair before age 21. There are two FDA-approved medications for male pattern baldness, while other treatment options include laser therapy, platelet-rich plasma, and hair transplants. In recent years, Turkey has made a name for itself as the go-to destination for hair transplant surgery. Around one million people traveled to Turkey for hair transplants in 2022, the head of the Turkish Health Tourism Association told local news agency Anadolu. There's also been a trend of white-collar men in the US spending thousands on plastic surgery, fillers, and other self-care routines to look good, especially at work. Data from the 2023 American Society of Plastic Surgeons procedural statistics report showed that men accounted for 6% of cosmetic procedures overall. In 2023, facelifts among men rose by 17%, nose reshaping increased by 10%, and eyelid surgery increased by 9% compared to the previous year.

Becton, Dickinson and Company Submits Application to the FDA for a New, At-Home HPV Test
Becton, Dickinson and Company Submits Application to the FDA for a New, At-Home HPV Test

Yahoo

time5 hours ago

  • Yahoo

Becton, Dickinson and Company Submits Application to the FDA for a New, At-Home HPV Test

Becton, Dickinson and Company (NYSE:BDX) is one of the . On July 31, Becton, Dickinson and Company (NYSE:BDX) announced that it submitted an application to the U.S. FDA for a new, at-home HPV test. The new HPV test focuses on patients to self-collect a sample at their home using a swab, the size of a Q-tip, simplifying lab processing. According to BD, this method also reports more high-risk strains of HPV compared to other tests on the market today. A person wearing a state-of-the-art medical device for nerve conduction tests. 'We envision a world where women are empowered with access and a choice for their HPV screening, whether it be in a routine visit at the doctor's office or the comfort and privacy of their own home via a self-collected sample. Cervical cancer and the loss of more than 4,000 women per year to this devastating disease is preventable, and we believe at-home testing is an important leap forward to our goal of eliminating this type of cancer,' said Nikos Pavlidis, president of BD Diagnostic Solutions. BD's new HPV test will include a state-of-the-art self-collection swab technology that also offers convenient mailing from home to the lab, supporting broader participation in cervical cancer screening programs. The self-collected swab requires no manual sample preparation by clinical laboratory technologists. This process will allow them to focus on higher-value work. Becton, Dickinson and Company (NYSE:BDX) is a global medical technology company that focuses on the development, manufacturing, and sale of various medical supplies, devices, diagnostic products, and laboratory equipment. While we acknowledge the potential of BDX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store