Latest news with #FDAwarning
Yahoo
6 days ago
- Health
- Yahoo
NFL Explains Why They Banned Smelling Salts From Games
NFL Explains Why They Banned Smelling Salts From Games originally appeared on The Spun. The NFL has reportedly done away with a staple of its locker rooms and sidelines for decades. On Tuesday, star 49ers tight end George Kittle crashed the NFL Network's training camp set in Santa Clara to break the news that the league just put a ban on smelling salts and ammonia packets. Kittle, a nine-year NFL veteran, claims he used them every drive: "I honestly came here to air a grievance," the All-Pro began. "Our team got a memo today that [said] smelling salts and ammonia packets were made illegal in the NFL. I've been distraught all day. I considered retirement. We have to figure out a middle ground. Somebody help me out." After doing some digging, insider Mike Garafolo got a hold of the memo that was sent out to all 32 clubs about the new rule and apparently it has to do with a warning issued by the FDA last year. "In 2024, the FDA issued a warning to companies that produce commercially available ammonia inhalants (AIs), as well as to consumers about the purchase and use of AIs, regarding the lack of evidence supporting the safety or efficacy of AIs marketed for improving mental alertness or boosting energy," the memo read. "The FDA noted potential negative effects from AI use," it continued. "AIs also have the potential to mask certain neurologic signs and symptoms, including some potential signs of concussion. As a result, the NFL Head, Neck, and Spine Committee recommended prohibiting the use of AIs for any purpose during play in the NFL." The league noted that the new ban goes into effect immediately for the 2025 season which includes, "ammonia capsules, inhalers, ammonia in a cup or any form of 'smelling salts,'" and also applies to all team and league personnel "through the entirety of all NFL games [pregame and halftime]." As upset as some players are, it doesn't sound like the league is going to budge based on the wording. We'll see what types of alternatives they're able to come up with to give them the jolt they'll be missing this Explains Why They Banned Smelling Salts From Games first appeared on The Spun on Aug 5, 2025 This story was originally reported by The Spun on Aug 5, 2025, where it first appeared.
Daily Mail
04-08-2025
- Health
- Daily Mail
FDA escalates butter recall of 65,000lbs over undeclared deadly allergen
The FDA has escalated its warning over a major butter recall that was triggered by a labeling issue. Bunge North America recalled 64,800lbs of its Non-Hydrogenated European Style Butter Blend last month after investigators found the label did not include milk in the ingredient list. But now the FDA has upgraded the alert to Class II, used when officials fear temporary or medically reversible health effects. Up to 50million Americans are lactose intolerant, estimates suggest, while 6.1million have an allergy to milk. A milk allergy can result in hives, a rash, vomiting, diarrhea, abdominal pain, trouble breathing or a life-threatening reaction called anaphylaxis. The butters were distributed to restaurants and bakeries across the US and the Dominican Republic. They were not sold in grocery stores. The recall included 1,800 cases of 36-count 1lbs butter blocks. A total of 64,800 blocks of the butter have been recalled. The FDA said butters in the recall had a product code found on their packaging that reads: 5064036503. It has not been revealed whether there are any reports of adverse reactions as a result of consuming the butter. Businesses that received the butter were warned over the labeling issue via email, letter, telephone call or a visit. Estimates suggest about 30 to 50million Americans suffer from lactose intolerance, leaving them unable to eat foods such as butter. The condition is caused by the small intestine no longer making the enzyme lactase, which is used to break down the sugar lactose found in milk-containing foods. It can cause stomach upset and bloating but it is not a life threatening allergy. It more commonly affects African or Hispanic Americans and people who have taken antibiotics or chemotherapy drugs. Doctors say the condition usually can't be reversed, and people are advised to manage it by following a low-lactose diet. This is done by limiting consumption of any lactose-containing foods, such as cakes, cookie dough and milk chocolate. People with a milk allergy, however, can suffer more severe symptoms within minutes of consuming cow's milk. It is caused by the immune system attacking a protein found in the milk. Those who suffer from the reaction can be treated with antihistamines or epinephrine to reduce the reaction.
Reuters
25-07-2025
- Health
- Reuters
US FDA says J&J's unit issues correction related to surgical stapler
July 25 (Reuters) - The U.S. drug regulator said on Friday a unit of Johnson & Johnson (JNJ.N), opens new tab issued a correction for certain lots of a part related to its surgical stapler and classified the action as "most serious". The issue is related to the unit Ethicon Endo-Surgery's device, 'Endopath Echelon Vascular White Reload for Advanced Placement Tip', which tends to inadvertently lockout during surgical procedures, the Food and Drug Administration said, opens new tab on its website. "There has been one reported death and one injury related to this issue," the agency added. The part in question is a single-use cartridge that surgeons load into a stapler to cut and close blood vessels or tissue during an operation. This helps control bleeding and close wounds quickly. However, the FDA said the device may sometimes appear to work but fail to cut or staple tissue during surgery, and could lead to life-threatening bleeding, surgical delays, or death. A J&J spokesperson said in an email to Reuters that it notified its affected customers through a correction letter in April, and added that it was a voluntary correction, not a product removal. Ethicon has advised healthcare facilities to review affected batches and ensure operating room personnel are familiar with the device's instructions for use and lockout mitigation protocols, the FDA said.
Reuters
25-07-2025
- Health
- Reuters
US FDA says J&J's Ethicon issues correction related to surgical stapler
July 25 (Reuters) - The U.S. drug regulator said on Friday Ethicon Endo-Surgery, a unit of Johnson & Johnson (JNJ.N), opens new tab, issued a correction for certain lots of a part related to its surgical stapler and classified the action as "most serious". The issue is related to the device 'Endopath Echelon Vascular White Reload for Advanced Placement Tip' which tends to inadvertently lockout during surgical procedures, the Food and Drug Administration said, opens new tab on its website. "There has been one reported death and one injury related to this issue," the agency added. The part in question is a single-use cartridge that surgeons load into a stapler to cut and close blood vessels or tissue during an operation. This helps control bleeding and close wounds quickly. However, the FDA said the device may sometimes appear to work but fail to cut or staple tissue during surgery, and could lead to life-threatening bleeding, surgical delays, or death. Ethicon notified its affected customers through a correction letter in April, but the company's action is not a full product recall, the agency said. The FDA said Ethicon has advised healthcare facilities to review affected batches and ensure operating room personnel are familiar with the device's instructions for use and lockout mitigation protocols. Johnson & Johnson did not immediately respond to a Reuters request for comment.
CNN
24-07-2025
- Health
- CNN
Black box warning on menopause hormone therapies should be removed, experts say
All menopause treatments containing the hormone estrogen are mandated by the US Food and Drug Administration to carry a black box warning on the label, stating that the treatments could increase the risk of strokes, blood clots, dementia and breast cancer. Now, that advisory may be going away. Last week, a panel of experts convened by the FDA urged the federal agency to remove the cautionary language on at least some forms of hormone therapy. I wanted to understand more about why these warnings were first added and the arguments for and against removing them now. What are hormone therapies used for, and what are the different forms of treatment? What is the history behind adding black box warnings, and why are some experts pushing to remove them? What should women know about managing menopause symptoms? I turned to CNN wellness expert Dr. Leana Wen to answer these questions. Wen is an emergency physician and adjunct associate professor at George Washington University. She previously was Baltimore's health commissioner. CNN: When does menopause occur, and what kinds of symptoms do women experience during menopause? Dr. Leana Wen: Menopause is the stage in a woman's life when her menstrual periods permanently stop. It marks the end of fertility and is accompanied by a decline in reproductive hormones such as estrogen and progesterone. In the US, most women begin the menopause transition between ages 45 and 55, and the average age is 52. The definition of menopause is a full year without having a period. Except in situations where menopause is induced by surgery (for example, removal of ovaries) or specific medical conditions, this period is generally preceded by a stage called perimenopause, when women may have irregular periods and start experiencing menopause symptoms. Symptoms associated with menopause can include hot flashes and night sweats. Hot flashes are sudden sensations of heat, skin flushing and sweating that can significantly disrupt daily activities. About one-third of women have more than 10 hot flashes per day. When they occur at night, they can disrupt sleep and increase fatigue and irritability during the day. Menopausal declines in estrogen also may cause vaginal dryness, decreased libido and discomfort during intercourse. Some women experience other symptoms such as mood changes, anxiety, difficulty concentrating, dry skin and weight gain. Moreover, while this is not a symptom of menopause per se, the risk of developing chronic conditions such as cardiovascular disease and osteoporosis increases significantly after menopause. This rise in risk is thought to be linked to the decline in estrogen levels, as estrogen has a protective effect on maintaining healthy blood vessels and supporting bone density. CNN: What are hormone therapies used for? What are the different forms of treatment? Wen: Hormone therapies are prescription drugs that are used to treat menopause symptoms. They replace the hormones that decline during menopause. It's important to differentiate between two types of hormone therapy. The first is systemic therapy in which hormones are given in a way that is absorbed into the bloodstream. That could be through taking pills or using patches, sprays or gels. Systemic therapy is used to treat symptoms that affect the entire body, such as flashes and night sweats. The second type is low-dose vaginal estrogen therapy. This is a cream or suppository administered into the vagina to treat vaginal dryness and reduce tissue thinning. Unlike systemic therapy, this type of therapy works locally; its purpose is not to raise hormone levels throughout the body. CNN: What is the history behind adding black box warnings, and why are some experts pushing to remove them? Wen: For decades, hormone therapy was considered the standard of care for menopause-related symptoms. Then, in the early 2000s, a landmark study called the Women's Health Initiative was published that suggested hormone therapy increased the risk of breast cancer, heart disease and stroke. It concluded that the benefits of this therapy did not outweigh these risks, leading to the FDA adding the black box warning in 2003. Many researchers have since examined the methodological problems of the study. One significant issue was that the average age of participants was 63. The women studied were mostly postmenopausal, so the question answered was regarding the risks and benefits to postmenopausal women, not menopausal women. Last year, scientists — including some of the original researchers of the Women's Health Initiative — published an updated analysis in the journal JAMA. They concluded that, in fact, hormone treatment with a combination of estrogen and progesterone is safe and effective for treating hot flashes and other systemic symptoms if started before age 60 or within 10 years of starting menopause and if the woman does not have specific contraindications — for instance, an estrogen-sensitive breast cancer. This updated analysis is one reason cited by many advocates to remove the warning. Another major reason is that the black box warning is currently on all types of hormone treatments, including vaginal therapies that deliver far lower doses and do not have the systemic effect of, say, an estrogen-containing pill. Advocates argue that putting all forms of hormone therapy under the same warning misrepresents risk and makes it harder for women to receive relief from troublesome symptoms. Women are still able to access the therapies despite the warning, but some may be more hesitant to use them after seeing the warnings. CNN: What are other arguments for and against this change? Wen: In his opening argument, FDA Commissioner Dr. Marty Makary remarked that systemic hormone therapy, when started within 10 years of the onset of menopause, can actually reduce cardiovascular disease. This finding is suggested by some recent studies, which also show a benefit for bone health. Not everyone agrees that hormone therapy should be taken for preventive purposes. There is also some controversy about process; specifically, the panelists who spoke at last week's FDA meeting were all selected by Makary and all favored hormone therapy. Some have said they would appreciate more balance by hearing from experts who have more nuanced views. In addition, there was no presentation by internal FDA scientists, who, in the past, have given their own analysis during these types of meetings. CNN: While the FDA is considering changing the warning label, what is your advice for women about managing menopause symptoms? Wen: The most important thing is that women who are experiencing significant symptoms during menopause don't need to suffer in silence. Effective treatments exist. Women should speak with their physicians about lifestyle measures that can help as well as hormonal and nonhormonal prescription therapies. They should also speak with their providers about preventive care to improve heart health and prevent bone loss. Those who want additional resources should look to the Menopause Society, which also has a searchable database of clinicians who are certified menopause practitioners and trained to guide women through this transition.
