All articles tagged with #fda warning
A USA TODAY investigation shows vaginal estrogen—a safe, inexpensive treatment to prevent recurrent urinary tract infections in menopausal women—can substantially lower hospitalizations, sepsis, and death, yet its use remains around 10% among Medicare patients due to decades of FDA warnings, training gaps, and cost barriers, contributing to preventable suffering and deaths like Roselin Shankland’s.
Autistic children as young as 18 months are receiving unapproved umbilical cord stem cell infusions at US clinics, promoted with support from Robert F. Kennedy Jr. and autism advocates, despite no proven benefit and FDA warnings that such treatments are likely illegal outside clinical trials; procedures can cost up to $20,000 per session and may require repeated top-ups, while a Duke University trial found little objective improvement and safety risks persist. The article also discusses Mexico‑based trials and marketing tactics by clinics exploiting regulatory gaps and misinterpretations of the Right‑to‑Try law.
FDA warns that Genova Yellowfin Tuna cans from a February recall could be contaminated with botulinum; some suspect cans were inadvertently shipped by a third-party distributor to six chains across nine states (Meijer in IL/IN/KY/MI/OH/WI, Giant Foods in MD/VA, and Safeway/Albertsons/Vons/Pavilions in CA). Affected products include four 5-ounce cans in Olive Oil (UPC 4800073265; codes S84N D2L or S84N D3L; best-by Jan 21/24, 2028) and five-ounce cans in Extra Virgin Olive Oil with Sea Salt (UPC 4800013275S88N; best-by Jan 17, 2028; code D1M1/17/2028). Discard or return for refunds and seek medical care if unwell; questions go to Tri-Union Seafoods.
The FDA has issued warnings to major retailers including Target and Walmart for failing to remove recalled ByHeart infant formula linked to at least 51 cases of infant botulism, emphasizing the importance of proper recall procedures to prevent further health risks.
The FDA has expanded a recall of 16 cinnamon brands due to elevated lead levels, which can cause health and neurological issues, especially in children. Consumers are advised to check their cinnamon products before holiday baking, stop using affected items, and dispose of them. No illnesses have been reported yet, but lead exposure can cause symptoms like abdominal pain, nausea, and behavioral changes.
Parents in North Texas are concerned following an FDA warning about a possible link between Tylenol (acetaminophen) and autism, prompting calls for further research and caution during pregnancy, amid mixed reactions from advocacy groups and officials.
A cat in San Francisco was euthanized after contracting bird flu from contaminated raw cat food containing H5N1, marking the first such case since spring. The FDA confirmed the presence of the virus in the food and the cat, with genetic analysis linking the cases to a common source. Despite multiple human bird flu cases in the U.S., there is little public oversight or tracking of animal cases now, amid controversial opinions on disease management from officials like Robert F. Kennedy Jr.
Novo Nordisk has filed over 130 lawsuits across 40 states to combat illegal marketing and sale of unsafe, non-FDA-approved compounded semaglutide products, which pose serious health risks due to illicit ingredients and misleading claims. The company is actively working to protect patients through legal action, education campaigns, and advocating for stricter enforcement against counterfeit and unapproved drugs.
Sarepta Therapeutics reported a third patient death due to acute liver failure after receiving its gene therapy, adding to recent fatalities of two teenage boys, which has led to stock decline and increased regulatory scrutiny, including a warning label from the FDA.
Sarepta Therapeutics announced a major restructuring, cutting over a third of its workforce and maintaining its gene therapy for Duchenne muscular dystrophy despite patient deaths and FDA warnings about liver failure risks, with the company focusing on safety measures and cost savings.
The FDA has issued a warning about tianeptine, a substance sold as a dietary supplement but known as 'gas station heroin' due to its opioid-like effects and potential for overdose and dependence, despite not being approved in the US. It is often sold online and in shops, with reports of addiction, withdrawal, and overdose cases, raising concerns about its unregulated use and detection challenges.
The FDA has expanded warnings on Pfizer and Moderna COVID-19 vaccines about a rare risk of myocarditis, especially in young males aged 12-24, with a rate of 8 cases per million doses in individuals aged 6 months to 64 years, amid ongoing debates over vaccine safety and policy.
The article discusses the dangers of tianeptine, often sold as 'gas station heroin,' a substance unapproved by the FDA that can be addictive and cause serious health risks. Despite being illegal to sell as a supplement in the U.S., it is widely available in various products, leading to a rise in poison control calls and health emergencies. Some states have enacted laws to restrict its use, which has helped reduce related incidents.
Health experts warn about 'gas station heroin,' brightly colored bottles sold at gas stations containing tianeptine, an unapproved and potentially addictive drug that can cause serious side effects, with emergency calls related to its use rising significantly in the U.S.
A person experienced severe knee pain after taking OTC allergy medication levocetirizine, which resolved upon discontinuation, highlighting a rare side effect and the importance of awareness about medication reactions.