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The US FDA has issued a direct final ruling on the use of partially hydrogenated oils (PHOs) in food, saying that it is no longer generally recognized as safe, updating outdated references to PHOs in regulations. These actions are regarding the addition of artificial sources of trans fats; however, trans fat cannot be completely removed …
The drug, called Mounjaro, was approved for type-2 diabetes earlier last year and is currently under review for use in the treatment of obesity and being overweight. Experts are anticipating approval from the agency by 2024. Once approved, Mounjaro becomes the latest in a slew of newly FDA-greenlit weight loss medications that aim to address …
Benzodiazepines and opioids include two of the most dangerous drugs of abuse on the market and on the streets today. There’s so much to learn about the dangers of these drugs on their terms. One helpful resource is the drug warnings the Food and Drug Administration (FDA) posts. However, the FDA has also released updated …
According to the FDA press release, Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy. The FDA has identified this as a Class I recall, the most serious type of recall. The use of these …
According to the FDA’s news release, the agency has issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement …
The U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This …
According to a Safety Summary Alert, the FDA has announced that Lupin Pharmaceuticals is recalling multiple lots of two different medications, irbesartan tablets and irbesartan and hydrochlorothiazide tablets, used to treat hypertension. The reason for the recall is the potential presence of unacceptable levels of N-nitrosoirbesartan, a contaminant associated with cancer. At this time, there …
On August 27, 2021, the U.S. Food and Drug Administration approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve …
FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health. This Action Marks The First Marketing Denial Orders for E-Cigarette Products; Products Receiving Such Orders Must be Removed from the Market or Risk Enforcement; More Marketing Decisions to Follow. According to a press announcement on …
According to a press announcement the US FDA has approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased …