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safety data 6 articles

GSK revamps marketing efforts following record settlement over illegal promotion of drugs

GlaxoSmithKline (GSK) says it will hire doctors to market its drugs to the medical community in an effort to mend its tarnished reputation following a $3 billion fraud settlement over questionable marketing practices. Since 2012, when GSK was accused of illegally promoting its antidepressants Paxil and Wellbutrin and failing to report safety data on its blockbuster diabetes drug Avandia, the drug company has been reforming its marketing efforts to provide more transparency. “We’ll continue to disseminate this very important information on drug benefits and risks, but we’re just not going to do that by hiring external speakers. We want to ... Read More

FDA rejects experimental sleeping pill for people with insomnia

A first drug in a new class of insomnia treatments was rejected by the Food and Drug Administration (FDA) because the agency said safety data didn’t support approval of the treatment at the dosing proposed. The drug, called suvorexant, made by Merck & Co., was under review by the FDA in both 30- and 40-milligram doses. The FDA advised Merck that suvorexant was effective at doses as low as 10 milligrams up to 40 milligrams, with 10 milligrams seen as the starting point. As a result, the FDA advised that Merck seek approval for the lowest dosage before it grants ... Read More

GSK to pay an additional $90 million in Avandia heart attack claims

GlaxoSmithKline (GSK), makers of the type 2 diabetes drug Avandia, agreed to pay $90 million to settle claims by 37 states and the District of Columbia that the drug company illegally promoted the medication and misled consumers about whether the blockbuster prescription medication caused deadly heart attacks and strokes in order to boost sales. The settlement is yet another financial blow to GSK, which has already paid more than $3 billion to resolve government investigations into questionable marketing of Avandia and other drugs. One of the charges involved the company’s failure to report safety data about Avandia. Avandia is in ... Read More

Dr. Oz show investigates risks, benefits of new diet drug

An investigational diet drug is getting media attention from celebrity doctor Dr. Oz as the “New Silver Bullet for Weight Loss,” but the Food and Drug Administration (FDA) has yet to approve the drug based on health concerns including heart problems and birth defects. The new drug, made by Vivus, is Qnexa, a combination of phentermine and topiramate. Phentermine is a stimulant that is FDA approved as a diet pill to aid in weight loss. It was once part of the wonder drug fen-phen, which was banned in 1997 for damaging heart valves. Tropiramate, also known by the brand Topamax, ... Read More

Lawsuits mount against Actos diabetes drug maker

If you have taken the type 2 diabetes drug Actos and were diagnosed with bladder cancer, you may have a case against the manufacturer. More and more lawsuits are being filed against Takeda Pharmaceuticals by people who claim the company knew the drug could cause cancer but intentionally hid it from the public. Among the latest lawsuits to be filed are those by three couples in Illinois. The lawsuits say the men took Actos as part of their doctors’ plans to treat their type 2 diabetes. It wasn’t until years later the men allege they learned that the medication they ... Read More

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns. Medical device makers are in favor of a plan that would allow for ... Read More