Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny: Marketing's "Ethical Concerns"

"Facing growing evidence that some of America's top-selling diabetes medicines could lead to pancreatic disease, federal regulators [see FDA notice here] on Thursday opened an unusual review of drugs from Merck & Co., Bristol-Myers Squibb Co. and other pharmaceutical makers," reports the Wall Street Journal (here).Some of the "evidence" may have come from Public Citizen in a petition it filed in 2010 with the Food and Drug Administration (FDA). That petition called on the agency to "immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits."The Public Citizen press release states the case regarding pancreatitis:"Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported. In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of takin...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: Drug Safety Victoza FDA Avandia Januvia Paula Deen Ethics diabetes Source Type: blogs