Video: The FDA’s hidden database of medical device injuries

legal news for consumersThe Food and Drug Administration has a special “exemption” for medical device manufacturers that lets them file reports of malfunctions in a database that can’t be accessed by doctors or the public, reports HuffPost. Since 2016, there have been 1.1 million incidents that have been filed in an “alternative summary reporting” database, according to Kaiser Health News. While deaths caused by medical devices have to be reported to a public database known as MAUDE, the hidden database has serious injury and malfunction reports for about 100 medical devices. In this video interview  from Kaiser Health News, Phil Levering talks about his father, Mark, undergoing surgery for a liver abscess that was initially thought to be cancer.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

 

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

Bladder Cancer Risks Don’t Deter FDA from Approving First Generic Actos

NewsInferno; August 20, 2012

In spite of serious concerns that Actos (pioglitazone) can cause bladder cancer and other serious side effects, the Food & Drug Administration (FDA) has approved the first generic version of the type 2 diabetes drug for sale in the U.S.  According to a statement from the agency, Mylan Pharmaceuticals, based in Morgantown, West Virginia, has been granted approval to market 15, 30, and 45  milligram pioglitazone tablets.

Actos is one of the top selling type 2 diabetes medications in the world.  According to the FDA, generic versions of Actos will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.  However, critics of the FDA will surely raise concerns that widely available generic versions of Actos will put more patients at risk for its serious side effects, including bladder cancer.

Last June, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer.  That same month, the French and German governments decided to suspend sales of Actos in those countries after a separate study commissioned by French regulators demonstrated an increased risk of bladder cancer associated with Actos in people who took it the longest and at the highest cumulative dose. Takeda Pharmaceuticals has officially recalled Actos from the market in France.

Since the FDA issued its warning last June, a number of new studies have confirmed the link between Actos and bladder cancer.  Most recently, research  published in the Journal of the National Cancer Institute found that patients taking Actos and other thiazolidinediones face as high as a 3-fold increased risk of developing bladder cancer, compared to patients who use sulfonylurea drugs, another common class of type 2 diabetes medications.   Last month, a study published in the Canadian Medical Association Journal (CMAJ) found a 22 percent increased risk of bladder cancer when taking Actos. In May, a Canadian study published in the British Medical Journal found that taking Actos for two years doubled the risk of bladder cancer.

Takeda Pharmaceuticals has been named in a number of U.S. lawsuits that accuse it of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer.  Most Actos bladder cancer lawsuits have been consolidated in a multidistrict litigation in U.S. District Court, Western District of Louisiana. As we’ve reported previously, some legal experts estimate that Takeda could face as many as 10,000 Actos bladder cancer lawsuits in the U.S.

Bladder cancer is not the only side effect associated with use of Actos.  The drug already bears a Black Box Warning, the FDA’s most urgent safety notice, stating that it may cause or worsen congestive heart failure in some patients.  Actos is not recommended for anyone who has symptomatic heart failure. Studies have also linked Actos to fractures, and an eye disorder called diabetic macular edema.

http://www.newsinferno.com/pharmaceuticals/bladder-cancer-risks-dont-deter-fda-from-approving-first-generic-actos/40288