More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human
Drug Companies’ Ads for Doctors are not FDA Compliant
Four out of five ads in medical journals targeting doctors fail to follow FDA guidelines. Over half fail to quantify the risks. Dr. Deborah Korenstein, lead author of a recent study and Associate Professor of Medicine at Mount Sinai School of Medicine states:
Marketing research has consistently shown that journal advertising is the most profitable form of
…
FDA Taking Another Look at Dangers of Yaz and Yasmin
The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We’ve been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the…
FDA’s Role In Approving Yaz and Yasmin Examined
The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expert, Professor James T. O’Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits. Mike talked about the lawsuits while Professor O’Reilly provided his insights on what the FDA does and, more importantly, does not do when…
Yaz and Yasmin: Drug Company Places Profits over Safety
The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young women, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and…
FDA Determines Yasmin/Yaz Commercials Misleading
Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer’s predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected. The FDA warned Bayer again in 2008, and again in 2009. Among Bayer’s more serious violations, according to the FDA, was that the…