For years, consumers relied on the false representation that the Type-2 diabetes medication, Actos (pioglitazone), was a safer alternative than the competing drug, Avandia. This belief arose in large part from misinformation by drug companies and the U.S. Food and Drug Administration (FDA) that Actos posed less of a risk of dangerous side effects. Based, in part, on this misinformation, sales of Actos rose to $4.6 billion in 2010 while sales of Avandia plummeted from $3.4 billion in 2006 to $1.1 billion in 2010. However, reports have recently emerged suggesting that Actos, in actuality, is no safer than Avandia. In fact, Actos poses about the same risks as Avandia to users of the drug. The FDA is only now acknowledging that serious cardiovascular side effects, even death, can result from the use of Actos.
In 2007 it was suggested that the FDA knew about Actos’ cardiovascular risks but failed to take any remedial measures. In fact, the FDA became subject to criticism by several health care professionals and lawmakers for failing to take corrective action or warn consumers about the dangers of Actos. In several instances, the FDA was even asked to place black box warnings on the Actos label by, among others, drug safety advisors, but nevertheless failed to do so.
The FDA has now asked the manufacturers of Actos to issue a black box warning identifying the dangerous cardiovascular side effects associated with the drug. The black-box warning is the strongest warning that the FDA can request to be put on a medication label. The FDA has also taken on a serious investigation into the dangers of Actos to determine whether a drug recall is necessary. Adverse cardiovascular events linked to Actos have been reported to include heart failure, heart attack, and death caused by a compromised cardiovascular system. Since the disease of Type-2 diabetes itself also increases the risk of cardiovascular disease, any adverse cardiovascular complications have been of particular concern to diabetes patients.
Actos (pioglitazone) is manufactured by Takeda Pharmaceutical Company. In the United States the oral diabetes medication is co-marketed by Eli Lilly Pharmaceuticals. Actos became FDA approved on July 15, 1999. Type-2 diabetes medications such as Actos work by lowering an individual’s glucose levels and reducing the body’s tissue insulin resistance. Actos is in a class of medications called Thiazolidinedione drugs, which are believed to be the strongest drugs available for the treatment of Type-2 diabetes.
The FDA needs to take more seriously the evidence of dangerous side effects of medications brought to its attention by professionals. Particularly, as here, when suggestions are made by the FDA’s own agents and drug safety advisors, the FDA should make an effort to incorporate those suggestions so that the health of all consumers is maintained as a high priority. Consumers should have the opportunity to receive the most information possible before making the decision to take any drug. Although the FDA is now investigating whether place a drug recall on Actos, and has encouraged the placement of a black box warning on Actos’ label, this safety action may have come too late for several consumers. The FDA needs to take safety precautions, early on, and mandate responsible efforts by drug manufacturers to ensure that any dangerous side effects of a medication no longer go unidentified and undetected.