Tuesday, January 24, 2012

Actos® and Myocardial Infarction

After a Journal of American Medical Association publication of a meta-analysis suggested that long-term use of the diabetes drug Avandia was associated with an increased risk of myocardial infarction, the maker of Avandia, GlaxoSmithKline, declared there was little difference in the safety profile of their drug, Avandia and the “other” drug for Type 2 diabetes, Takeda Pharmaceutical’s Actos. Further studies however have not completely backed up that declaration. In nineteen separate controlled trials, involving over 16,000 patients, the end results demonstrated that while 4.4 percent of the patients who received Actos underwent myocardial infarction or stroke 5.7 percent of patients receiving control therapy suffered a myocardial infarction.

In the same studies, serious heart failure was reported in 2.3 percent of those taking Actos, while only occurring in 1.8 percent of those in the control group. The author of the results of the studies, Michael Lincoff, stated that not only does Actos—also known as pioglitazone—not appear to have the same level of detrimental effects as Avandia, but it could potentially have a protective effect on the heart. Takeda Pharmaceuticals, currently struggling under the rash of lawsuits filed against them due to evidence that Actos may significantly increase the risk of bladder cancer, does not believe their drug is responsible for episodes of myocardial infarction, or heart attack.

Other studies are not so quick to absolve Takeda Pharmaceuticals from their drug’s responsibility to potentially cause myocardial infarction, and the FDA has mandated that all those who take Actos be thoroughly warned about the possibility that it could bring about a serious or fatal heart attack. Actos is Takeda’s primary drug, accounting for over 15% of all new prescriptions in the United States. Type 2 diabetes affects as many as twenty million Americans, and is characterized by the body’s inability to respond to insulin as it should. When Type 2 diabetes is left untreated, it can lead to a myriad of other health problems, including cardiovascular disease.

Another study done in 2007 revealed little significant differences between Actos and Avandia as far as the increase in risk of myocardial infarction. At least twelve specific cases have indicated a direct correlation between Actos and myocardial infarction. The age of the patients ranged from 50 to mid-80’s, and were reported in 2009 and 2010 by their physicians who believe their deaths were a direct result of taking Actos. Although the current studies may show little agreement as to whether Actos can directly cause myocardial infarction, the fact that the FDA requires Takeda to list myocardial infarction as a potential serious side effect should definitely make those taking the drug consider alternative therapies. Especially for patients with a history of cardiovascular risks, taking Actos could cause a worsening of those risks along with a possible increased risk of bladder cancer.

Germany, France and New Zealand all believe that the risks of Actos far outweigh the benefits and have subsequently removed them from use. The FDA is reserving final determination on the risks of Actos until further studies have been conducted, and although they require a black box warning on the drug, it will remain on the shelves—at least for now.

Author: Sullo & Sullo Attorneys

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