Sanofi-Aventis Multaq Heart Drug Causes Death, Disability & Specific Risk To Pregnant Women
Since its approval last year, the Sanofi-Aventis Multaq heart drug has been controversial. For instance, a study published last spring found the pill is only modestly effective and has no clear safety benefits and more recently, questions were raised about the study that led to FDA approval. Now, a new analysis of FDA adverse event reports indicate Multaq may cause or worsen heart failure, trigger potentially lethal irregular heartbeats and impair kidney function. There is also a glaring discrepancy between the language in the Med Guide given docs and patients, and the warning label about pregnant patients. And the findings led The Institute for Safe Medicine Practices, which conducted the analysis, to conclude that we have seldom seen a drug with so many issues in so many areas of its safety profile. Why? The non-profit points out that development stopped several years ago after a study of patients with severe heart failure found the drug doubled the risk of death; other data found signals of cancer and birth defects in animals; there are potentially serious interactions with other drugs used to treat atrial fibrillation, and Multaq causes new heart rhythm disturbances in some patients. In its analysis, ISMP found 387 domestic serious adverse events cited Multaq as he primary suspect in reports involving 24 deaths, two cases of disability, and 361 other serious reactions. Overall, 25.8 percent indicated new or worsened heart failure. Heart rhythm disturbances were also reported, including 18 potential cases of abnormally slow heartbeats, 47 cases of rapid heartbeats and 13 cases of ventricular tachycardia. There were also 15 cases of kidney failure or impairment, including four cases of acute kidney failure, but computer excerpts did not provide sufficient info to evaluate them, ISMP reports. The non-profit notes the FDA classified Multaq is teratogenic, or a risk for pregnant women.
Ed Silverman, Pharmalot
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