When you decide to take a medication for a serious condition like atrial fibrillation, you hope that the medicine will control the condition and without the added risk of serious side-effects like heart attack, stroke or death. But Multaq is a potentially dangerous drug that may have little benefit and much risk for patients with abnormal heart rhythms.
If you suffered the severe side-effects of Multaq or a family member died due to complications stemming from Multaq, the personal injury attorneys at Jacoby & Meyers may be able to help you seek compensation for your injury or loss. Please call us at 800-330-5342 for your free case evaluation; our lawyers welcome clients nationwide.
What is Multaq?
Multaq is the trade name for dronedarone, a medication approved by the Food and Drug Administration (FDA) in 2009 for the treatment of atrial fibrillation, a form of cardiac arrhythmia. Multaq, which is marketed by Sanofi (formerly Sanofi-Aventis), was shown to reduce the risk of hospitalization in people with this form of irregular heartbeat.
Multaq was developed as an alternative for another atrial fibrillation treatment that was linked to significant side-effects. It was hoped that Multaq would provide the same benefits with a reduced risk of resulting lung and thyroid damage.
Dangers of Multaq
Even before the drug became available to patients, there were signs of pharmaceutical injuries associated with Multaq. A small early study on mortality in patients using dronedarone was halted because of a significant death rate.
A larger and later study of Multaq showed the drug had little effect on mortality and significantly reduced hospitalizations in those with atrial fibrillation. The medication was approved with the condition that it should not be used for high-risk patients, such as those with permanent atrial fibrillation or who had suffered heart failure.
Another large study of Multaq, however, showed alarmingly high numbers of adverse cardiovascular effects, including heart failure, stroke and death. That study indicated that Multaq doubled the risk of death and more than tripled the risk of sudden death from arrhythmia, the very condition the drug is intended to treat. The study also showed that Multaq more than doubled the risk of stroke and heart failure.
These potential hazards, combined with the risk of liver and lung damage, led European regulators to recommend that Multaq use be restricted to patients who cannot tolerate other drugs. In the United States, Multaq is recommended only for patients with temporary atrial fibrillation, and these patients should be carefully monitored. Those taking Multaq are encouraged to talk with their doctors about their risk levels and alternative treatments.
In the two years following Multaq’s approval, more than 1.3 million prescriptions for the drug were filled for about 280,000 patients. This is a high number for a newer medication that has not demonstrated significant benefits over a generic alternative. One of the reasons for Multaq’s success is the marketing support of Sanofi, some of which existed in a gray area and was eventually amended in late 2012 at the request of the FDA.
Shortly after the drug was launched, the American College of Cardiology and the Heart Rhythm Society teamed up to launch a website titled “Atrial Fibrillation.” At first, Sanofi-Aventis was listed as the sole supporter of the site, although they later removed their name from the site. This website presented a supposedly independent lecture in which an expert gave his own views about Multaq; he openly criticized FDA labeling and made recommendations for off-label uses of the drug.
The expert was a paid consultant for Sanofi, though the company did not initially acknowledge that fact. The content in question was later pulled from the site amid increasing media scrutiny. Technically, it is illegal for a pharmaceutical manufacturer or marketer to advertise the drug for off-label uses or to overstate the benefits of a drug.
If you or a loved one suffered harm due to Multaq, you may be able to receive compensation for resulting medical expenses and other damages. To learn more about your legal options after injuries due to dangerous medications, please contact Jacoby & Meyers for your free case review and to locate a personal injury lawyer near you. Our experienced network of attorneys works with clients across the country.