February 21, 2012, 10:30:00AM. By Heidi Turner

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Spokane, WA: Patients concerned about the risk of Multaq side effects can probably be forgiven, since their concern comes on the heals of an FDA Multaq warning. The warning, issued in December 2011, warned about the risk of Multaq heart problems—a concern because Multaq is approved to treat atrial flutter. But the FDA's January Multaq warning was not the first about the drug in 2011.

In July 2011, the US Food and Drug Administration (FDA) issued a warning that the use of Multaq was potentially linked to an increased risk of liver damage. According to the agency (7/21/11), some patients who took Multaq suffered liver damage, including two patients who eventually required a liver transplant. The agency noted that neither patient had preexisting liver problems.

That FDA warning might have been enough to make some patients question their use of Multaq, even if they ultimately continued taking it. But the FDA's warning in December 2011, about the risk of cardiovascular problems, might have been a cause for alarm. That warning came after the FDA announced it was reviewing data from a clinical trial, which was stopped early after evidence arose about an increased risk of death in patients who took Multaq. According to reports, the risk of death, stroke and hospitalization from cardiovascular problems was two times higher in patients who took Multaq compared with patients who took a placebo.

Concerning to patients is that Multaq is approved to treat cardiovascular problems, including atrial flutter and paroxysmal or persistent atrial fibrillation. The FDA has warned that doctors should not prescribe Multaq to patients who have "Permanent Atrial Fibrillation [that] cannot or will not be converted into normal sinus rhythm" because of the risk of cardiovascular death, stroke and heart failure. Furthermore, patients who have severe liver problems are also advised not to take Multaq.

Multaq, which is made by Sanofi Aventis, was approved for use in July 2009. It was not approved to treat permanent atrial fibrillation—the condition that the FDA is concerned about. Doctors may have prescribed Multaq off-label for permanent atrial fibrillation. Patients who are currently taking Multaq should not discontinue medication without speaking to their physician first.

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