September 12, 2012 — The U.S. Food and Drug Administration (FDA) and drug company Sanofi-Aventis are making changes to the label for Multaq (dronedarone), a drug used to treat atrial fibrillation.
The new label will include a new warning regarding Pulmonary Toxicity. The label will also contraindicate Multaq for people with hypersensitivity to the drug, because they may be predisposed to develop a type of small blood vessel disease.
Under Warnings and Precautions, the following new sub-section has been added:
- Pulmonary Toxicity: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in patients treated with MULTAQ in the post-marketing setting [see Adverse Reactions (6.2)]. Onset of dyspnea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically. If pulmonary toxicity is confirmed, MULTAQ should be discontinued.
Under “What are the possible side effects of MULTAQ,” the following information has been added:
- Inflammation of the lungs, including scarring and thickening. Call your doctor if you develop shortness of breath or a dry cough during treatment with MULTAQ.
Under Adverse Reactions/Postmarketing Experience, the following has been added:
- Vascular: Vasculitis, including leukocytoclastic vasculitis.
Vasculitis is an inflammation of the blood vessels. The vessels can thicken, weaken, narrow, and become scarred. Over time, chronic vasculitis can decrease the amount of blood that flows into organs, causing tissue damage and organ failure. Leukocytoclastic vasculitis, also known as “hypersensitive vasculitis,” is a type of small blood vessel disease. It usually manifests as a skin inflammation, but may also involve organs including the lungs. The condition may be sudden and acute, or chronic and recurrent.
In recent years, Multaq has been linked to several serious side effects. The FDA issued three major announcements in 2011. The first was issued in January 2011, when the FDA received two reports of acute liver failure in patients treated with Multaq. The second was issued in July 2011, when a study had to be halted after researchers linked Multaq to a doubled risk of death, stroke, and hospitalization for heart failure. In December 2011, the FDA said that Multaq may still be beneficial for people with non-permanent atrial fibrillation. Health authorities in Europe have already restricted sales of Multaq.
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