Multaq Side Effect Concerns Prompt Restrictions in Europe

Use of <"">Multaq, the Sanofi-Aventis heart drug that has been linked to heart, liver and lung problems, has been restricted by regulators in Europe. According to a report from The Wall Street Journal, a committee of the European Medicines Agency (EMA) said Multaq shouldn’t be used in most people with permanent atrial fibrillation, but left it on the market for some patients with a more intermittent form of the disease. However, the agency also cautioned doctors to consider other atrial fibrillation treatments before they prescribe Multaq.

According to a Reuters report, the EMA’s Committee on Medicinal Products for Human Use (CHMP) recommended that patients currently taking Multaq have their treatment evaluated by their doctor at their next scheduled appointment. The panel also said Multaq “should only be prescribed for certain heart disease cases including arrhythmia at varying intervals and some types of persistent atrial fibrillation following certain successful medical procedures,” Reuters said.

According to a report from HeartWire, the new Multaq recommendations are based on a review of the PALLAS trial, as well as other data suggesting an increased risk of liver and lung injury with dronedarone. As we reported previously, the PALLAS trial involved patients over 65 with permanent atrial fibrillation, and was halted earlier this summer after patients taking Multaq experienced a higher-thanexpected frequency of adverse heart events, including cardiovascular death and stroke. Based on its review, CHMP said it had concerns that the “cardiovascular events shown in the population in the PALLAS study could mean an increased risk of cardiovascular side effects for some patients with nonpermanent atrial fibrillation,” HeartWire said.

The U.S. Food and Drug Administration (FDA) is currently conducting its own review of the safety of Multaq, but has not yet reached a decision. In January, the FDA announced that the U.S. label for Multaq had been updated, following reports of liver damage, including severe liver failure, associated with the drug. The halt of the PALLAS study prompted the FDA to announce in July that it was expanding its review of Multaq, and the agency recommended that people taking Multaq speak with their physicians about the need to continue taking it. The FDA also reminded physicians that Multaq should not be prescribed to people with permanent atrial fibrillation.

A report published yesterday by The Wall Street Journal said that the FDA is coming under increasing pressure to place restrictions on Multaq, even as more physicians stop prescribing it due to safety concerns.

According to Reuters, when it was approved in 2009, Multaq was expected to be a blockbuster for Sanofi-Aventis, and analysts saw Multaq’s potential annual sales exceeding $1 billion. But current forecasts predict sales of just around $570 million in 2016.

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