A medication is supposed to heal, not harm, especially when it is for a serious condition like atrial fibrillation. Unfortunately, Multaq is a drug whose serious side effects can actually increase your risk of heart attack, stroke, and sudden death. Sadly, the dubious benefit of Multaq has been exaggerated by marketers, potentially leading to thousands of heart attacks, strokes, and deaths.
If you or a loved one started taking Multaq and suffered a serious heart attack, stroke, or other serious side effect, you may be able to receive compensation for injuries. To learn more about your legal rights, please contact a local personal injury attorney today
What Is Multaq?
Multaq (dronedarone) is a medication for atrial fibrillation, a form of irregular heartbeat or cardiac arrhythmia. Multaq, which is marketed by Sanofi-Aventis, was approved in July 2009 to reduce the risk of hospitalization for people with this condition, the sole verifiable clinical endpoint for which this drug gave benefit.
It was hoped that Multaq would provide benefits for atrial fibrillation patients without a risk of lung and thyroid damage, the side effects of a similar drug that has long been on the market. This competing drug amiodarone is available as a generic and works well for most atrial fibrillation patients, with the exception of the side effects.
Dangers of Multaq
Multaq showed signs of being a dangerous drug from the beginning. An early study on the drug was halted early because twice as many people died taking Multaq than taking placebo (a fake pill). The study was small, so statistically it could have been chance, but this risk would be borne out later.
Later, a large study of Multaq showed the drug had some effect on deaths, but significantly reduced hospitalizations. As a result of these studies, the drug was then approved with the condition that it should not be used for high-risk patients such as those in the earlier study that had been halted, who had permanent atrial fibrillation or who had suffered heart failure.
Finally, a large study of Multaq studying its use for an additional condition began reporting alarmingly high numbers of adverse cardiovascular effects, including:
- Death—More than double the risk with Multaq, triple the risk of death from arrhythmia
- Stroke—More than double the risk
- Heart failure—More than double the risk
These are the very conditions Multaq was supposed to prevent. As a result of these effects, the trial was stopped early, and on December 19, 2011, the FDA revised the labeling for Multaq, adding increased monitoring conditions.
Regulators in Europe looked at the risk of sudden death plus risk of liver and lung damage (similar to amiodarone) recommended that the use of the drug be restricted only to patients who could not tolerate other drugs.
People taking Multaq are encouraged to talk to their doctors about their risk level and alternatives.
Despite the dangers and at best dubious benefits associated with the drug, it has managed to capture nearly 30% of its potential patients in just over two years after its approval. From July 2009-October 2011, more than 1.3 million Multaq prescriptions were filled by about 280,000 patients. Based on the limited application for which the drug is approved, there are likely little more than a million patients in the population with the approved condition. Although this number is far below the numbers Sanofi-Aventis had hoped to post, it is nonetheless a significant achievement.
Multaq has done so well partly because of considerable marketing support from Sanofi-Aventis. Unfortunately, some of the marketing seems dubious. Shortly after Multaq was launched, the Heart Rhythm Society and the American College of Cardiology teamed up to launch an “independent” website called “Atrial Fibrillation.” Sanofi-Aventis was originally listed as the sole supporter of the site, though their name has since been removed from the site. This website presented, among other things, a supposedly independent lecture giving an expert’s own views about Multaq. Among his views: a stern criticism of FDA labeling and recommendations for off-label uses of the drug. The criticisms and off-label recommendations represent the only new content in the lecture, which was otherwise assembled from already-existing material. The same expert made a number of prominent appearances in the following months, all without disclosing ties to Sanofi-Aventis.
This vocal expert spouting off his own opinion was a paid consultant for Sanofi-Aventis. He was also the medical chair for another atrial fibrillation website sponsored by Sanofi-Aventis. The law forbids marketing of off-label uses for drugs, and Sanofi-Aventis denies responsibility for the lecture, saying, “This is independent of Sanofi.”
At this time, we do not know the exact relationship between the lecturer’s statements and Sanofi-Aventis, but this is not the first instance where the company has been accused of using third-party experts to covertly promote its medications. The company was accused of giving millions of dollars to organizations and individuals then influencing them to petition against the approval of a generic alternative to its billion-dollar drug Lovenox. A senate investigation revealed some very telling documents from inside the company that indicated the use of “independent” experts is a crucial part of the company’s marketing strategy.
Stopping Profits from Dangerous Drugs
The Multaq story shows how far a company will go to make money off a drug, even when that drug is known to be dangerous. Multaq was originally expected to be a blockbuster, but when dangers surfaced, Sanofi-Aventis had the option of accepting the drug would not be as profitable as originally thought. Instead, the company sought to make the drug as profitable as possible, despite the possibility of injury or death that went along with it.
To learn more about your legal options after suffering injury from this dangerous drug, please contact a local personal injury lawyer for a free case evaluation.