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Multaq®

Multaq® was approved for use in 2009. Although it can be helpful for some, it can be deadly for those who have experienced severe heart failure. Even though Multaq® is used to treat those who have had irregular heartbeats in the past, it can be life threatening for those who continue to have an irregular heartbeat. If you have a permanent atrial fibrillation, you should not be taking Multaq®.

Most people who take Multaq® do not experience serious side effects. Nausea and diarrhea are not uncommon, but these symptoms are generally not severe. However, you should still let your doctor know if these problems seem to be a continuous or regular issue.

You should also talk to your doctor immediately if you suffer from any of the following potentially serious side effects:

  • Symptoms of liver disease (e.g., loss of appetite, abdominal pain, yellowing eyes or skin, dark urine, and/or vomiting)
  • Signs of kidney problems (changes in your amount of urine)
  • Slow, fast, or irregular heartbeat
  • Dizziness
  • Fainting
  • Signs of an allergic reaction (rash, itching, swelling, etc.)

Multaq® can also cause a condition known as QT prolongation. This condition can cause fast and irregular heartbeats, dizziness, and fainting. If you have any of these symptoms, you should seek medical attention as soon as possible. Although QT prolongation is rarely fatal, death is possible.

For those who have long-term problems with an irregular heartbeat, taking Multaq® can increase your risk of stroke, hospitalization, and even death. The medication is not meant to treat long-term conditions; it should only be used to treat temporary heart rhythm problems.

FDA Warnings Associated with Multaq®

In 2011, the FDA issued warnings regarding Multaq® and liver injuries. The FDA noted that although the situation was rare, Multaq® could cause severe liver injuries that may lead to liver failure and require a liver transplant.

To prevent liver damage, the FDA recommends that doctors take care to warn patients of the potential for liver problems while taking Multaq®. Doctors should also test for potential liver problems within the first six months of taking Multaq®. If you have a history of liver problems, you should not be taking Multaq®.

The FDA also issued warnings in 2011 that explained the dangers of taking Multaq® if you have permanent atrial fibrillation (AF). For those patients, Multaq® increases the likelihood of serious cardiovascular events and even death. At that time, FDA required that Multaq®’s label be modified to include additional warnings, one of which notes that “Multaq® doubles the rate of cardiovascular death, stroke, and heart failure” in those with atrial fibrillation.

It also recommended that patients who have AF stop taking Multaq® and that even those without AF should be routinely monitored to ensure that cardiovascular problems are not occurring.

In its warning, the FDA also noted that a study conducted on those with permanent atrial fibrillation was concluded early because of the significant increase in deaths for those on Multaq® compared to the placebo group. It also stated that it continued to believe that Multaq® is effective for those who do not have permanent atrial fibrillation.

Today, Multaq® carries a black box warning, one of the most severe warnings the FDA uses for medications. The FDA believes this warning is necessary given the high rate of death in those with permanent atrial fibrillation. The warning also addresses concerns with liver failure and related problems as well.

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Multaq® Lawsuits Focus on Failure to Warn

Because the FDA had to issue these warnings in 2011 regarding Multaq®, that meant that it did not already know about the problems. As such, lawsuits that involve Multaq® usually involve victims or families of victims that were not told about the serious side effects that Multaq® may have on those with prior liver problems or permanent AF. Part of the argument in these lawsuits is that if the manufacturers of Multaq® would have properly disclosed these risks, then patients would not have taken the medication or doctors would not have prescribed it to certain individuals.

The FDA issued a warning letter to Sanofi-Aventis U.S., the manufacturer of Multaq®, in 2011. The letter addressed concerns with:

  • Inadequate procedures for surveillance, evaluation, and reporting of adverse events resulting from use of Multaq®
  • Failure to report serious and unexpected drug experiences regarding Multaq®
  • Failure to include the results of all postmarketing studies in the annual report to the FDA

The FDA also expressed concern about validating the studies and the potential for inaccurate assessments. The warning also involved other drugs as well.

These warnings are extremely serious, particularly because the studies later indicated such severe problems for those with permanent AF and liver problems. As such, Multaq® lawsuits for those negatively affected by the drug have sprung up across the country.

If you or a loved one has been negatively affected by Multaq®, you may have legal options. Schedule an appointment with one of our team members by using our online contact form or call 800-800-4600 today and our experienced defective product attorneys will review your information right away.

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