Sanofi-Aventis Cited For Not Reporting Problems with Multaq, Other Drugs

Drug manufacturer Sanofi-Aventis has failed to alert federal regulators to reports of severe problems with some of its drugs, including the heart drug Multaq, and has been cited and ordered to fix its adverse event reporting system. 

The FDA issued a warning letter to Sanofi late last month and made the letter public this week. The agency accused the company of failing to give the FDA serious and unexpected adverse drug experiences within 15 calendar days of receiving them. The company had inadequate procedures in place for handling and evaluating adverse events and has failed to turn over all postmarketing studies on some drugs, FDA inspectors said.

The FDA and Sanofi have been communicating over the problems since May 13, 2010. However, the FDA notes in the warning letter that Sanofi has responded three times to FDA’s concerns and each response was inadequate to address the side effects reporting problems.

According to the warning letter, the FDA has identified 13 instances where adverse events were reported to Sanofi, but not passed on to the agency within the 15-day time limit. In some cases the adverse events were reported more than two years after being submitted. Three of the reports involved problems with Multaq, which the FDA warned last month could be linked to severe liver damage.

Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months. In less than two years since its approval, there have been at least 492,000 Multaq prescriptions in the United States filled by about 147,000 patients at outpatient pharmacies across the country. In addition, the drug can be given to patients being treated in hospitals.

The FDA issued a warning about Multaq liver problems in January, after reports indicated that two patients on Multaq suffered acute liver failure that required them to get liver transplants. It is unclear whether the two reports were included among those that Sanofi failed to submit to FDA on time.

The company also failed to give the FDA the results of completed, unpublished clinical trials for the sleep aid Ambien and other drugs.

Ambien (zolpidem) is a sedative manufactured by Sanofi-Aventis, which is one of the best selling medications in the United States. It is heavily marketed through direct to consumer advertisements to help people fall asleep and stay asleep with an extended release version.

Some users of the drug have suffered catastrophic or fatal injuries as a result of Ambien sleep walking side effects. While the user is half asleep and half awake, they may do things that they would not do if they were awake or attempt to do things they are not alert enough to do. Reported injuries have occurred as a result of car accidents, falls, cooking injuries like fires and even people eating raw meat. However, hard scientific evidence explaining the phenomenon has been difficult to produce.

Sanofi has 15 working days from the date it received the letter to respond to the FDA’s concerns. Failing to address and correct the violations could result in legal actions and fines against the company.