Jazz didn't notify FDA of 74 serious side-effect reports

The FDA has issued a stern warning to Jazz Pharmaceuticals ($JAZZ), saying the company failed to properly report serious side effects of its drugs. Jazz also failed to submit reports on 74 serious adverse events in patients using its narcolepsy drug Xyrem from 2003 to 2010, the agency maintains. At least 10 of the reports involved the death of a patient, Dow Jones reports.

The warning letter came after the FDA inspected Jazz's headquarters in April and May. Under agency rules, companies are required to pass along reports of serious adverse events within 15 days. Drugmakers are also required to investigate the reports. The reported adverse events haven't necessarily been caused by the drug in question, but found in patients who were taking it.

According to the warning letter, a representative said Jazz had not been aware of the adverse-event reports because they hadn't been made directly to the company, but to a specialty pharmacy that distributes Xyrem. The warning also said the agency had notified Jazz in 2007 of similar reporting violations.

- read the Dow Jones story
- see the FDA warning letter