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US sees death concern in schizophrenia drugs

-Reuters

04/03/2009 - U.S. regulators are concerned about a potential risk of sudden death with schizophrenia drugs from AstraZeneca Plc and H Lundbeck A/S, documents released on Friday showed.

Danish drugmaker Lundbeck is seeking U.S. approval to market Serdolect, a schizophrenia drug sold in Europe, while AstraZeneca has applied to more widely promote its approved blockbuster schizophrenia treatment Seroquel XR for patients with depression and anxiety.

Lundbeck's drug was up for Food and Drug Administration review in 1998 when the company's partner at the time, Abbott Laboratories Inc, withdrew its application for approval amid fears that the drug might cause heart problems.

In a memo released on Friday, the FDA's director of psychiatry drugs said cardiac effects still raise questions about the drug's safety.

"There remains ... a concern about a possible risk of sudden cardiac death with this drug," Dr. Thomas Laughren wrote in a March 10 memo.

Other FDA documents noted a recent report in the New England Journal of Medicine that raised the same issue with other medicines in the family known as atypical antipsychotic drugs, including Seroquel.

Both Serdolect and Seroquel XR will be reviewed by FDA advisory panels of outside experts who meet next week.

Shares of AstraZeneca fell 3 percent in London trading, while Lundbeck shares dropped 3 percent in trading in Copenhagen.

Schizophrenia is a chronic mental illness that causes hallucinations, delusions, social withdrawal and disorganized thoughts.

Lundbeck said Serdolect offers a distinct advantage over other schizophrenia medicines by reducing suicide attempts by up to 50 percent. Suicide is a major risk for patients with schizophrenia.

The company also said heart-related effects could be managed by withholding the drug from patients with a condition that raises the chances of suffering sudden death.

"With this positive benefit-risk profile, (Serdolect) offers an effective treatment modality," the company said in a summary prepared for the FDA panel.

FDA statistical reviewers, however, said data on suicides and suicide attempts "trended in favor of" Serdolect but were "inconclusive" based on the agency's preferred analysis.

With Seroquel XR, FDA staffers voiced concern about known potential complications including weight gain and tardive dyskinesia, which causes involuntary, repetitive limb and mouth movements, as well as sudden death.

"These issues become even more important as the distribution of this drug to a much broader patient population is considered," the FDA's Laughren wrote.

The FDA advisory panel will review Lundbeck's Serdolect on Tuesday and Seroquel XR on Wednesday. The agency will consider the panel recommendations before deciding whether to grant approval.

At Wednesday's session, the committee will hear from FDA reviewers, AstraZeneca and the author of the New England Journal report on heart risks of atypical antipsychotic drugs.

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