FDA snubs Seroquel

In a unanimous vote, a US Food and Drug Administration advisory panel determined that AstraZeneca's antipsychotic drug Seroquel has too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

Seroquel is widely used in South Africa and is commonly prescribed for ailments ranging from bipolar disorder to anxiety.

However, in a separate 6-to-3 vote, the panellists recommended that the medication could be used as supplemental treatment for patients with depression who do not get symptom relief from other drugs, the Associated Press reported. The expert panel did not hold a similar vote for anxiety disorders.

No clear advantages
Overall, "I saw no clear advantage demonstrated in efficacy," said Dr Wayne Goodman, the panel's chairman and a psychiatric researcher at the US National Institutes of Health. "There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug."

The FDA is not mandated to follow its advisory panels' advice, although it usually does. Federal health officials have already approved the use of Seroquel (quetiapine) and drugs like it to treat schizophrenia and bipolar disorder.

May pose heart risk
This decision, by a panel of psychiatric experts, follows a study released earlier this year that suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks - specifically, a higher risk of sudden death due to cardiac arrest. The study was published in the January 15 issue of the New England Journal of Medicine.

At the time, experts said that the overall odds of a heart problem for patients taking this class of medications - which also includes clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal) - were probably low, and the drugs remained appropriate for certain patients. Still, doctors, families and patients should be cautious, according to the study's lead author, Wayne Ray, director of the Vanderbilt University School of Medicine's Division of Pharmacoepidemiology.

"If they're being used for schizophrenia, consider a cardiology evaluation. If you're considering using them for bipolar disorder, think about using another alternative drug first," Ray told HealthDay in January.

Not for use in other conditions
And patients should rarely, if ever, take the drugs to treat other conditions, he said. However, doctors have also prescribed them for so-called "off-label" uses to treat conditions such as anxiety, attention deficit disorder in children and dementia in the elderly.

"For schizophrenics, they work pretty well. They're pretty much the only alternative," Ray said. But other drugs offer alternatives for bipolar patients, he noted.

In their study, Ray and his colleagues expanded on earlier research that suggested the newer drugs disrupt the heart's rhythm. The team found that users of the newer drugs were 2.26 times more likely to suffer from sudden cardiac death than those not on the medications. Those who used the older drugs were 1.99 times more likely to die versus those not taking the medications.

The drugs appear to cause problems by disrupting potassium in the heart, causing its electrical rhythm to fail, Ray said.

Manufacturers pleased with results
In a statement released Wednesday, Dr Howard Hutchinson, chief medical officer of AstraZeneca, which makes Seroquel, said the company was "pleased" that the panel found Seroquel appropriate as adjunctive therapy for depression.

Acknowledging that the panel "had concerns around the long-term safety profile in these new populations," Hutchinson said that he and his colleagues "look forward to having further discussions with the FDA" regarding the new drug applications.

In the meantime, AstraZeneca is fending off claims from thousands of former Seroquel users that the UK-based drug maker held back data on the drug's risks, according to the Associated Press. Seroquel's labelling now alerts users to heightened risks for high blood pressure, diabetes and death. – (Randy Dotinga and E.J. Mundell/HealthDay News, April 2009)

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