FDA Panel OKs Seroquel for Treatment of Depression, But Concerns Remain

In a closely watched decision involving one of the world’s top-selling drugs, an advisory panel to the Food and Drug Administration has said the antipsychotic Seroquel should be approved for treatment of depression.

The panel advised, however, that concerns about side effects from the drug should prevent it from being used alone and that Seroquel should only be used when other depression treatments have failed. Also, the panel recommended that the drug should not be approved for treating generalized anxiety disorder, which affects an estimated 15 million people in the United States.

The FDA is expected to adopt the recommendations of its advisory panel of medical experts and expand the approved uses of Seroquel at a future date.

Seroquel Linked to Serious Injuries

Seroquel is already approved to treat schizophrenia and bipolar disorder. It is one of drug maker Astra Zeneca’s top-selling drugs, having earned $4.45 billion in sales in 2008. The drug has been linked to sudden cardiac death, diabetes, weight gain, and other complications in patients, including a severe neurological disorder called tardive dyskinesia.

Patients with tardive dyskinesia may suffer from involuntary movements of the hands, legs, and torso as well as smacking of the lips and tongue protrusion. There is no known cure for the condition and the FDA has previously warned people taking Seroquel about the risk of developing the condition.

Astra Zeneca is named in thousands of lawsuits filed across the United States alleging Seroquel caused injuries. An FDA decision to approve Seroquel to treat depression would mean millions more patients may be given the drug.

FDA Notes Risks in Approving Depression Treatment

The FDA has admitted there is “accumulating evidence” to show that Seroquel may have “substantial metabolic risk” that can lead to deadly cardiovascular problems and diabetes.

The chance of people taking Seroquel developing tardive dyskinesia is considered an acceptable risk in schizophrenic and bipolar patients, but the risk increases with the possibility of wider use of drugs that are linked to the side effect, the FDA said.

The FDA also notes concerns that Seroquel and similar antipsychotics could increase the risk of sudden cardiac death, as previous studies have suggested.

AstraZeneca officials say there is no evidence to show that Seroquel increases the risk of sudden cardiac death, but that more long-term studies are planned to look at cardiovascular and diabetes risks associated with use of the drug.

Also, company officials said Seroquel should be used only in depressed patients for whom other front-line treatments have failed.

Broadening of Seroquel Uses is Troubling

Today’s preliminary approval for Seroquel to be prescribed to as many as 20 million more people diagnosed with depression, despite many studies finding serious problems in people taking the drug, are disheartening. Patients rely on the FDA and its advisory panels to evaluate new drugs and new uses of existing drugs impartially and reach reasoned rulings on how the drugs may be used. In the case of Seroquel, the FDA panel seems to be overlooking vast medical research linking the blockbuster drug to severe complications including diabetes and neurological disorders. This may be a good case where the FDA should refuse to implement the recommendation of its advisory panel.

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