Seroquel to Get New Heart Warnings

Following a request from the U.S. Food and Drug Administration (FDA), AstraZeneca will be including a new cardiac warning to <"">Seroquel labels, The New York Times reports.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. In recent years, AstraZeneca has faced over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.

The revised label was mentioned on the <"">FDA website last week and indicated that both Seroquel and the extended-release version of the drug, Seroquel XR, “should be avoided” when used with about one dozen other drugs that are connected to heart arrhythmia, which can lead to sudden cardiac arrest, reported The New York Times.

According to Sandy Walsh, an FDA spokeswoman, the label change was prompted by new information received by the agency concerning arrhythmia reports in 17 people who took more that the recommended Seroquel doses, according to The New York Times. Arrhythmias are liked to thousands of deaths annually and have to do with the heart’s electrical rhythm, noted The New York Times.

Earlier this year, we reported that U.S. health regulators ordered cautions be added to ALL antipsychotic drug labels regarding their risk of abnormal muscle movements (extrapyramidal symptoms or EPS) and withdrawal syndromes in newborns when used in pregnancy. The new cautions will apply to older and new generation antipsychotics, in addition to Seroquel, that also included Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax, according to an FDA alert.

The FDA said at the time that it identified 69 episodes of neonatal EPS or withdrawal in U.S. adverse event reports submitted to the agency through October 2008. Among the symptoms listed in the reports: agitation, hypertonia, tremor, somnolence, respiratory distress, and feeding disorder. Onset of symptoms ranged from birth to one month later, and the severity varied as well.

Atypical antipsychotics, like Seroquel, are favored by many doctors and patients because they carry a decreased risk of side effects related to loss of motor control, a major problem with older “typical” antipsychotics. But Seroquel and similar drugs carry other safety risks, such as increased risks for weight gain and diabetes. In 2003, the FDA required the makers of atypical antipsychotics to re-label them to include warnings regarding their risk of hyperglycemia and diabetes mellitus. In 2005, the FDA also warned that such drugs increased the risk of death among elderly people.

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