The U.S. Food and Drug Administration (FDA) just announced that while AstraZeneca’s schizophrenia and bipolar disorder medication, Seroquel, can be taken to treat depression, there are side effect concerns that include the risk of a sudden cardiac death, reported the Associated Press (AP).
The AP said that Seroquel XR is taken by millions of patients for schizophrenia and bipolar disorder, but that AstraZeneca is hoping the FDA will approve the drug for depression and anxiety disorder, which accounts for an additional 20 million Americans. In response, the FDA is asking an external panel to look at the drug’s side effects, including weight gain and tics, said the AP.
The Wall Street Journal reported that the external panel will conduct its review of the extended release medication on April 8 and that the FDA said the review will look at “concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.” Tardive dyskinesia is a neurologic disorder.
“There remains a concern about longer-term risks with this drug, in particular, risks related to metabolic changes,” said FDA drug reviewer Thomas Laughren, in documents posted online, quoted the AP. The AP noted that Laughren referred to a recent New England Journal of Medicine article concerning the link between an increase in sudden heart death and antipsychotic use, and if Seroquel has “been shown to be acceptably safe for the treatment” of depression and anxiety, said the AP.
Meanwhile, AstraZeneca apparently buried a Seroquel study completed the same year the drug was approved over concerns about the report’s disappointing results. According to an earlier report by The Washington Post, Seroquel Study 15 found that patients gained 11 pounds a year on the drug, something that would have put them at an increased risk of diabetes.
Seroquel was introduced in 1997 and has long been linked to a risk of weight gain and diabetes. Information on this risk was originally included in the “Adverse Reactions” section of its label. In 2003, the FDA required AstraZeneca to give the information added prominence by moving it to the label’s “Warnings” section. Earlier this year, the label was updated to include data on children and adolescents, including blood-glucose levels, cholesterol, weight gain, and increased appetite.
Now, AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim it withheld information about Seroquel’s diabetes risk. Several states that have also sued AstraZeneca have charged it illegally promoted Seroquel for unapproved uses.
In 1999, AstraZeneca touted different data at an American Psychiatric Association conference and at a European meeting. According to an earlier Washington Post article, AstraZeneca maintained this data showed that Seroquel helped psychotic patients lose weight. The company-funded study AstraZeneca used to back that claim was conducted by a Chicago psychiatrist and internal documents reviewed by The Post indicate that AstraZeneca officials did not hold this doctor in high regard and had concerns he modified study protocols and failed to get informed consent from patients. They also wrote that they did not trust him with anything more complicated than chart reviews, the Post said.
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