Seroquel Link to Sudden Cardiac Death Cause For Concern

Concerns are mounting that Seroquel puts users at a higher risk of <"">sudden cardiac death. It was once thought that atypical antipsychotic drugs like Seroquel were generally safer than older, typical antipsychotic drugs. But a recent study in The New England Journal of Medicine (NEJM) casts significant doubt on this theory.

Seroquel was approved by the Food & Drug Administration Lock Up hd (FDA) in 1997 to treat schizophrenia. 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. For instance, these drugs have long been linked to a risk of weight gain and diabetes, and in 2003, the FDA required the makers of atypical antipsychotics to relabel 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.

In January 2009, the study on sudden cardiac death published in the NEJM raised even more concerns about Seroquel and other drugs in its class. For the study, scientists at the Vanderbilt University School of Medicine reviewed data on Tennessee Medicaid patients, comparing 44,218 people using older typical antipsychotics and 46,089 taking the newer atypical antipsychotics to 186,600 people who had never used the drugs.

Overall, people taking typical antipsychotics were at 1.99-times greater risk of sudden cardiac death, while the risk for those on atypical antipsychotics was increased 2.26 times. The increased risk was greater for people on higher doses of the drugs. People who had used the drugs in the past but stopped weren’t at greater risk of sudden cardiac death. The researchers concluded that atypical antipsychotics are not a safer alternative to typical antipsychotics in preventing death from sudden cardiac causes.

The association between sudden cardiac death and <"">Seroquel is especially disturbing given that it is frequently used off-label to treat elderly dementia patients, a group that already is more likely to suffer from heart problems.

Earlier this month, documents posted on the FDA website indicated that regulators were concerned about the association between Seroquel and sudden cardiac death. According to, the documents were released ahead of an FDA advisory panel meeting to consider expanding the approved uses of Seroquel XR (an extended release version of the drug) to include treatment of depression.

In one memo, the FDA’s director of psychiatry drugs said cardiac effects still raise questions about the drug’s safety. Other FDA documents noted the NEJM study, said.

The following week, the study was again cited when FDA advisers unanimously voted not to recommend that Seroquel be approved as a first-line treatment for depression. However, in a separate 6-to-3 vote, the panelists recommended that the medication could be used as supplemental treatment for patients with depression who do not get symptom relief from other drugs.

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