Seroquel Has a New Cousin, While Lawsuits Continue

Washington, DCSeroquel received approval from the US Food and Drug Administration (FDA) for two specific indications but was allegedly marketed by its manufacturer for a host of off-label uses. Now the antidepressant drug has a cousin. Late in 2009 the FDA granted approval to AstraZeneca for Seroquel XR, an add-on treatment for Major Depressive Disorder (MDD). Meanwhile, thousands of lawsuits are still pending with regard to Seroquel side effects.

Seroquel was approved by the FDA for schizophrenia and acute manic episodes associated with bipolar disorder. However, AstraZeneca has been accused of promoting the product off-label for the treatment of dementia (mostly in seniors), various anxiety disorders and to children under the age of 18.

Such off-label use has only heightened recognized Seroquel side effects, including unexplained weight gain, diabetes, tardive dyskinesia and hyperglycemia. Plaintiffs in various lawsuits pending against the manufacturer claim that Seroquel was marketed off-label in an effort to increase market share for a product that was restricted to a limited market at best, based upon the two indications for which it was initially approved by the FDA.

Now Seroquel and other antidepressant drugs face another setback. According to the January 6 edition of USA Today, a new study provides evidence that antidepressants may be no more effective than a sugar pill for the majority of people who take them.

Robert DeRubeis, a psychologist at the University of Pennsylvania, co-authored a small study that pooled data from six trials involving 718 depressed patients randomly assigned either an antidepressant or a placebo.

Antidepressants were more effective than a placebo only for patients with very severe depression, who made up 40% of trial participants, but who represent fewer than 30% of depressed people who seek treatment in the real world, according to a recent survey cited in DeRubeis' paper.

"The health establishment needs to take stock and ask about costs and benefits" of antidepressants, DeRubeis says.

FDA spokeswoman Karen Riley called DeRubeis' paper "useful."

"Every patient is different, and translating these findings into clinical practice is yet another challenge," Riley added. "Some modestly ill patients will still benefit from drug treatment, while some very severely ill patients will not."

A larger study published in February 2008 reached conclusions similar to those in DeRubeis' paper, which appeared in the January 6 issue of the Journal of the American Medical Association.