diabetes Seroquel In The News

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<H1 class=Headline itxtvisited="1">Found this article in today's news as I know that Seroquel has been in the news lately and perhaps some of you might take it. I know that I used to, or at least the VA tried to make me take it until it made me very sick (I have a cardiac history; yet they gave me Seroquel!!); they still don't understand why I won't take it.....duh.

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Seroquel's Side Effects Too Much For Depression</H1><H2 class=SubHead itxtvisited="1">Worrisome Side Effects May Limit Schizophrenia Drug's Use</H2>MATTHEW PERRONE, AP Business WriterPosted: 2:52 pm EDT April 8, 2009Updated: 9:28 am EDT April 9, 2009

WASHINGTON -- Federal health experts said overwhelmingly Wednesday that the side effects of AstraZeneca's schizophrenia drug Seroquel are too worrisome to make it a first choice against depression.

However, the panel of Food and Drug Administration advisers also said the drug could be useful as a supplemental therapy for patients who are not finding relief with other antidepressant drugs.

Seroquel, which posted sales of $4.5 billion last year, is already approved to treat schizophrenia and bipolar disorder. Now the London-based drugmaker wants the FDA to approve it for patients with depression and anxiety disorder, a much larger population that includes more than 20 million U.S. patients.

But FDA regulators expressed concerns about allowing nearly 10 percent of the U.S. population to use a drug with side effects including weight gain, high blood sugar and potential heart problems.

Panelists voted unanimously that the drug was not safe enough for use as a first choice, stand-alone treatment of depression and anxiety disorder, given older, more established drugs.

"I saw no clear advantage demonstrated in efficacy," said Dr. Wayne Goodman, an NIH researcher who chaired the panel. "There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug."

But panelists voted 6 to 3 that the drug could be used as an added therapy for patients who are already taking therapy but aren't experiencing relief from depression. The panel did not hold a similar vote for anxiety disorder.

"In terms of balancing the risks and benefits I think this would be acceptable" as a second-line therapy, said Dr. Delbert Robinson, a psychiatrist at Zucker Hillside Hospital.

FDA is not required to follow the advice of its panels, though it usually does.

Seroquel is part of a new generation of psychiatric medications, called atypical antipsychotics, thought to be safer than older medications. But a paper published in the New England Journal of Medicine earlier this year found that patients taking newer medications have the same likelihood of dying of a sudden heart problem. The study from researchers at the Vanderbilt University found there were about three deaths per year for every 1,000 patients taking older or newer antipsychotics.

"Our study provides evidence that this drug may produce a side effect that is of extreme concern to patients," said Vanderbilt's Dr. Wayne Ray, who was invited by the FDA to present his findings.

Many physicians already prescribe Seroquel and other antipsychotic medications to manage depression and anxiety. But FDA approval would allow AstraZeneca to market its powerful antipsychotic for those uses.

The company said there is a significant need for new depression treatments, pointing out that the disease returns in a third of patients treated with existing antidepressants. Many patients stop using the drugs due to side effects like insomnia, sweating and decreased sex drive.

Largely absent from the panel's discussion was the ongoing debate about Seroquel's possible role in contributing to diabetes, a controversy that has generated thousands of lawsuits against AstraZeneca in recent years.

However, more than a dozen members of the public -- including spouses of patients who died while taking the drug -- called on the FDA panel to deny approval of Seroquel for depression, with many citing its metabolic side effects.

"It is your job to keep Seroquel off the market for this expanded use unless the company can conclusively prove that it does not increase the risk of diabetes," said Dr. Diana Zuckerman of the National Research Center for Women and Families.

Lawyers representing some 15,000 former Seroquel users claim AstraZeneca knew nearly a decade ago that the drug caused diabetes, but kept that information secret.

A brief released by the plaintiffs attorneys Wednesday morning claims that internal AstraZeneca memos and data show Seroquel is both risky and not very effective.

One study showed Seroquel was not effective against depression but a comparator drug was. Several other studies of Seroquel failed to prove that depression symptoms stopped or waned significantly by six weeks, according to the brief.

AstraZeneca representatives said six of seven studies of Seroquel in depression patients and all four in anxiety patients showed it was effective. The company also disputed the level of side effects claimed by lawyers for the plaintiffs.

"The briefing document ... is lawyers practicing medicine," said Arthur Brown, an outside lawyer working for AstraZeneca.