April 03, 2009

FDA Publicly Worries About Seroquel's Risks

Today the FDA released briefing documents for next week's psychopharmacology advisory committee hearing on whether to approve Seroquel for three depression indications and generalized anxiety. In the documents, the FDA psychiatry products chief stated:

"'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. Laughren also pointed to a recent New England Journal of Medicine article that suggests antipsychotic drugs like Seroquel can increase the risk of sudden cardiac death.

"Specifically, the FDA will ask its panel to vote on whether the drug has 'been shown to be acceptably safe for the treatment' of depression and anxiety.

"The agency is not required to follow the advice of its panel, though it usually does."

According to the AP, the FDA found the drug efficacious for treating depression, but made no mention of any FDA finding on anxiety. AstraZeneca has kindly posted the briefing documents online here. They are very extensive, so only download them if you want all the technical details.

I encourage the committee to not recommend approval of Seroquel for any of the proposed depression and anxiety indications. It's a nasty drug and shouldn't be put into even wider use in the US.

Posted by Philip Dawdy at April 3, 2009 04:05 PM
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Comments

Do they ever consider how PCP's are already dosing this stuff out for insomnia, anxiety and depression?

Do they ever consider all of the psychiatrists who rx this out to children? Seroquel or XR who cares it's the same thing!

They need to stop allowing PCP's to prescribe with reckless abandon any psych meds to begin with, and then they need to take a look at why Abilify and Risperdal are approved for kids and also, why Laughren was on board with CABF and the pediatric bipolar pharma funded study.

The FDA is not a public health and safety entity, and this stuff is already approved in EU so it's just a matter of time here.

How they can ignore one thing and pay attention to the other is beyond me.

Posted by: Stephany at April 3, 2009 07:06 PM

Stephany poses a critical question: Are the majority of U.S. primary care physicians proficient in diagnosing and treating mental disorders? With regard to Seroquel XR, what is the probability of burst release and dose dependent toxicity (assuming that all tablets are manufactured uniformly)? Here is a description of the drug release properties for Seroquel XR:
http://www.kem.edu/dept/clinical_pharmacology/ACCP_Day1/Session%202/Dr.%20Rajeev-%20Oral%20Controlled%20Release%20Drug.pdf

Posted by: Nancy at April 3, 2009 10:37 PM

Seroquel was recently mentioned in a Miami Herald article detailing all the ailments, and all the prescription meds, that could get you turned down for individual health insurance:

"Trying to buy health insurance on your own and have gallstones? You'll automatically be denied coverage. Rheumatoid arthritis? Automatic denial. Severe acne? Probably denied. Do you take metformin, a popular drug for diabetes? Denied. Use the anti-clotting drug Plavix or Seroquel, prescribed for anti-psychotic or sleep problems? Forget about it."

Amazing how Seroquel is breezily acknouledged as a widely-used "insomnia" remedy. My question: Does a Seroquel script for sleep on your medical records get you turned down because of the high price of Seroquel? Or because of the high incidence of serious health problems among those who take it? Or both?

Posted by: Johanna at April 4, 2009 01:05 PM

I got Seroquel samples from a PCP for insomnia in 2006!

Posted by: Stephany at April 4, 2009 04:18 PM

A brief draft agenda for the meeting is posted here:
http://www.fda.gov/ohrms/dockets/ac/09/agenda/2009-4424a2-FDA-draft.pdf

Posted by: Nancy at April 5, 2009 03:09 PM

I will be recommending removal of both Seroquel in all its forms and ditto Zyprexa - from the market, based on existing evidence and documentation. Also the pressing of criminal charges of manslaughter for both based on existing evidence and documentation. And remarking that I will urge the President to establish a billion dollar DRUG investigatory task force, in addition to the FOOD investigatory task force that he already established. The D part of the FDA needs to be demolished and something that actually guards the PUBLIC HEALTH needs to be put in its place. I will be asking this in memory of all the innocents who have died from these two classes of drugs - on which there are now reams of info. -

Posted by: Anon. at April 5, 2009 06:26 PM

Oh Yeah those kind souls over at the FDA are looking out for you alright.

Is this why this committee is full of former AZ paid spokes persons and seroquel pushers including the chair.

AZ and other Pharma corps have stacked the deck against the American public; and bought and paid for the FDA and key government insiders from top to bottom.

They haven't listened to reason, answered questions, or allowed concerned voices to be heard; because they are to busy doing promotion gigs for the drugs industry and cashing those checks at the bank.

They have buried more bad data, poor studies, questionable research, and eye opening reports than AZ, Merk, and Lilly combined.

The FDA is just nothing more than a cheap drug industry whore at this point in our history.

So that leaves us unable to trust the drug industry, any of the research and studies, the doctors from sea to shining sea who have either taken the bait (as in accepting huge pay outs to sponsor and promote bad drugs) or have just bought into the lies, and then of course there is our government who allows this immoral and unethical behavior to continue at the FDA.

Don't believe me please; do your own research, reading, and decide for yourself! The evidence is now out there. Weigh it against what your hearing from the FDA.

We each have a voice that must speak out before any change begins to happen or take shape.

Posted by: FDA SAYS WHAT at April 5, 2009 06:41 PM

i took this drug for 2.5 yrs..i never got to get over 100 mgs a night of it.due to the sedative effects..after being on it 2.5 yrs my sugar went way up and so i got tachycardia from serquil also..140 bpm at rest..was in the e.r. 6 hrs..but its used among other things besides bipolar..off ;lable like for sleeping and opiate withdralws,anxitys,insomnia..all doc,s are prescribing this med and alot of people are getting high sugar counts obese..my observation of taking this drug only..thanks

Posted by: james at April 11, 2009 06:51 PM
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