October 09, 2009

AstraZeneca Defends Seroquel Weight Gain Warnings

It's always flattering in a weird way to know that various pharma companies follow this website--AZ, Lilly, BMS, J&J, Wyeth and so on all pop in from time to time--and yesterday I got an email from Tony Jewell, a spokesman for AstraZeneca. He was responding to a post I wrote yesterday regarding AZ casting Seroquel as a "weight neutral" drug in the early years of this decade when the company had knowledge that some patients were packing on the pounds.

"Re the post below, it is important to remember that since 1997, when Seroquel was first approved, labeling has alerted physicians that 'diabetes mellitus,' 'hyperglycemia' and 'weight gain' had been observed in clinical trials. We have continued to update the label on these topics as the science has developed."

I don't know what the 2001 package insert or the 2004 insert (the year I began taking the drug) said on the matter of weight gain, but weight gain is pretty prominently featured in the current PI under "warnings and precautions" and the percent of people gaining more than 7 percent of body weight (indicator of diabetes risk) is outlined from various clinical trials.

I'm pretty damn certain that such information wasn't in the PI in 2004 or my doctor would have alerted me about weight gain issues or I would've found the information myself. I doubt that the weight gain warnings were as prominent in 2004. I wish AZ had been more upfront at the time, as it would've saved me much trouble (not to mention tardive dyskinesia, nightmares and muscle tightening. Yes, Tony, I experienced neuroleptic malignant syndrome on Seroquel).

More to the point, however, AZ was clearly telling its sales force to tell doctors that Seroquel was weight neutral, so the fact that there was a stray notice of some kind in the PI circa 2004 about weight gain is almost meaningless.

Jim Edwards at bnet.com had some fun with AZ's weight neutral claims yesterday.

Posted by Philip Dawdy at October 9, 2009 12:03 AM
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Comments

Phillip, I think you put way too much faith in your doctor.

I hate to say it but The 1/12/2004 Label has pretty extensive warnings that were easy to find and understand in comparison to some newer labels. Weight gain was mentioned 10 times.

NMS, Tardive D..., Hyperglycemia and Diabetes Mellitus, Cataracts, Seizures, Hypothyroidism, Cholesterol and Triglyceride Elevations, Hyperprolactinemia, Orthostatic Hypotension, Esophageal dysmotility and aspiration and Impairment of Fertility, just to name a few (and I haven't even read the "adverse reactions" section yet).

“Weight Gain: In schizophrenia trials the proportions of patients meeting a weight gain criterion of >7% of body weight were compared in a pool of four 3- to 6-week placebo-controlled clinical trials, revealing a statistically significantly greater incidence of weight gain for SEROQUEL (23%) compared to placebo (6%). In mania monotherapy trials the proportions of patients meeting the same weight gain criterion were 21% compared to 7% for placebo and in mania adjunct trials the proportion of patients meeting the same weight criterion were 13% compared to 4% for placebo”.

The warnings are wrapped up in B***S*** like, “Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population”, etc.

As someone who doesn’t have a medical education (or education beyond high school), I can still easily figure out that; Three, 3 week trials for Bipolar and three 6 week trials for schizophrenia are extremely short trials and with all these warnings, these drugs are going to ruin peoples health and lives. If I can see through the B***S***, having 13 years of brain damage, an MD can see through it too.

I think it’s time the “learned intermediaries” are held accountable for ignoring these labels that patients don’t read because they trust their doctors to “first do no harm”.

AZ couldn't sell their poisons without doctor's. And I can't get my head around the idea that doctor's are ignorant, or don't have enough time to do their jobs, or the healthcare insurance system is at fault.

Posted by: Damaged at October 9, 2009 07:08 AM

TD and stiff muscles aren't the same thing as NMS, are they? I thought NMS was life-threatening, whereas the other two are "merely" horrendous. Please clarify if you can.

Posted by: Miranda at October 9, 2009 07:52 AM

TD and stiff muscles are not the same thing as Neuroleptic Malignant Syndrome. NMS is an acute life threatening disorder characterized by high fever, confusion, elevated CPK(muscle enzymes), severe muscle rigidity and elevated white blood cell count. It is rare and impossible to predict. Tx involves supportive care, IV fluids and watching for acute renal failure. Tardive Dyskinesia is an involuntary movement disorder caused by the use of anti-psychotics and other dopamine antagonists. It often involves movements of the mouth and face.

Posted by: John Sorboro MD at October 9, 2009 10:02 AM

I think it is amazing how all these psych drugs seem to be prescribed with no concern as to their physical side effects. It's almost as if one's physical health is somehow unimportant, as long as "mental health" issues are "treated". Maybe psychiatrists and "regular" MDs ought to work together to develop treatment plans that are good for both body and mind instead of each practitioner focusing on a separate area and seemingly not talking to one another.

Posted by: Aaron at October 10, 2009 05:52 PM
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