Zypreza, Seroquel Side Effects in Children Need Further Review: FDA Staff

According to documents released Friday, FDA staff members say that the agency needs to conduct more of an in-depth investigation into the metabolic side effects for children using Seroquel, Zyprexa and other newer atypical antipsychotics, which could lead to weight gain, diabetes and other serious health problems.

Reviewers from the FDA’s pharmacovigilance division warned the agency that there needs to be more study into Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel side effects on children. However, on the same day, AstraZeneca announced that the FDA approved the use of Seroquel in children ages 13 to 17.

The Division of Pharmacovigilance (DPV) report was originally written in October, however it was only released last week. The division was asked to do a safety review of a number of antipsychotics and how they affect teenagers in November 2008 by an FDA advisory committee. FDA staff looked at a number of drugs, including Seroquel and Zyprexa, as well as Johnson & Johnson’s Risperdal, Pfizer’s Geodon and Bristol-Meyers Squibb’s Abilify.

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The report warns that the adverse events reporting system relied on by the FDA to alert the agency for potential problems manifesting in approved products is not exacting enough to accurately detect and quantify potential problems with the antipsychotics. Reviewers pointed to a study released in October in the children on Zyprexa and Seroquel showed signs of rapid and dramatic weight gain and said that more studies need to be conducted into the metabolic effects of those and similar drugs.

Seroquel (quetiapine fumarate) is one of the more widely used atypical-antipsychotic, generating nearly $4.45 billion in annual sales for AstraZeneca. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide. In addition to its approval for use in teens, the FDA also approved the use of Seroquel XR as an add-on treatment for major depressive disorder.

AstraZeneca faces thousands of Seroquel lawsuits that allege the company failed to adequately warn about the risk of weight gain, which caused users to develop diabetes and other serious health conditions. Although internal documents produced during the Seroquel litigation suggest that the company was aware of the Seroquel diabetes problems, the drug maker continues to fight the cases and has spent over $600 million in defense costs before the first case has gone to trial. All federal Seroquel cases have been consolidated in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.

Eli Lilly has also faced legal a number of legal claims over side effects of Zyprexa. The drug maker has already paid over $2.5 billion to settle individual and government Zyprexa lawsuits for failing to adequately disclose the risk of diabetes and weight gain. They have been accused of fraudulent marketing of the drug for uses that they had not established were safe or effective.

4 Comments

  • jenJune 23, 2011 at 2:05 am

    its so funny that i see this post today. two of my children have been on abilify. for my daughter it was disastrous. she gained 80lbs in ten months. she has awful stretch marks all over her body now. i took her off. within a few weeks her behavior changed for the better. i feel abilify also affected her behavior in a way in which we thought it was her symptoms worsening. all along it was this medi[Show More]its so funny that i see this post today. two of my children have been on abilify. for my daughter it was disastrous. she gained 80lbs in ten months. she has awful stretch marks all over her body now. i took her off. within a few weeks her behavior changed for the better. i feel abilify also affected her behavior in a way in which we thought it was her symptoms worsening. all along it was this medicine. now my son has also been on it for 5 years.since the age of six. since my daughter has improved without the medicine i thought i would give it a try since it was for his adhd and summer vacation and all. i just mentioned today that since he has not been on the meds i dont think he has had an accident in his pants. yews he is eleven. but he claims he didnt know it was happening and the doctor would look at me like im nuts. now i read the other posts that other children have had accidents while on this medicine. im so glad to know why he was having accidents, and happy to report his mood swings are almost gone in just a little more than a week. yes it was rough the first couple days, but im seeing a new child, who hasnt had a bathroom issue. abilify has ruined a few years of our families life, i hope we can heal from all the damage it has caused. i would like to suggest that unless your child has serious mental disabilities, talk to your doctor about removing your child from this medicine just for a trial and see if your child improves after the initial withdrawal. of course do check with the doctor first, as i am not a doctor and cannot give out medical advice. but i have seen what i thought was my kids behaviors worsening turns out to be abilify causing it in the first place, and many more side effects i didnt realize. some people may be helped by abilify and may need the meds, but i feel my children was guinea pigs testing and i dint know it.

  • susanJune 14, 2011 at 2:52 pm

    April~ my son started having bathroom accidents after being on Abilify for 1 month. he stopped taking it 5 months ago and is still having issues. before Abilify he had no medical issues and all the tests he's had done have shown no medical link to these accidents. have you had any luck in linking the two?

  • joshOctober 28, 2010 at 10:03 pm

    hi im a seventeen year old boy so what im about to say might not mean much, but when i was 15 they said i had an anger problem and had me on abilify lovan and risperdal, i felt like my emotions where numbed out and i had no push and go, i was just docile all the time, what ever is going on with your daughter is defently the abilify with out a doubt

  • AprilOctober 1, 2010 at 6:29 pm

    My daughter was on Abilify since she was 5 years old. She took the drug for 3 years and is now 8. She seems to have mucle controll loss and has bathroom accidents constantly. I am working with doctors to link the Abilify to this problem since it occured after she started the medicine. She was diagnosed with an anger disorder by a doctor which then perscribed Abilify.

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