FDA Panel Recommends Antipsychotic Drug Approvals for Children

An FDA advisory panel recommended this week that Seroquel, Zyprexa and Geodon should be approved for use among adolescents, despite concerns that side effects of the antipsychotic drugs may expose children to life-long health disorders.

The panel of outside experts voted to recommend that the FDA allow the manufacturers to market the medications to children, even though consumer groups, FDA staffers and some panel members expressed concerns over a lack of research into the long-term effects of the drugs, which have been linked to weight gain, increasing blood sugar and diabetes.

Eli Lilly and Co.’s Zyprexa, AstraZeneca’s Seroquel, and Pfizer’s Geodon are already approved for adult use for the treatment of schizophrenia and bipolar disorder, and many doctors already prescribe them off-label for children.

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Although doctors are free to prescribed approved medications for non-approved uses, the drug makers are not permitted to specifically market the drugs for use among children and teenagers until after the FDA has determined that they are to be safe and effective for adolescents.

The FDA is not required to follow the recommendations of their advisory panels, but they usually do. Currently, only Johnson & Johnson’s Risperdal and Bristol-Myers’ Abilify have approval as antipsychotic drugs for children.

Atypical antipsychotic medications became the top-selling class of drugs last year, raking in $14.6 billion in sales, according to IMS Health Inc.

Zyprexa, Geodon and Seroquel side effects can include weight gain, high blood sugar, and increased risk of diabetes. Critics of the plan to market the drugs toward children say that the drugs treat disorders that are likely to require treatment for life, so long-term studies need to be conducted to see if the known health risks are increased over time, or if new health risks arise.

A report released by FDA researchers in advance of the panel’s hearing noted particular concern about the length of time youths would be on the medications.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of the possible effects on growth and development,” the report said.

Some panel members echoed these concerns at the hearing held Tuesday. Half of the panel abstained from the Geodon vote, which passed 8-1, citing concerns that data from the company was incomplete.

Potential problems with antipsychotics have already lead to thousands of lawsuits against AstraZeneca and Eli Liilly over side effects of Seroquel and Zyprexa respectively.

Eli Lilly has paid more than $2.5 billion settling Zyprexa lawsuits filed by individuals and the government, including charges that they engaged in illegal marketing practices that encouraged off-label use.

AstraZeneca currently faces more than 9,000 Seroquel lawsuits from consumers who allege that they developed diabetes, pancreatits, a rare movement disorder known as tardive dykinesia, as well as other injuries.

5 Comments

  • L JinniesMay 25, 2010 at 6:38 pm

    I took Geodon for years, when I got pregnant I quit taking the medicine. 7 months later, I collapsed of heart failure. I later read one of the side effects of this medication is irregular heart rythm, which is why I had to have an ICD placed in my heart.

  • Daniel HaszardJuly 8, 2009 at 3:03 pm

    Eli Lilly Zyprexa can cause diabetes I took Zyprexa a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes. This is a powerful drug that can damage a young person physiologically for life. Please take with caution and learn as much as you can about side effects. Eli Lilly's #1 cash cow Zypr[Show More]Eli Lilly Zyprexa can cause diabetes I took Zyprexa a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes. This is a powerful drug that can damage a young person physiologically for life. Please take with caution and learn as much as you can about side effects. Eli Lilly's #1 cash cow Zyprexa drug sale $38 billion dollars so far,has a ten times greater risk of causing type 2 diabetes over the non-user of Zyprexa. So,here we have a conflict of interest that this same company also is a big profiteer of diabetes treatment. Daniel Haszard

  • maryJuly 6, 2009 at 4:45 pm

    my grandson is on drugs now being 3years. He continuely is getting worse. It is very hard on my daughter who works 2jobs to take care of her children alone. S omething must be done to save our next generation .

  • sethJune 14, 2009 at 11:31 am

    I hope that this civilization wakes up and notices that these drug companies claims to help "US" is actually destroying our cultures future. The use of their dangerous antipsychotic drugs on our children and adults is absurd. If a person needs mental help give that person help not a drug that does'nt even pertain to their system. Does anybody think that just maybe if a person who had depression w[Show More]I hope that this civilization wakes up and notices that these drug companies claims to help "US" is actually destroying our cultures future. The use of their dangerous antipsychotic drugs on our children and adults is absurd. If a person needs mental help give that person help not a drug that does'nt even pertain to their system. Does anybody think that just maybe if a person who had depression was actually handeled and found out why they are depressed would actually move on in life and once again be a happy and contributing member of society again. Drugs that just treat symptoms and not the cause are just a lazy mans way of an actual human being standing up and taking responsibility for man kind. A strong hand is what is actually needed to reach out and pick up mankind up off the ground .I think we our all worth it, don't you?

  • j cuddyJune 13, 2009 at 12:33 pm

    I wonder if the "advisory panel" (a) would take the drug themselves for testing or better yet (b) give it to their own children to test. The insanity of prescribing these drugs to not only adults but children will further create a society that is not only dumbed down but one that is zoned out to what is occurring in the world. We should all ask ourselves how do we truly want to care for our ki[Show More]I wonder if the "advisory panel" (a) would take the drug themselves for testing or better yet (b) give it to their own children to test. The insanity of prescribing these drugs to not only adults but children will further create a society that is not only dumbed down but one that is zoned out to what is occurring in the world. We should all ask ourselves how do we truly want to care for our kids and what legacy do we want to leave them. A drugged society is not what I want to create and recommendations likes these foster not only the drug companies stuffing their coffers with money but makes a statement that we believe drugging our kids is acceptable behavior based on little factual scientific data. It's a disgrace to all of us.

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