Friday, November 06, 2009

The "Business" of Drugs: Massive Weight Gain for Children on Antipsychotic Drugs Added to the Growing Side Effect List

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Dear Members,

The Wall Street Journal released a new study published in the Journal of the American Medical Association today, which noted that antipsychotic drugs, widely used in children, actually caused them to gain as much as 19 pounds on average after just 11 weeks on the medications.

And while weight gain can sometimes be seen as a relatively minor side effect – especially when compared to increased and even murderous aggression or the often reported suicidal tendency these exact drugs bring to adults and youth alike, the report noted the drugs propensity to cause the type of significant weight gain that could lead to diabetes and cardiovascular (heart) disease.

Known as the atypical antipsychotics, the direct correlation to significant weight gain adds to growing concerns about giving the medicines to patients under 18 years of age. The study's authors urged child psychiatrists to exercise more caution before deciding to prescribe, and recommends close monitoring of patients who do wind up taking these “wonder” drugs.

These powerful drugs are used to treat schizophrenia and bipolar disorder, but have faced growing scrutiny, not only because of proven side effect risks, but also because of the aggressive and often illegal re-marketing tactics by their makers that have helped make them the highest-selling class of drugs in the U.S.

The study results were fortuitously released in advance of Food and Drug Administration’s likely official authorization of these drugs for even younger patients. Atypical antipsychotics already have limited approval for youths, but doctors have been “free to prescribe them as they see fit” without any FDA authorization to do so and unfortunately they often give them to children and adolescents, say analysts and psychiatrists

Psychiatrists turned to the new drugs after they began going on sale in the 1990s because they didn't cause involuntary facial tics and other visually obvious cosmetic type problems that an earlier generation of these types of medicines did. Last year, the drugs collectively generated $14.6 billion in sales in the U.S., but a growing number of studies confirm that these new drugs have their own set of significant, yet often ignored, side effects.

"The weight gain is much larger than we thought," said Christoph Correll, the study's lead author, who is a psychiatrist and a scientist at the Feinstein Institute for Medical Research in Manhasset, N.Y. "It's massive, and it's the medication" that caused it, he said.

The JAMA study, conducted in 272 youths ages 4 to 19 years, is the largest and most definitive to date to establish a link between the drugs and weight gain, the authors said. Unlike earlier studies, it looked only at patients who hadn't previously taken the medicines.

The drugs examined were four top-selling atypical antipsychotics: Abilify, sold by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.; Risperdal from Johnson & Johnson; Seroquel from AstraZeneca PLC; and Zyprexa from Eli Lilly & Co.

Interestingly, the study found that, of the drugs studied, Zyprexa caused the most weight gain. Over 11 weeks of use, children on Zyprexa gained the most weight on average, nearly 19 pounds, or a 15% increase. The Zyprexa drug was also found to significantly raise levels of blood sugar, cholesterol, insulin and triglycerides, which can lead to diabetes and heart problems.

Patients taking the other three drugs gained from 10 to 13 pounds on average, according to the study and the negative impact on users' blood sugar and other metabolic levels varied, depending on the drug.

In January, Lilly agreed to pay $1.42 billion to settle a federal probe into alleged improper re-marketing of Zyprexa. Other pharmaceutical companies have also come under fire for allegedly promoting off-label uses of atypical antipsychotics and playing down or withholding information on their adverse side effects.

Fortunately, as concerns about the side effects have mounted, prescriptions for children have slowed down. Dr. Correll encouraged child psychiatrists to be even more careful about giving the drugs to youths and, when they do, to encourage a healthy diet and to check weight and metabolic levels every three months.

The FDA will soon decide whether to approve younger patients' use of Seroquel, Zyprexa and Geodon, another atypical antipsychotic. (note: Geodon wasn't part of the study because, until now it's not often used in new patients and too few users were even enrolled in the trials according to Dr. Corell).

You can call the FDA and let them know your thoughts about whether they should authorize any of these antipsychotic products to be remarketed to children in light of recent revelations. You can also suggest more in-depth trials be conducted to determine additional side effect risks.

Call 1-888-463-6332) Press 2, followed by 1 for information, then select #3 for drug products in order to log your complaint and/or suggestions.

You can also write to the Wall Street Journal reported who wrote this story to thank him for releasing this information in advance of any FDA approval to remarket these powerful drugs to children. We do not recommend promotion of any kind however, you can suggest related issues and possible follow up stories. The reporter is Jonathan Rockoff and he can be reached by email at Jonathan.Rockoff@wsj.com

 

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