Personal Injury Law

FDA Considers Atyical Anti-Psychotics For Children, Teens

By Jane Akre

FDA Considers Psychiatric Drugs For Kids

Advisors to the Food and Drug Administration (FDA) on Wednesday will consider whether powerful psychiatric drugs should be used in children, despite the dangers.

The drugs in question treat schizophrenia and bipolar disorder.

AstraZeneca and Lilly want to market Seroquel and Zyprexa for adolescents to treat manic depressive disorder and Pfizer wants its drug, Geodon to be used for adolescent and teenage bipolar patients in ages 10 to 17. Currently only Bristol-Myers Squibb's Abilify and Johnson & Johnson's Risperdal have approval for use in younger patients

Representatives from each company presented data on the efficacy and safety of their drugs at a Tuesday panel meeting in Washington.  In 2008, that class of blockbuster drugs accounted for $14.6 billion in sales.

The FDA usually follows the recommendations of its advisory panels, though it is not required to, and the head of the division overseeing psychiatric drugs indicated a favorable review Tuesday.

"We generally are in agreement that the sponsors (the makers of Seroquel, Geodon, and Zyprexa) have provided adequate support to suggest effectiveness for treating those conditions in children and adults," said Thomas Laughren, director of the FDA's Division of Psychiatry Products, in a memo.

Last November, an expert panel said the long-term effects of prescribing anti-psychotics to children needs more study.

The Downside

The side effect from these risky drugs can be an increase in the risk of diabetes, weight gain, high blood sugar, and sleepiness.

Consumer organizations from Consumers Union, and the Patient and Consumer Coalition, among others, are urging more in-depth testing to look at the long-term effects of drugs in this class of atypical anti-psychotics.

Already, doctors are prescribing the three anti-psychotics to about a million American teens every year. 

William Cooper, a professor pediatrics at Vanderbilt University says his national survey finds the number of prescriptions written to children nationwide has increased over five times in the last seven years, NPR reports. Ironically, another study found the incidence of bipolar disorder diagnosed in children has increased 40 times.

Diana Zuckerman of the National Research Center for Women & Families tells USA Today, "Unfortunately, the studies are inadequate. They provide really no useful information about the long-term risks of tardive dyskinesia, sudden death or diabetes."

Lisa Ortiz of Austin, Texas told the expert panel Tuesday that Seroquel killed her 13-year-old son four days after it was prescribed.

Even David Fassler of the American Psychiatric Association told the panel, "We don't have sufficient data on long-term safety and efficacy in pediatric populations." He believes if approved, the anti-psychotics should only be used for short-term or on-again, off-again use.

Still other parents testified that the atypical anti-psychotics have allowed their children to function almost as normal children.

Background

Among a second generation of antipsychotics, Zyprexa was an  "atypical" antipsychotic wonder drug developed in the 1990's and thought to be a silver bullet in the battle against severe mental illness because it didn't cause the tremors and facial tics of other drugs.   

Atypical antipsychotics were more expensive but much heralded and with an intense marketing campaign, Zyprexa and other atypicals were increasingly prescribed by doctors for all sorts of mental health issues including "off label" to treat depression and anxiety.

But there were the downsides. Zyprexa caused serious weight gain and diabetes among patients who had no history of diabetes before taking it. 

In 2003, the FDA ordered warning labels on all atypicals concerning the increased risk of diabetes. 

Internal Eli Lilly documents showed that 16 percent of patients on Zyprexa gained more than 66 pounds after taking the drug for a year, a figure higher than what Lilly revealed publicly. 

In a St. Petersburg Times article, a sales rep says he was told to tell doctors that patients should drink a glass of water before they eat to suppress appetite to fight the weight gain.

The reps pitch was "Would you rather have a skinny, unwell patient or a fat, stable one?"

Ultimately some 30,000 patients sued the maker for these undisclosed side effects and Eli Lilly paid out more than $1-billion to settle the cases.

The benefit of the original antipsychotics are their cost - about $100 a month compared to $300 to $500 a month for the newer class of atypical anti-psychotics.  #

Full post as published by InjuryBoard on June 10, 2009 (boomark / email).