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TUESDAY, Aug. 19, 2003 (HealthDayNews) -- If drugs are going to be prescribed for children, they'll be safer and more effective if they're tested on kids, a new federal study suggests.
A voluntary government provision that gives pharmaceutical firms extended patents on their medications if they test them on children appears to be improving the safety of the drugs, according to the researchers at the Food and Drug Administration.
Their study finds that gearing clinical trials to kids -- which used to be a rare event -- has given regulators precious, if limited, knowledge about the way a handful of medications affect kids. And that information, including evidence of seizures linked to one drug, suicidal thoughts to another, and greater deaths with a third, has led to more appropriate labeling of some medications often given to kids.
The issue may be critical, experts say, because between half and three-quarters of all the drugs prescribed to children haven't been adequately tested in kids. Prescriptions are made "off label," that is, without direct approval from regulators, based on safety and effectiveness studies in adults.
That practice, while perhaps unavoidable, carries risks. A study last year in the journal Pediatrics found that almost 250 infants and toddlers may die every year from bad reactions to drugs and related therapies which the FDA can't require companies to test in children. And earlier this summer, the FDA said it would look into evidence that children and adolescents taking the antidepressant Paxil face an increased risk of suicide.
The FDA has tried to force drugmakers to use children for testing products that affect children. In 1998, the agency proposed the so-called "Pediatric Rule," which would have compelled drug makers to test their adult medications in children if they had a sizable pediatric market.
Three conservative groups, the Competitive Enterprise Institute, Consumer Alert and the Association of American Physicians and Surgeons, sued to block the regulation. And a federal court ruled last October that the agency has no authority to enforce the law. However, the U.S. Senate in June passed a bill that gives the agency the power; the bill now awaits a House vote.
But if the FDA lacks a stick, it has a carrot. In 1997, Congress empowered the agency to ask companies to conduct such studies in exchange for an additional six months of exclusive marketing rights without competition from generic knock-offs.
The latest study, which appears in the Aug. 20 issue of the Journal of the American Medical Association, looked at the effects of that law.
Between 1998 and 2001, the FDA asked firms to conduct studies of 242 drugs used in children. The agency got 53 assents, covering 33 medications. These included the anesthesia Versed, the arthritis drug Lodine, the behavior drug Luvox, the anxiety easer Buspar, and the antiviral therapy Rebetron, which combines two medications.
Twelve of the studies looked at safety alone, 23 looked at safety and effectiveness, and 18 looked at the way the drugs worked in the body. The studies led to "significant" new dose or safety information for 12 of the drugs.
As of January 2003, 49 drugs have been relabeled to include information on their effects in children, the researchers say. "The beneficial effects of studying drugs that are being prescribed to children include important dose changes, as well as improved safety information on how to more appropriately prescribe these drugs for the pediatric population," they write.
Dr. Peter Budetti, a physician and lawyer at the University of Oklahoma, says the study demonstrates that "when you use the carrot, you get such important information that it's clear that this system needs to move even more quickly."
Budetti, author of an editorial accompanying the journal article, says Americans are generally "shocked" to learn that doctors can prescribe -- and companies can sell -- drugs to children with no evidence of the drugs' effectiveness or safety. That reaction, he adds, could add some "moral suasion" to legislative pressure on drug makers to conduct studies of their products in children.
Pharmacist Sherry Luedtke, president of the Pediatric Pharmacy Advocacy Group in Amarillo, Tex., says the latest study shows how sorely the FDA needs the power to demand testing of drugs in children.
And while the research prompted by the patent extensions is valuable, Luedtke says, the medications studied aren't typically the most common drugs doctors prescribe to children.
The list "doesn't really make up the everyday stuff that you see," says Luedtke, who teaches at the Texas Tech School of Pharmacy.
More information
For more information about drug safety in children, try the FDA or the Pediatric Pharmacy Advocacy Group.
