More drugs in development for pediatric use
Timentin recently cleared for use in children
Pediatric drug labeling is on the rise, thanks to recent legislation and proposed U.S. Food and Drug Administration regulations, but more needs to be done, experts say. Only about 20% of approved drugs include information in their labeling about use in children. That means physicians have to rely on information in the literature - perhaps a single uncontrolled trial - to make their prescribing decisions. And that can result in less than adequate care.
For example, 95% of drugs administered to newborns have not been labeled for use in such young patients, says Robert Ward, MD, professor of pediatrics at the University of Utah in Salt Lake City and chairman of the American Academy of Pediatrics' Committee on Drugs. "It doesn't mean they haven't been studied at all, but it means the studies are small in number and limited in scope, so they're not going to address all the issues needed to obtain labeling," he says. "But you have to go on and practice medicine just the same."
But Ward says the situation should improve dramatically in the wake of the passage of the FDA Modernization and Accountability Act of 1997. One provision of the act allows for six months of market exclusivity - translating into hundreds of millions of dollars saved by drug companies - to selected new and already-marketed drugs for which pediatric studies are done. The law also requires the development of a prioritized list of drugs for which additional pediatric information is needed. Also on the horizon are proposed FDA regulations that would require drug manufacturers to provide safety and effectiveness data on pediatric populations for selected drugs. Ward and other advocates want that requirement to apply to all drugs that treat a condition that occurs in children.
"The legislation is the carrot, and the regulations are the stick," Ward says. "We hope the two together will provide a pretty strong stimulus for pediatric studies."
The FDA hopes the proposed regulations will be finalized by the end of the year, says Khyati Roberts, FDA science policy analyst.
Ward isn't so sure the regulations will ever be final, but he says the threat of them plus the reward in last year's FDA act is already stirring activity. Some drug companies are trying to close the gap in such areas as HIV infection, cancer, and asthma. Examples of drugs in development for pediatric use include Crixivan and Viramune, already marketed for HIV infection and AIDS in adults, as well as Accolate and Flovent Rotadisk (see Disease Statement Management, February 1998) for treatment of asthma.
Timentin used in pediatrics
Another good example of a drug recently labeled for pediatric use is Timentin, a very effective antibiotic combination that treats a wide range of bacterial infections, says Michael Reed, PharmD, professor of pediatrics at the Case Western Reserve University School of Medicine and Rainbow Babies and Children's Hospital in Cleveland. More than 700 children with various infections, including respiratory, bone and joint, skin, urinary, and gynecologic, were studied.
The drug was found to be well-tolerated and was approved by the FDA for use in children over three months old. Timentin, composed in part of the beta-lactam antibiotic ticarcillin, is designed to overcome a mechanism by which several important bacterial pathogens become resistant to therapy. Adverse reactions, similar to any penicillin, include skin rash, headache, and gastrointestinal disturbances. The drug is not indicated for treatment of septicemia or infections caused by Haemophilus influenza type B.
"Timentin is very effective and has a highly desirable safety profile," Reed says. "This drug has been used in children before, but there were no optimal dose recommendations. Any drug used in children should have official labeling."
Reed says physicians have no choice but to use certain medications in children, even if they aren't labeled that way. "The physician will use a drug if it's in the patient's best interest. The problem is they may not know at what dose the best results will be achieved."
[For more information on pediatric drug labeling, contact the government office of the American Academy of Pediatrics, 601 Thirteenth St. NW, Suite 400 North, Washington, DC 20005. Telephone: (800) 336-5475. Robert Ward, MD, chair of the AAP Committee on Drugs. Telephone: (801) 581-7052. Khyati Roberts, science policy analyst, U.S. Food and Drug Administration, (301) 594-5470. Michael Reed, MD, Rainbow Babies and Children's Hospital, Pediatric Pharmaceutical Division, 11100 Euclid Ave., Cleveland, OH 44106-6010. Telephone: (216) 844-4525. For more information on Timentin, contact SmithKline Beecham at (800) 366-8900, ext. 5231.]
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