Pediatric Drug Safety: Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Wendy Goldberg knows first-hand the frustrations of treating her child with drugs made in tablet form for adults. "I need to cut two of them in half," she told the panelists at the hearing preceding the rule. One, she said, is "like a little stone. I got a gadget from my pharmacist that is supposed to cut it in half, but it doesn't work exactly right. Do I give her the big 'half' or the small 'half'? I usually give her the big piece in the morning, on the theory that if something bad happens, at least she'll be awake."

Controlled Risk

To those who point out that bad things can happen during drug studies, too, the American Academy of Pediatrics has responded that treating children with untested drugs may place more kids at risk than including them in controlled studies of the drugs in the first place.

Children enrolled in drug studies "are sick children that stand to benefit from getting new drugs sooner," says AAP's Ward. "Yes, they will be at risk, just like adults are at risk, if the drug is later found to have problems. But because we're treating children with illnesses, that risk is justified."

Under the rule, the timing of studies in children will depend on the seriousness of the disease, the availability of other treatments, the amount of safety and effectiveness information already available, and the types of studies that are needed.

FDA will not delay the approval of a drug for adults to await completion of children's studies. Instead, the agency could approve the drug for adults on the condition that the company completes pediatric studies in a timely way.

The pediatric study requirement may be waived entirely if a drug is not medically important for children and will not be commonly used in children or if:

• there is strong evidence that the drug product would be ineffective or unsafe in all pediatric patients or
• children's studies are impossible or highly impractical because, for example, the number of patients is too small or geographically spread-out or
• attempts to develop a pediatric formulation have failed.

The Pediatric AIDS Foundation's Westmoreland is confident that "virtually all" drugs with significance to children will be studied because of the new FDA rule, as well as the complementary financial incentives under the FDA Modernization Act of 1997, which gives an extra six months of exclusive marketing or patent protection for studying certain drugs in children.

"We see the rule as a real victory," says Janis Stire, executive director of the foundation. "For too long, children have been seen as an afterthought, with so many drugs not available to them. A child is not just half an adult to be given half the adult dose."

Protecting Older Patients

To help ensure the safe and effective use of prescription drugs in older people (specifically, aged 65 and older), a rule finalized by FDA in August 1997 requires drug companies to include a separate "Geriatric use" section in their drugs' labeling. Drug companies do not have to perform additional studies like the pediatric rule requires, but must include available information in a specific format and location.

"If the information is dispersed throughout the whole label, it doesn't make for a user-friendly information source," says Robert Michocki, a clinical pharmacist and professor at the University of Maryland's school of pharmacy. "People are busy. Physicians don't sit down and read the whole drug label. They try to read the important sections that answer questions like 'what's the dose?' or 'what are the side effects?'"

While drugs for everything from heart problems and high blood pressure to pneumonia and the flu can be lifesavers for older people, the dangers of medicine can be magnified in this population, too.

One reason for the increased risk is people's changing physiology as they get older, says Charles Ganley, M.D., FDA's medical team leader for cardiorenal drug products. For example, he says, certain drugs that are eliminated from the body by the kidneys could cause problems in the elderly because kidney function can decline with age.

Also, the elderly take more medicines than any other age group — around 30 percent of the prescription drugs sold in the United States, according to FDA, although they make up only about 12 percent of the country's population. The use of multiple drugs can increase the risk of dangerous drug interactions.

Michocki says, "start low and go slow" is an adage that applies to giving older people medicines. "For the most part, with older people you're using medications to try and manage their chronic diseases like diabetes or arthritis. There's no reason to go in there and try to fix something overnight."

The rule will prove beneficial, Michocki thinks, because "after reading the special section on geriatrics, a physician who is not familiar with the drug may start out giving half the dose he was going to give in the first place."

New labels are appearing gradually, first on those drugs that FDA has determined are most likely to create problems for geriatric patients. These include psychotropic drugs such as antidepressants and antipsychotics, as well as some heart medications and nonsteroidal anti-inflammatory drugs (NSAIDs).

About the Author

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