Nearly 250 infants and toddlers may die every year from bad reactions to drugs and treatments that no longer have to be tested in the youngest patients.
A new study appearing in the November issue of Pediatrics found that only 17 drugs and other therapies accounted for 54 percent of all serious and deadly adverse reaction reports to the U.S. Food and Drug Administration (news – web sites) (FDA).
However, a federal court recently overturned a 1998 FDA requirement that companies test products in children if they are often given to them. The U.S. District Court in Washington ruled the FDA didn’t have the authority to impose the so-called “pediatric rule.”
That court decision worries many pediatricians.
Dr. Carol J. Blaisdell, a University of Maryland pediatrician and a study co-author, says: “We pediatricians are very concerned about that and will hope that the Congress supports FDA authority” to force drug makers to test their products in children. “We do need to be looking at kids specifically, and we can’t assume that drug is safe and effective” in a child simply because it works in adults. The absence of a pediatric rule “leaves doctors without a lot of ability to know if what we’re doing is safe.”
Blaisdell adds the reports in the study aren’t proof that medication was responsible for the deaths.
“What we don’t know from this analysis is all the clinical issues that went into those children’s care,” such as whether they were very ill, had multiple medical problems, or didn’t receive an appropriate dose of the drug. Even so, Blaisdell says, the study relied on voluntarily reported events and likely far underestimates the risks of medications to young children.
Blaisdell and her colleagues culled through more than 7,100 reports to the FDA of adverse reactions to drug and biologic therapies between November 1997 and December 2000. Analyzing the cases, they found an average of 243 deaths a year linked to the substances, and a far higher number of serious but nonfatal complications. About 40 percent of the deaths occurred in the first month of life and 84 percent happened before the baby’s first birthday.
Leading the group of the most commonly reported drugs was palivizumab, prescribed to prevent severe respiratory infections. It was implicated in nearly 28 percent of cases. “This is a drug used for prevention, not for treatment of an illness once it is started,” Blaisdell says.
Second on the list was cisapride, a heartburn drug sold as Propulsid that was pulled from the market in 2000 after being tied to heart rhythm anomalies.
Ibuprofen, the active ingredient in painkillers such as Motrin and Advil, accounted for 33 reports of reactions, or 1.3 percent of the total.
A quarter of side effects were linked to mothers who exposed the baby to the substance during late pregnancy, delivery or through breast-feeding.
Susan Cruzan, an FDA spokeswoman, says the agency was “disappointed” in the court’s decision to overturn the pediatric rule. “We still believe it’s vitally important that drugs be studied in children,” she says.
Some drug makers elect to study their products in children, and Cruzan says “about 40” now have warning labels with pediatric information. The FDA has also encouraged pharmaceutical firms to study their products in children by offering them a six-month patent extension for their trouble. The 2002 Best Pharmaceuticals for Children Act renewed that provision.
Thomas J. Moore, a health policy analyst at George Washington University in Washington, D.C., says it’s too soon to tell if this year’s law will improve drug safety in children. However, he says marrying studies to patents could result in only the most profitable drugs undergoing pediatric testing.
“The pediatric rule provided the ability for the FDA to identify those [substances] for which proper information about the drug in children was most needed,” he says.