Cautions Issued on Use Of Psychiatric Drugs
Thursday, February 9, 2006
Rare but serious side effects have been linked to two groups of widely used psychiatric drugs, according to new reports yesterday.
Newborns whose mothers took antidepressants such as Prozac, Paxil and Zoloft in the last trimester of pregnancy had six times the risk of suffering oxygen deprivation after birth compared with newborns whose mothers had not taken the drugs, according to a study published yesterday in the New England Journal of Medicine.
And a briefing document prepared by Food and Drug Administration officials reported that adults taking medications such as Adderall and Ritalin to treat attention-deficit hyperactivity disorder might be at higher risk of sudden death and other serious side effects, especially if they have high blood pressure. The FDA's findings were issued ahead of a meeting today aimed at figuring out how to study the risks.
The new reports follow two years of cautionary findings about several psychiatric drugs. Although the medications have been shown to help many patients, there are concerns that some subgroups of patients are at risk of serious side effects. Parents, patients and clinicians have struggled to balance serious but low-probability risks against known benefits, and researchers are trying to identify which patients might experience the problems.
The government analysis of the safety of ADHD medications said both children and adults taking the drug might be at increased risk, a worrisome finding because hypertension is so common in U.S. adults.
"Since hypertension is the most common primary diagnosis in America, it is reasonable to deduce that the adult population at increased risk of suffering a cardiovascular event associated with stimulant-based ADHD treatment may be high," wrote FDA safety investigators. The document noted that some sections had been redacted.
The warning flags on ADHD drugs were picked up through a program that tracks side effects in the general population, a database that makes it very difficult to distinguish problems associated with the drugs from those that would have occurred anyway.
The agency's safety officials noted that reports of adverse effects have grown in recent years as use of the medications had increased. Records dating to 1969 show that nearly three-quarters of all serious reported problems with amphetamines and half of all serious side effects with drugs such as Ritalin occurred between 1999 and 2003.
In that five-year period, there were 28 domestic deaths among patients taking Adderall and 16 domestic deaths among patients taking the drug methylphenidate, most commonly sold as Ritalin. The statistics excluded deaths among patients who were taking ADHD drugs in conjunction with other medications.
Laurie Ostroff-Landau, spokeswoman for Novartis Pharmaceuticals Corp., said the company's own review of Ritalin found that "there does not appear to be any increase in cardiovascular events associated with methylphenidate use in comparison to the expected rates in the general population." Shire PLC, which markets Adderall, did not respond to requests for comment yesterday.
FDA spokeswoman Susan Cruzan said the purpose of today's meeting is to design studies to better inform the agency about the possible risks of the drugs.
Lawrence H. Diller, a California pediatrician who wrote "Running on Ritalin," said the FDA was reacting "defensively" to the decision of Canadian authorities to halt sales of an extended-release amphetamine drug before it was put back on the market. The physician, who prescribes ADHD drugs but is worried they are overused, said that he thinks the drugs are largely safe for children but that adults might be at greater risk.
The separate report published in the New England Journal of Medicine examined whether mothers of babies with a condition known as persistent pulmonary hypertension had taken antidepressants during pregnancy. The condition is marked by newborns having trouble transitioning to breathing on their own; as many as one in five of such babies fails to survive.
The study found that women who used antidepressants in the latter half of their pregnancies, especially in the final trimester, had about a 1 percent risk of having a baby with the condition, a rate six times that of women who did not take those drugs.