- The Washington Times - Wednesday, February 21, 2007

The Food and Drug Administration yesterday ordered the manufacturers of Ritalin and all other drugs federally approved to treat attention-deficit (hyperactivity) disorder (ADHD) to warn patients of cardiovascular and psychiatric risks associated with using the medications when taken at the usual doses.

“Medications approved for the treatment of ADHD have real benefits for many patients, but they have serious risks as well,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.

“In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in product labeling and in developing patient medication guides to better inform doctors and patients about these concerns,” Dr. Galson added.

“We are not discouraging use of these medications,” Dr. Thomas Laughren, head of FDA’s Division of Psychiatric Products, told reporters yesterday. But he said doctors should know the patient’s medical history and perform a physical examination before prescribing ADHD drugs because some people should not take them.

ADHD is a condition marked by inattention, extreme restlessness and impulsivity. The FDA says it affects 3 percent to 7 percent of schoolchildren and about 4 percent of adults. That translates into an estimated 3.3 million Americans 19 or younger, and about 1.5 million age 20 and older, the agency said.

FDA advisory panels last year reviewed the safety of ADHD drugs, many of which are stimulants. Two of the most widely prescribed are Ritalin, produced by Novartis Pharmaceuticals Corp., and Adderall, by Shire U.S. Inc.

Dr. Laughren said that from 1992 to February 2005, sudden death from cardiovascular problems was reported in 27 patients 18 and younger who were taking ADHD drugs. “About half of them had underlying cardiovascular” ailments, he said.

Nineteen deaths of children taking ADHD drugs were reported to the FDA from 1999 through 2003, the agency said last spring.

The FDA said in May that strokes or heart attacks were reported in 54 adults taking the medications from 1999 to 2003. Some of these patients had risk factors, the agency said.

Dr. Laughren stressed that the federal drug-regulatory agency “does not have good information” indicating that ADHD drugs caused the cardiovascular events, but noted that two advisory panels recommended early last year that a risk be noted in warning language on the drugs and in medication guides distributed to patients and their caregivers. He said the panels thought the drugs might have contributed to the cardiovascular problems.

One panel initially advised a “black box warning,” the FDA’s most serious admonition, but that recommendation was not implemented for the drugs.

The two panels also recommended that warning labels and the patient medication guides indicate that use of ADHD drugs are associated with an increased risk (one in 1,000 patients) of psychiatric symptoms such as hallucinations, delusions and manic behavior in people who previously had not experienced them.

“There has always been language about these drugs worsening psychiatric problems for those with psychiatric problems,” but warnings were added last year for those without such a history, as well, Dr. Laughren said.

The labeling changes were implemented by early last fall, he said, but it took the FDA longer to order completion of the patient medication guides. The agency sent letters to all manufacturers of ADHD drugs yesterday, giving them 30 days to comply.

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