Black Box Warnings for Ritalin and Other ADHD Drugs
It’s official: an FDA science advisory committee has voted to recommend the most serious type of ‘black box’ warning labels for Ritalin and other stimulants used in the treatment of attention deficit hyperactivity disorder.
Following the FDA’s request that the panel consider additional ways of studying drugs used to treat ADHD (see our earlier article “FDA Reports on Deaths from ADHD Drugs”), an article carried by APA’s PsycPort reports that the science advisory panel immediately turned to the question of ‘black box’ labelling:
The 8-7 vote, with one abstention, by the Food and Drug Administration committee was to recommend adding “black box” safety warnings to ADHD drugs. Doctors prescribe the increasingly popular drugs to about 2 million children and 1 million adults a month.
The FDA isn’t required to follow the recommendations of its advisory committees but typically does.
The federal agency originally had asked the scientific panel to consider ways of studying the drugs, which include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.
The agency’s own data suggested a link between the drugs and an increased risk of sudden death and serious cardiovascular problems, including heart attacks.
The panel quickly turned to a debate on whether it should consider new warnings for the drugs rather than simply discuss the need for more studies.
Panel member Dr. Curt Furberg said it would be “inappropriate, unethical behavior” for the FDA not to disclose to doctors and patients that there was uncertainty about the safety of ADHD drugs.
Dr. Steve Nissen told his colleagues they should push for the black box warning on the drugs’ packages.
The drugs already bear warnings related to the possible risk they could pose to patients with heart defects, the FDA’s Dr. Gerald DalPan said.
“We feel this warning is appropriate given our current knowledge of these drugs,” he said prior to the votes.
The balloting on warning labels followed an earlier 15-0 vote to recommend that the FDA require that the drugs include a medication guide for patients and parents.
A federal health official said Thursday that there was a strong possibility the drugs may be linked to the deaths of 25 people.
Also see our recent article on the methylphenidate transdermal patch for ADHD, to be marketed soon under the brand name Daytrana: “ADHD Patch to be Sold as Daytrana”.
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