Sudden deaths, heart attacks and strokes in people taking attention deficit disorder drugs have led U.S. regulators to seek advice on how to study the medications’ potential risk.
The Food and Drug Administration asked its standing committee of risk-management advisers to review reports of heart-related complications in children and adults using the medicines, the agency’s Web site said. The biggest makers of the drugs are Johnson & Johnson and Shire Plc, with combined quarterly sales of their products topping $300 million.
U.S. and Canadian regulators have been looking in the past few years at the potential heart risk of attention-deficit drugs, which are stimulants used to improve concentration. Health Canada in August allowed Shire to resumes sales in that nation of its Adderall attention-deficit drug, which earlier had been suspended on heart concerns.
“I will suspect Adderall will be part of the discussion” at the FDA’s Feb. 9 meeting, said Matt Cabrey, a spokesman for Basingstoke, England-based Shire.
The FDA’s posting did not list which drugs the meeting will cover. About 2 million American children have the disorder, which causes restlessness and difficulty concentrating, according to the U.S. National Institutes of Health’s Web site.
`Work With FDA’
Johnson & Johnson will work with the FDA as it considers these risks, said Kathy Fallon, a company spokeswoman. Concerta is a once-daily form of Ritalin, a generic medicine that a parent company of Novartis AG pioneered in the 1950s. Adderall contains amphetamine. Both medicines are known to cause heart problems, according to the NIH’s Web site.
Irregular heart beat is a “rare” complication of Eli Lilly & Co.’s Strattera attention-deficit drug, which is not a stimulant, the NIH’s Web site said. Officials at Indianapolis- based Lilly cannot tell from the FDA’s posting whether its medicine will be included at the meeting, Lilly spokeswoman Jennifer Bunselmeyer said.
Lilly anticipates that the FDA this year will ask a panel of advisers to consider the psychiatric risks of the drugs, Bunselmeyer said. Lilly in September said there had been “uncommon” reports of people having suicidal thoughts while taking Strattera.
The meeting on attention-deficit drugs and heart risk will be in Gaithersburg, Maryland. The few long-term studies done on ADD drugs have provided little information on heart risks, the agency said.
The same committee will discuss the FDA’s actions on Feb. 10 on painkillers and risk-management programs for Roche Holding AG’s Accutane acne drug and its generic versions, according to the agency’s posting.
The disorder’s official name is Attention Deficit Hyperactivity Disorder, often shortened to ADHD or simply ADD. The symptoms fall into categories of impulsivity, inattention and hyperactivity, although not all patients suffer from the hyperactivity component.