FDA Panel Recommends Black Box Warning on ADHD Drugs - Ritalin and Generics included

February 9th 2006

Ritalin

The Food and Drug Administration (FDA) advisory panel voted 8-7 to require “black box” warnings on Ritalin and other stimulant drugs used for treating attention deficit hyperactivity disorder (ADHD). The black-box warning is the strongest warning that can be placed on a product that has been approved by the FDA.

The FDA did this after hearing about the deaths of 25 people. Of these deaths, 19 were children. According to a CBS report, doctors prescribe these drugs to about 2 million children and 1 million adults a month. The drugs that will receive the new warning are Adderall (made by Shire Pharmaceuticals), Ritalin (made by Novartis Pharmaceuticals Corp.), Concerta (made by Johnson & Johnson), Methylin (made by Mallinckrodt Pharmaceuticals), and Metadate (made by UCB). Also the generic versions of Ritalin will need to carry the warning.

The Drug Safety and Risk Management advisory committee recommended that the drugs include a medication guide. This should include warnings to patients with certain pre-existing heart conditions, since recent reviews of FDA data suggested a link to serious cardiovascular problems including heart attack.

The FDA reviewed their data and found 25 reports of death among people that used these drugs. They also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia. Some of those cases involved patients with pre-existing heart conditions or hypertension.

The drugs are used to stimulate the central nervous system in an effort to treat people that have difficulty concentrating and controlling their behavior. This is the third time in two years the FDA has addressed the heart related side effects from these drugs. According to Bloomberg News, prescriptions jumped 90 percent from March of 2002.

Ritalin was first approved by the FDA in 1955. Novartis says the drug is safe and effective. The FDA usually follows the advice of their advisory panels.