FDA spokeswoman Susan Bro says GlaxoSmithKline's Dexetrine drug and Novartis AG's Ritalin must now include warnings about risks of serious heart problems and sudden death. ADHD drugs act as stimulants and can raise blood pressure, possibly triggering heart trouble. Users of the drugs are also at risk of displaying behavioral problems -- which the drugs are often prescribed to treat -- such as aggression and mania.
Bro was unable to confirm whether Johnson & Johnson's Concerta drug and Eli Lilly's Strattera were also included in the warning mandate. However, Strattera already includes cautions about suicidal thoughts, and Shire Plc's Adderall warns users that abuse can cause heart problems.
Bro also could not confirm whether the warnings would be in a "black box" -- the FDA's strongest warning. However, on Monday, Glaxo's letter alerting doctors of the new warnings indicated that the caution was boxed.
The decision comes after two separate outside review panels split on whether or not to include warnings, and whether or not to enforce a black box on the warnings. Some doctors say they are concerned that the warnings could frighten patients away from using the drugs. The FDA estimates roughly 1 million adults and 2 million children fill ADHD drug prescriptions every month.
Critics of ADHD drugs say the medications are not only dangerous, but largely unnecessary and overprescribed. "Black box warnings," said Mike Adams, a consumer health advocate and critic of the practice of medicating children with psychotropic drugs, "are a clever tool used by the FDA to avoid banning dangerous drugs. By resorting to warnings that most consumers and doctors ignore, the agency can imply that responsibility for harm is shifted to the consumer. In reality, the FDA shoulders the full blame for allowing these dangerous drugs to remain on the market."