Dexedrine Possible Heart Risks. On August 21, 2006, GlaxoSmithKline announced it would add a strong warning about possible heart risk to its attention deficit hyperactivity drug (ADHD) Dexedrine. Dexedrine (Generic: Dextroamphetamine sulfate) gained FDA approval on July 9, 1997.
In March 2006, an FDA panel stated new information about heart risks should be added to the labels for attention deficit drugs. The outside experts stopped short of supporting a black box warning, the strongest warning possible saying they did not want to scare off patients or their parents. Additionally, in February 2006, a different FDA panel recommended black box warnings for all ADHD drugs.
psychiatric adverse events
Packaging for the drug will also contain additional information about possible psychiatric adverse events, like hallucinations and mania, linked to ADHD drugs, according to the letter dated Aug. 4, 2006.