FDA Approves New ADHD Drug
Drug, Called Vyvanse, Designed to Lower Potential for Abuse
Feb. 27, 2007 -- The FDA has approved a new prescription drug, called Vyvanse, to treat attention deficit hyperactivity disorder (ADHD).
Vyvanse, a stimulant, will bear the same warnings as all other ADHD drugs. Those warnings include reports of heart-related problems -- including sudden death -- and new or worsening psychiatric problems.
Last week, the FDA reminded patients and doctors of those warnings and encouraged patients or their families to tell doctors about any family history or new symptoms of heart problems (such as chest pain, shortness of breath, or fainting) or mental problems (such as undue suspicion or seeing, hearing, or believing things that are not real).
Vyvanse was developed by New River Pharmaceuticals, which was recently bought by the drug company Shire.
Shire and New River announced the drug's approval on Feb. 23. In that news release, the drug companies said Vyvanse was developed to minimize the potential for abuse in such drugs.
However, Vyvanse's medication guide warns that the drug is a federally controlled substance "because it can be abused or lead to dependence."
Shire and New River say the FDA approved Vyvanse based on studies showing it eased ADHD symptoms in kids aged 6-12 more than a sham pill (placebo).
Those studies tested three doses of Vyvanse -- 30 milligrams (mg), 50 mg, and 70 mg. All three doses were effective for a full day, including the end of the day, according to Shire and New River.