A report was issued today by the [FDA] stating that cases of sudden death and serious side effects including hypertension, heart attack and stroke have been linked in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both children and adults.
The [ FDA Advisory Committee ] further says that "Cardiovascular events associated with drugs for ADHD will be discussed with the FDA's Drug Safety & Risk Management Advisory Committee Feb.9-10." Meanwhile, the committee also says that little information is known on heart problems associated with ADHD due to "few controlled clinical studies."
Last June, the FDA said it was going to carefully review all ADHD treatments on the market in the wake of an investigation into the safety of ADHD products based on the stimulant drug methylphenidate, including Johnson & Johnson's once-daily Concerta product. But nothing was done and there were no label changes.
Heart problems associated with ADHD patients have mainly gone unnoticed. They have remained secondary concerns to ADHD patients because suicidal thinking and potentially harmful psychiatric events take precendence, particularly in the US.
Even after February 2005, when Canadian health authorities suspended the marketing of Shire's Adderall XR due to reports of sudden death, heart-related deaths and strokes in children and adult patients using the extended-release amphetamine, the FDA didn't remove the product. Adderall was later reinstated in Canada.
Pharmacy benefits company Medco reports that use of ADHD products has increased rapidly, up to 23 percent among young adults (aged 20-34), 33 percent in adults aged 39-49 and 36 percent in those aged 50-64.
The FDA's studies on Adderall XR from 1999 through 2003 found 12 sudden deaths in Adderall XR patients, with five occurring in patients with underlying cardiac abnormalities. After this FDA review, Adderall XR labeling added a statement to its boxed warning that "misuse of amphetamine may cause sudden death and serious cardiovascular adverse events."
On its website, the pharmaceutical company [Shire] states that Adderall "was generally well tolerated in clinicial studies."
LAWSUITS NEWS & LEGAL INFORMATION
ADHD Medications could prove Deadly
|. By Jane Mundy|
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