Kline & Specter, PC, handled Adderall cases after warnings were sounded over possible heart problems linked to Attention Deficit Hyperactivity Disorder (ADHD) drugs taken by millions of children across the United States.
The American Heart Association in April 2008 called on all children to be tested for heart problems before being prescribed ADHD drugs such as Adderall. (See story)
This followed reports that 19 children had died suddenly and another 26 suffered strokes, cardiac arrests and other cardiac events while on the medication. The Canadian government removed Adderall XR from the market after receiving similar reports.
The U.S. Food and Drug Administration (FDA) ordered “black box” warnings on ADHD medications and in 2007 required that they carry guides warning of potential cardiovascular risks.
The FDA said it had received reports of serious adverse events in patients who took standard doses of ADHD drugs, including cases of sudden death. New guides were ordered for Adderall and other ADHD drugs.
Adderall, manufactured by England-based Shire Pharmaceuticals Group PLC, was banned by Health Canada officials in 2005 after reports linked Adderall XR to 20 fatalities, 14 of them children, and a dozen strokes. The officials noted that none of the adverse reactions were caused by overdose or misuse of the medication.
The U.S. FDA’s safety advisory committee in 2006 recommended that ADHD drugs carry a “black box” warning – the agency’s most serious warning – about the risk of heart attack and sudden death. The panel said many doctors and patients were unaware of the risks associated with the drugs.
In February 2007, the FDA further ordered the additional patient guide because of reports the agency received about serious cardiovascular events. It note that ADHD drugs also were associated with certain psychiatric symptoms, including auditory hallucination, paranoia and manic episodes even in patients who had no prior psychiatric problems.
U.S. sales of Adderall were roughly $600 million on an annual basis, with about 700,000 people taking Adderall XR and 300,000 using the immediate-release form, known simply as Adderall. The FDA approved Adderall XR (mixed salts of a single-entity amphetamine product) in October 2001.
Adderall was found in two studies to dramatically reduce hyperactivity and impulsiveness in children with ADHD – considered the most commonly diagnosed psychiatric disorder among children of school age. The medication was found to help these children focus, work and learn better. The extended-release form of the medication, Adderall XR, was considered a breakthrough since one capsule could be taken in the morning without a second dose needed during the school day.
FDA News -- The most comprehensive study of prescription ADHD medications and the risk of heart attack, stroke or other cardiovascular problems will be conducted by two federal agencies.
Philadelphia Inquirer - Feb. 10, 2006
Los Angeles Times - Feb. 10, 20060
Washington Post - Feb. 10, 2006