The FDA awarded Shire Pharmaceuticals approval for Adderall on November 8, 2002. Adderall is used by approximately 700,000 Americans and is one of the most popular drugs for people with Attention Deficit Hyperactivity Disorder (ADHD). Adderall contains amphetamine and dextroamphetamine, which are both stimulants. Shire Pharmaceuticals Group PLC sold $759 million of Adderall XR in the U.S. and roughly $10 million in Canada in 2004.
On February 9, 2005, Health Canada, the Canadian drug regulatory agency, suspended sales of Adderall in Canada. Adderall is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients.
In a news release, Health Canada said, “the incidence of serious adverse reactions leading to death was higher in” the extended release and earlier formulations of Adderall, when added together, than in other drugs in the same class. Of the 20 deaths reported in patients taking Adderall, 12 were from strokes, and two were in children, Health Canada said.
FDA is evaluating Adderall Adverse Effects
On January 3, 2006, the Food and Drug Administration asked its standing committee of risk-management advisers to review reports of heart-related complications in children and adults using attention deficit disorder drugs. U.S. and Canadian regulators have been looking in the past few years at the probable heart risk of attention-deficit drugs, which are stimulants used to improve concentration.
The three main ADHD drugs that will be reviewed at the February 9, 2006 FDA review meeting include Adderall, Concerta, and Strattera.
In August 2005, Health Canada allowed Shire Pharmaceuticals to begin selling Adderall again.
On February 9, 2006, Federal science advisers voted narrowly on proposing the most serious type of warning labels for Adderall, Concerta, Ritalin and all other ADHD drugs. The Food Drug Administration (FDA) Committee voted 8-7, recommending the adding of black box safety warnings to ADHD drugs. Doctors prescribe ADHD drugs to approximately 2 million children and 1 million adults a month.
The FDA data suggested a link between ADHD drugs and an increased risk of sudden death and serious cardiovascular problems, including heart attacks. Dr. Steve Nissen told his colleagues they should push for the black box warning on the ADHD drugs’ packages. A federal health official said Thursday that there was a strong possibility the drugs may be linked to the deaths of 25 people.
The deaths took place between 1999 and 2003, based upon a FDA report. Nineteen of them involved children. The report also detailed 54 cases of severe cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia, in adults and children being treated with ADHD drugs.
Adderall, Concerta, Ritalin and other ADHD drugs Sales Increase
Sales spike from $759 million to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm.