The FDA announced on June 29, 2005 that they are adding a new warning concerning psychiatric side effects to the label of Concerta. Concerta is used to treat attention deficit hyperactivity disorder, or ADHD. The FDA approved Concerta manufactured by Johnson and Johnson on August 1, 2000.
Reported psychiatric side effects of Concerta include suicidal thoughts, aggression, psychotic behavior and hallucinations. Concerta’s label already includes warnings about psychiatric side effects; the warnings may downplay the seriousness of the side effects.
The current label suggests that Concerta may exacerbate an existing psychiatric condition. However, of the 36 reports of psychiatric side effects among Concerta users, only 6 reported a history of a psychiatric condition. Additionally, the FDA has received reports of cardiovascular problems in Concerta users including hypertension, arrhythmia’s, chest pain, and tachycardia.
In 2004, 7.8 million prescriptions for Concerta were written in the United States. In addition to Concerta and Ritalin, the FDA is also investigating the ADHD drugs Adderall and Strattera.
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 meeting include
Adderall, Concerta, and Strattera
On February 9, 2006, Federal science advisers voted narrowly on proposing the most serious type of warning labels for Concerta, Adderall, Ritalin and all other ADHD drugs. The Food and 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’s 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.
Sales of Concerta, Adderall, Ritalin and other ADHD drugs increased to $3.1 billion in 2004, from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.