Concerta, Ritalin and other drugs widely used to treat attention deficit hyperactivity disorder (ADHD) may lead to the possibility of hallucinations and suicidal tendencies in patients taking the drugs.
While such reports of serious psychiatric problems are rare and there is no proof they were caused by the drugs, the FDA has said a fuller discussion of the reports should be on drug labels. Current labeling discusses psychiatric problems that could be associated the drugs, but agency officials said they believe the labels do not clearly spell out the frequency and types of specific psychiatric problems.
The FDA made its decision to rewrite labels after reviewing 135 adverse event reports from Dec. 4, 2003, to Jan. 4, 2005, involving Johnson & Johnson's Concerta, a long-acting form of methylphenidate, the generic name for Ritalin, made by Novartis AG.
The Concerta review was mandated by law in drugs that are studied for use in children. Almost eight million prescriptions were written for Concerta during the same time period covered by the FDA review.
The FDA brought the review of Concerta to its pediatric advisory panel for advice on how best to communicate its concerns to the public. The agency chose not to focus on another category of ADHD drugs that includes Shire Pharmaceuticals PLC's Adderall, which was ordered off the market earlier this year in Canada after reports of 20 sudden deaths in patients, including 12 strokes.
The FDA has also been reviewing ADHD drugs for links to more serious problems like stroke. The drug labels warn of increased blood pressure and suggest the drugs can make any underlying psychiatric disorders worse, but patients may not be fully informed of the risks.
The most concerning serious side effects have been psychiatric events in young people. These have ranged from hallucinations, to suicidal thoughts, and even suicide attempts.
If you or a loved one has taken any ADHD drugs and suffered serious side effects, contact us today to find out if you might have a personal injury claim.