The FDA’s Pediatric Advisory Committee is examining the safety of Ritalin (Generic: Methylphenidate which contains the active ingredient methylphenidate. Reported psychiatric side effects of the attention deficit hyperactivity disorder drug include suicidal thoughts, aggression, psychotic behavior and hallucinations. The FDA plans to add a new warning to the label of Ritalin emphasizing the seriousness of these psychiatric side effects. Ritalin is also associated with serious cardiovascular side effects including cardiac arrhythmia, tachycardia, chest pain and hypertension.
Ritalin is associated with other serious side effects. In one small study of 12 children, scientists from the University of Texas and the M.D. Anderson Cancer Center found a link between Ritalin and increased risk of cancer. The 12 children in the study taking Ritalin all experienced a significant increase in their level of chromosome abnormalities, occurrences which are associated with increased cancer risk and other adverse health effects.
Assuming it holds up, this study doesn’t mean these kids are going to get cancer, but it does mean they’re exposed to an additional risk factor,” said Marvin Legator, a professor of environmental toxicology at the University of Texas Medical Branch at Galveston and the study’s principal investigator and senior author. “Smoking doesn’t mean you’ll get cancer. It’s a risk factor.” The study is the first to look at the potential chromosome-damaging effects associated with methylphenidate, the generic name for Ritalin, the most widely prescribed drug used to treat attention deficit/hyperactivity disorder (ADHD).
Additional side effects of Ritalin include loss of appetite, abdominal pain, sleep problems and headaches. If the drugs are taken long term, children may be smaller as a result of the appetite suppression side effect. Between 1991 and 1999, U.S. sales of Ritalin and the related drugs Concerta and Metadata CD increased more than 500 percent. Of the 29 million prescriptions written for Ritalin and other ADHD drugs in 2004, 23 million were for children.
Ritalin is manufactured by Novartis Pharmaceuticals. In June 2005, the FDA announced it will be investigating all ADHD drugs including Ritalin, Concerta, Strattera and Adderall.
On February 9, 2006, Federal science advisers voted narrowly on proposing the most serious type of warning labels for Ritalin, Concerta, Adderall 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’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 Ritalin, Concerta, Adderall 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.
Legal Help For Victims Affected By Ritalin
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