The FDA voted for this “black box” warning, notes the Associated Press in an article dated February 9, 2006, after being informed of the deaths of 25 individuals who were taking Ritalin.  Nineteen of the individuals were children. 

Though the vote was close (8-7), many FDA members felt quite strongly about issuing the strongly-worded black box warning.

  Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs.  

Currently, these drugs are prescribed to about 2 million children and 1 million adults each month, notes the AP article.  The drugs that would carry the warning fall into the family of methylphenidates and would include Ritalin, Concerta, Methylin and Metadate.  Another commonly used ADHD drug, Adderall, has carried the block box warning since 2004 because it is considered an amphetamine.

Ritalin has been on the market since 1955 and the company that produces the drug, Novartis, maintains that it is safe for the vast number of people who take it daily. They note that in the 50 years since Ritalin was introduced, there is no evidence of increase in cardiovascular programs associated with the use of the drug.  The drugs label, however, has always noted that the drug may be detrimental to users who already have a pre-existing heart condition.  

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, said his suggestion for the warnings was meant partly to slow what he believes is the "out of control growth" use of the drugs.  Astonishingly, notes the article, about 2.5 million children between age 4 and 17 take ADHD drugs and use among adults grew 90% between 2002 and 2005.