May 20, 2007

ADHD Drugs: Liver Injury, Heart Attack and Stroke

by Kevin Flatt

On March 21, 2000, 14-year-old Matthew Smith dropped dead of a heart attack while skateboarding. The ninth-grader had been on Ritalin since the first grade. Lawrence Smith, father of the youngster, has testified that he and his wife were forced by Michigan Social Services to put their child on Ritalin or else be charged for neglecting their son's educational and emotional needs. (WorldNetDaily.com January 3, 2003).

Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.

"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member. Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart. (The New York Times 9 February 2006).

The person who drove the decision was Dr Steven Nissen who's in the Department of Cardiovascular Medicine at the prestigious Cleveland Clinic in Ohio. He's written about it in the New England Journal of Medicine.

On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) voted by a narrow margin - eight to seven - to recommend a "black-box" warning describing the cardiovascular risks of stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD).

These agents substantially increase the heart rate and blood pressure. In a placebo-controlled trial, mixed amphetamine salts (Adderall) administered to adults increased systolic blood pressure by about 5 mm Hg; similar effects were found with methylphenidate formulations. Blood-pressure changes of this magnitude, particularly during long-term therapy, are known to increase morbidity and mortality. (Steven E. Nissen. ADHD Drugs and Cardiovascular Risk. New England Journal of Medicine 2006; 354: 1445-1448).

And what I said to the panel is look, you have two drugs that are extremely closely related congeners and yet we are treating four million Americans with these agents, two and half million children, one and a half million adults and 10% of adults taking these powerful stimulants are over the age of 50. My concerns stem from the understanding that if you raise heart rate and blood pressure, particularly in adults, you will increase the risk of myocardial infarction, stroke and sudden death. (Dr, Steven Nissen, ABC Health Report 27/03/2006).

The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children.

The labelling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labelling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events. (Medical News Today 18/12/2004).

A Food and Drug Administration advisory committee recommended Wednesday that the agency add information about a possible risk of hallucinations in children to the labels of attention deficit/hyperactivity disorder drugs.

The panel said the "MedGuide" also should note that ADHD drugs may increase the risk of aggressive behavior, although that can be a component of the disorder itself. And the guide should note that the drugs might increase the risk of heart attack, stroke or sudden death in patients who have undiagnosed heart problems. (USA Today March 23, 2006).

Copyright 2007 Kevin Flatt. Disclaimer: The information contained in this article is presented for information purposes only and is in no way intended to replace professional medical care or attention by a qualified practitioner. It cannot and should not be used as a basis for diagnosis or choice of treatment.

 
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