Strattera Warnings

DO NOT USE UNTIL 2010 Liver Toxicity With The New ADHD Drug Atomoxetine (STRATTERA)
February 2005
On December 17, 2004 the Food and Drug Administration (FDA) issued a new warning for atomoxetine (STRATTERA), a drug approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children. The drug?s professional product labeling, or package insert, is being updated to include a bolded warning about the potential for severe liver toxicity following reports in two patients, a teenager and an adult, who had been treated with atomoxetine for several months. Both patients recovered.

On December 17, 2004 the Food and Drug Administration (FDA) issued a new warning for atomoxetine (STRATTERA), a drug approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children. The drug's professional product labeling, or package insert, is being updated to include a bolded warning about the potential for severe liver toxicity following reports in two patients, a teenager and an adult, who had been treated with atomoxetine for several months. Both patients recovered.

Atomoxetine is produced by Eli Lilly and Company of Indianapolis. It was approved by the FDA in late 2002 and has rapidly risen to the ranks of a top seller. In 2003, 3.5 million prescriptions were dispensed for the drug in the U.S. Retail sales exceeded $390 million.

We invoked our Do Not Use for Seven Years Rule for atomoxetine in the newly-released fourth edition of our book, Worst Pills, Best Pills, now available in bookstores. Our advice is that neither you nor your children should use this drug until 2010.

The new warning advises of severe liver injury that may progress to liver failure, potentially resulting in death or the need for a liver transplant in some patients. The labeling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events. The FDA estimates that as few as 1 in 100 to 1 in 10 serious adverse drug reactions are reported to the agency.

If you or a family member develop any of the symptoms of potential liver toxicity, atomoxetine should be stopped and the prescribing physician notified immediately. These symptoms are:

• Pruritus (itchy skin)
  
• Jaundice (yellowing of the skin or whites of the eyes)
  
• Dark urine
  
• Upper right-sided abdominal tenderness (location of the liver)
  
• Unexplained flu-like symptoms
  
• The editors of The Medical Letter on Drugs and Therapeutics, an independent source of drug information written for pharmacists and physicians we frequently cite, reviewed atomoxetine in their April 16, 2004 issue and concluded:
  

What You Can Do

You should not take atomoxetine until 2010. You should stop taking atomoxetine and contact the prescribing physician if you develop the symptoms of possible liver toxicity listed above.