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Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis. |
The Health Research Group’s Seven-Year Rule You should wait at least seven years from the date of release to take any new drug unless... |
Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis. |
The Health Research Group’s Seven-Year Rule You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labeling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release. |
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:
There is no convincing evidence that atomoxetine (Strattera) is as effective or as well tolerated as stimulants such as methylphenidate (Concerta, and others) for treatment of ADHD. As The Medical Letter recommended when the drug was first marketed, until more data become available, atomoxetine is best reserved for patients who have not responded to or cannot tolerate stimulants, and for those who do not want to take, or have their children take, a controlled substance.
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.
