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The Health Research Group’s Seven-Year Rule |
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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... |
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The Health Research Group’s Seven-Year Rule |
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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 A number of new drugs have been withdrawn within their first seven years after release.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. |
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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. |
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The Food and Drug Administration (FDA) issued a Public Health Advisory on Sept. 29, 2005 to warn of suicidal thinking in children and adolescents being treated with atomoxetine (STRATTERA) for attention deficit hyperactivity disorder (ADHD).
The FDA has requested that the Eli Lilly and Co. of Indianapolis, the manufacturer of atomoxetine, add a black box warning to the drug’s professional product labeling. A black box is the strongest type of warning that the agency can request from a drug’s manufacturer. Because patients and their parents rarely, if ever, see a drug’s professional labeling, the agency will also require a Medication Guide. These are written specifically for the public and contain important risk information to be distributed with each new and refill prescription for atomoxetine.
Atomoxetine was approved by the FDA in November 2002. In 2004, more that 5.5 million prescriptions were dispensed for the drug, accounting for more than $646 million in sales in the U.S.
The new warning was based on an analysis of 12 controlled clinical trials involving over 2,200 patients comparing atomoxetine to a placebo. Eleven of the trials were in children and adolescents with ADHD and one in patients with bedwetting (pediatric enuresis). The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving atomoxetine.
The average risk of suicidal thinking was about 4 in 1,000 in those patients treated with atomoxetine. There were no reports of suicidal thinking in the patients treated with placebo. There was one suicide attempt in patients treated with atomoxetine. Based on these results, the FDA determined that the following information is appropriate for inclusion in the atomoxetine black box warning:
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Atomoxetine increases the risk of suicidal thinking in children and adolescents with ADHD.
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Anyone considering the use of atomoxetine in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.
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Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior.
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Families and caregivers should be advised to closely observe the patient and to communicate changes concerning behavior with the drug’s prescriber.
Pediatric and adolescent patients being treated with atomoxetine should be closely watched for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months treatment with the drug, or at times of dose changes, either increases or decreases. This monitoring should include daily observation by families and caregivers and frequent contact with the prescribing healthcare professional.
Atomoxetine was reviewed in the February 2005 issue of Worst Pills, Best Pills News and was listed as Do Not Use for Seven Years, or until 2010. We have concerns about the possibility of liver toxicity with the use of this drug.
The editors of The Medical Letter on Drugs and Therapeutics, an independent source of drug information written for pharmacists and physicians, reviewed atomoxetine in their April 16, 2004 issue. They 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.
What You Can Do
If you observe the changes in behavior listed above in a child or adolescent taking atomoxetine, contact the prescribing healthcare professional immediately.
