Modified on 2009/10/14 21:52 by admin
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 labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered.

The labeling 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 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 bolded warning indicates that the medication should be discontinued in patients who developed jaundice (yellowing of the skin or whites of the eyes) or laboratory evidence of liver injury.

Strattera has been on the market since 2002 and has been used in more than 2 million patients. In clinical trials of 6000 patients, no signal for liver problems (hepatotoxicity) had emerged.

FDA has asked the manufacturer to add a bolded warning about severe liver injury to the labeling. Eli Lilly has agreed to alert health care professionals about the new information in a Dear Health Professional letter. The company will also update the patient package insert with information about the signs and symptoms of liver problems, which include:
  • Pruritus (Itchy skin)
  • Jaundice
  • Dark urine
  • Upper right-sided abdominal tenderness
  • Or unexplained "flu-like" symptoms

In September 2005, the FDA directed Eli Lilly and Company to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication.

See your doctor if you have experienced serious health problems after taking Strattera. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Attorneys associated with will evaluate your case free of charge. In addition, you will not pay any fees unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.

See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Jaundice
  3. Liver Failure: Overview
  4. Liver Problems
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