advertisement
© 2004 American Academy of Pediatrics
Strattera label updated to warn of potential severe liver injury
The Food and Drug Administration (FDA) is advising health care professionals about a new warning about the potential for severe liver injury in patients taking amoxetine HCl (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 reported cases of severe liver injury in a teenager and an adult who had been treated with Strattera for several months. Both patients have since 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. It 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 or laboratory evidence of liver injury. Currently, routine liver function tests are not being recommended for those taking this medication. Health care professionals are encouraged to report any unexpected adverse events associated with Strattera directly to Eli Lilly at (800) LillyRx (800-545-5979) or to the FDA MedWatch program at (800) 332-1088. The MedWatch form is available online: www.fda.gov/medwatch/safety/3500.pdf, by fax: (800) 332-0178, or mail: MedWatch, HFD-410, FDA, 5600 Fishers Lane, Rockville, MD 20857.
  CiteULike  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
