FDA Issues Warning About Drug Used to Treat ADHD
WASHINGTON, DC — January 21, 2005 — The Food and Drug Administration (FDA) is warning doctors about Strattera®, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children (FDA Talk Paper, December 17, 2004). Two patients treated with Strattera® (atomoxetine HCl) developed severe liver injuries. A new alert in bold lettering on the Strattera® label includes this information. It also states that in a small percent of patients, liver injury may lead to liver failure and death or the need for a liver transplant. The number of actual cases of severe liver injury is unknown because adverse reactions to Strattera® may have been underreported, the FDA says.
The FDA recommends that patients see their doctors and stop taking Strattera® at the first sign of liver problems, which include:
- Pruritus (itchy skin)
- Jaundice (yellowing of the skin or the whites of the eyes)
- Dark urine
- Tenderness in the upper right side of the stomach or abdomen
- Unexplained “flu–like” symptoms
How Strattera® Works
Scientists do not know exactly how Strattera® works. One theory is that it blocks or slows reabsorption of norepinephrine, a chemical in the brain that may regulate attention, impulses, and activity (Am J Health Syst Pharm. 2004 Nov 15; 61(22): 2391–9). The result is that more norepinephrine stays in the spaces between neurons in the brain, which may help reduce symptoms of ADHD.
ADHD affects three to seven percent of children, or about 2 million school children in the United States (National Institute of Mental Health). It is marked by reduced attention span, lack of concentration, excess activity, and poor impulse control. About four percent of adults have the disorder, according to the nonprofit group, CHADD (Children and Adults with Hyperactivity Disorder). For more information about ADHD, see the discussion on the National Institute of Mental Health web site.
For further details about the side effects of Strattera®, see a letter to doctors by Eli Lilly, the manufacturer of the drug. If you have had medical problems due to an unsafe medication, please feel free to contact us at Brayton Purcell to learn more about your legal choices. We have been handling medically–related litigation for over 20 years, and work hard on behalf of our clients.