October 3, 2005 -- FDA Warns About ADHD Drug Strattera and Meningococcal Vaccine

In public health advisories issued September 29 and 30, the federal Food and Drug Administration (FDA) has alerted physicians that there have been reports of suicidal thinking in children and adolescents taking Strattera, a drug approved to treat attention deficit hyperactivity disorder. The FDA urged that persons taking the drug be closely monitored for agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dosage is increased or decreased. Strattera, manufactured by Eli Lilly, has been on the market since 2002 and has been used in more than two million patients.

In a second advisory, the FDA and the Centers for Disease Control and Prevention (CDC) alerted consumers and health care providers that there have been five reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known whether the GBS cases were caused by the vaccine or were coincidental, but the information is being made public because of the serious nature of Guillain Barre, a neurological disorder that typically causes increased weakening in the legs and arms and can require hospitalization. There are currently no changes in recommendations for the vaccine, which prevents a major cause of bacterial meningitis, a disease of primarily young adults that is potentially fatal.

Press releases announcing the two advisories are available at www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html.