Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Thirty-eight drugs have new labeling approved by the Food and Drug Administration (FDA) outlining new BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS and/or ADVERSE REACTIONS, according to the FDA’s MedWatch July 2009 Drug Safety Labeling Changes posting.

A boxed warning is the sternest warning the FDA issues. Three drugs now have or updated updated information on their black box warning – Chantix (varenicline) 0.5 mg and 1 mg tablets, Wellbutrin (bupropion hydrochloride) tablets, sustained-release and extended release (XL) tablets, and Zyban (bupropion hydrochloride) sustained-release tablets. All three boxed warnings include risk for neuropsychiatric events including suicidality. All three drugs also have updated warnings and precautions. Chantix has updated its adverse reactions section as well.

New contradictions, warnings and adverse reactions have been added to the labeling of Ortho Evra (norelgestromin/ethinyl estradiol) birth control patch. The labeling emphasizes the risk of patients developing blood clots from elevated levels of estrogen. Those adverse events have resulted in serious injury or death in young women.

Other medications that had modifications to the BOXED WARNING, CONTRAINDICATIONS, ADVERSE EVENTS and WARNINGS sections in the FDA posting include Diabeta (glyburide), Lopid (gemfibrozil), Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), and Soliris (eculizumab).

This entry was posted on Friday, August 28th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.