First Medication Requiring a Medication Guide Pulled from Market by FDA

The Food and Drug Administration has pulled from the market the prescription medicine Lotronex, approved in early 2000 for treatment of irritable bowel syndrome in women. In August, it became the first prescription medicine to require a detailed instruction sheet for patients, or Medication Guide.
http://www.fda.gov/bbs/topics/ANSWERS/ANS01058.html