The Food and Drug Administration (FDA) is reviewing the safety of Lotronex after reports that five women died after using the medication. Lotronex is used for Irritable Bowel Syndrome (IBS) in women whose main symptoms is diarrhea. It is not to be taken by women who are troubled with constipation, have other digestive disorders, or a history of other digestive disorders.

     There have been 49 complaints of women developing ischemic colitis and 21 developing severe constipation after using the drug. Three of the women with ischemic colitis and two with severe constipation have died. It is still not clear what role Lotronex played in these deaths.

     Earlier this year the FDA required that a pamphlet outlining the risks of Lotronex be dispensed with every prescription. The pamphlet describes 33 side effects that have been reported.

     The consumer group Public Citizen is calling for Lotronex to be banned. A representative from Glaxo Wellcome Inc., the company that manufactors the drug, says the deaths may not be a result of Lotronex. They maintain that two of the women who died were not taking Lotronex at the time of death, and a third woman who died had a history of ischemic intestinal disease.

     The FDA has not concluded its investigation of Lotronex, and is currently negotiating with Glaxo Wellcome Inc. over a proposed consumer advertising campaign.

Full Story