public citizen wants black box warning for lubiprostone
TRANSCRIPT
Reactions 1252 - 16 May 2009
Public Citizen wants black boxwarning for lubiprostone
The consumer advocacy group Public Citizen has fileda petition with the US FDA calling for a black boxwarning about the risk of abortion or preterm labour tobe added to lubiprostone [Amitiza] label.
The group says that lubiprostone, which is prescribedfor chronic constipation in adults and irritable bowelsyndrome in women, is in the same class asmisoprostol, a drug widely used off label in medicalabortions. Unlike lubiprostone label, the label formisoprostol carries a warning about the risk of abortionor preterm labour. Public Citizen contends that "studiessubmitted with lubiprostone’s original drug applicationshowed that the drug caused a significant number ofdose-related abortions in guinea pigs, the appropriateabortion model for humans". The group wants FDA torecommend a black box warning for lubiprostone, thestrongest warning the FDA can issue. Also, the drugcompanies should provide patients with an FDA-approved medication guide, and the doctors with awarning letter, advising them of risk of abortion withlubiprostone, says Public Citizen. According to actingpresident of Public Citizen, Sidney Wolfe, "the current[lubiprostone] label is grossly inadequate as it lacksuseful information pertaining to the risks of drug-induced abortion in pregnant women". Also,lubiprostone should be moved from the ‘C’ to ‘X’pregnancy category of drugs, the same category asmisoprostol, which defines drugs that should not beused during pregnancy, Wolfe said.Public Citizen. Popular Drug for Constipation Poses Serious Risks to PregnantWomen; FDA Must Increase Warnings, Public Citizen Says. Media Release : 6May 2009. Available from: URL: http://www.citizen.org 809100573
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Reactions 16 May 2009 No. 12520114-9954/10/1252-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved