title: Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.
abstract: Several high-profile drug withdrawals for safety issues have brought into focus the FDA's process for approving drugs and monitoring adverse experiences with those agents after marketing has begun. Gastroenterologists and their patients have been affected adversely by removal from the marketplace of two licensed agents for irritable bowel syndrome (IBS): alosetron and tegaserod. The criteria used by the FDA for assessment of the risks and benefits of drugs used for functional bowel problems seem to be different than those used for the treatment of other conditions and have resulted in drastic limitation of access to these drugs rather than just warnings about risks as they are discovered. Decisions that affect the availability of drugs for patients with functional bowel disease should be discussed with clinicians who take care of those patients before going into effect. The absence of this sort of consultation leaves physicians with serious limitations on their abilities to take care of patients.
authors.affiliation: Digestive Health Associates of Texas, Baylor University Medical Center, Dallas, Texas 75246, USA.
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Schiller
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002243:Carbolines / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D007211:Indoles / Q000009:adverse effects*; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D011358:Product Surveillance, Postmarketing; D012306:Risk; D017366:Serotonin Receptor Agonists / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D002243:Carbolines; D005765:Gastrointestinal Agents; D007211:Indoles; D017366:Serotonin Receptor Agonists; C090840:alosetron; C105050:tegaserod