Patients Should Beware When New Drug for Overactive Bladder Soon Becomes Available Over-the-Counter

Advisory Committee Rejected Increased Availability but Was Ignored by FDA; Story Told in New Issue of Public Citizen’s Worst Pills, Best Pills NewsWASHINGTON, D.C. – When a new over-the-counter (OTC) version of a drug for overactive bladder becomes available without a prescription in the fall, people should avoid it if they haven’t first talked with their doctor, Public Citizen advises in the latest edition of Worst Pills, Best Pills News (WorstPills.org), Public Citizen’s drug safety newsletter and website.The manufacturer of oxybutynin (Oxytrol for Women), a drug for overactive bladder (OAB) symptoms that has been found to have serious and potentially fatal side effects, especially for the elderly, has announced that the drug will be available OTC starting in the fall, despite its risks. The OTC drug comes in the form of a patch applied to the skin.The U.S. Food and Drug Administration (FDA) gave drug manufacturer Merck the green light to advertise and sell the drug for women over 18, overriding the recommendation of an advisory committee that said the drug should not be available OTC because of its potential harm to the elderly and to those taking it without a doctor’s oversight.While the drug can be effective, the side effects can be serious: constipation, nausea and vomiting, difficulty swallowing, decreased sweating leading to heat-related injuries, difficulty urinating, increased heart rate, dry mouth, daytime sleepiness, blurred...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs