OTC LAXATIVES, ANTIDIARRHEALS CONTAINING WATER-SOLUBLE GUM

OTC LAXATIVES, ANTIDIARRHEALS CONTAINING WATER-SOLUBLE GUM as the active ingredient will be required to bear a warning statement that the product should be taken with adequate fluids. The warning statement, which was published in the Aug. 26 Federal Register along with three separate OTC monograph amendments (see following stories), will be incorporated into the final monograph labeling for OTC laxative, antidiarrheal and any other applicable products as the documents are finalized by FDA. The warning statement cautions consumers that "taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention." The FDA final rule also specifies that directions for use of all OTC products containing water-soluble gums should instruct consumers to take (or mix) the product with "at least eight ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See warning." The warning and direction statements should be featured in bold print and capital letters, FDA said, and incorporated on applicable OTC drug labels by Feb. 28, 1994. FDA estimated that it would cost the industry "less than $ 1 mil." to implement the label warnings. FDA defined water-soluble gums in the notice as "hydrophilic gums and hydrophilic mucilloids, including, but not limited to, agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth and xanthan gum." Although some of these ingredient names are "no longer official" and others cannot be sold OTC, FDA said that it included them in the final reg because "they do appear in the labeling of some products." Water-soluble gums are contained in OTC products including Ciba Consumer's Fiberall, Lederle's FiberCon, SmithKline Beecham's Citrucel, Procter & Gamble's Metamucil, Rhone-Poulenc Rorer's Perdiem and Menley & James' Serutan. The agency explained in the notice that the warnings for water-soluble gum-containing products were deemed necessary after FDA evaluated "reports of esophageal obstruction and asphyxiation involving OTC drug products containing water-soluble gums as active ingredients." FDA elaborated that between 1970 and 1992 "at least 191 cases of esophageal obstruction and eight cases of asphyxia associated with orally administered over-the-counter laxative and weight control products containing these ingredients" were reported. Eighteen deaths occurred among these cases, the agency noted, adding that the reports led FDA to remove almost all water-soluble gum-containing weight control products from the market in March 1992. Explaining the mechanism by which water-soluble gums pose hazards, FDA noted that "because of the hydrophilic nature of water-soluble gums, when water is added to the gum it swells and increases in bulk. If inadequate water is added, a viscous, semi- solid mass forms." The agency noted that the "rate and degree of swelling, as well as the viscosity and adhesiveness of the mass, vary from product to product depending on the amount of gum present." Therefore, when water-soluble gum-containing OTCs are ingested by people who have difficulty swallowing, or when they are taken with inadequate amounts of fluids, "there is a risk that the product will swell and form a viscous adhesive mass that can block the throat or esophagus," FDA said. FDA initially proposed to require a warning for all OTC drug products containing water-soluble gums as active ingredients in October 1990. At that time, the agency proposed the statement: Take or mix "this product with at least eight ounces (a full glass) of water or other fluid. Taking this product without adequate fluids may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have ever had difficulty in swallowing or have any throat problems. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention." FDA decided to remove the first sentence of the proposed warning statement and instead inserted the sentence in a separate directions-for-use statement that refers the consumer to the main warning statement. Comments received by the agency argued that the all-encompassing warning/directions statement was "overly broad in scope and would not serve properly to warn consumers." The agency also revised the third sentence of the proposed warning ("Do not take this product if you have ever had difficulty in swallowing or have any throat problems") to "Do not take this product if you have difficulty in swallowing" due to industry suggestions. Some comments, according to FDA, maintained that the proposed third sentence "could apply to almost all consumers because nearly everyone at some time has had a sore throat . . . that resulted in difficulty in swallowing." Among clarifications made to the proposed warning, FDA underscored that the warning statement applies to all OTC dosage forms that incorporate water-soluble gums as active ingredients, and does not apply to products that contain water-soluble gums as inactive ingredients. In response to industry comments, the agency specified that products subject to the warning requirement should also be in "dry or incompletely hydrated form, including those intended to be hydrated by the consumer." OTC drug products containing water-soluble gum that are marketed in a "completely hydrated form will not require the warning," FDA said. In response to the rash of incidents stemming from water soluble gum-based products, FDA has taken several regulatory actions to remove or seek reformulation of products that the agency views as hazardous. For example, the agency has grappled with Food Source One manufacturer National Dietary Research since 1988 about whether the product is a food or a drug and should be removed from the market ("The Tan Sheet" May 10, p. 12). In August 1990, FDA also told Rhone-Poulenc Rorer that it would have to reformulate or relabel its psyllium-containing laxative Perdiem due to an "unacceptably large number of cases of esophageal blockage" reported with the product. More recently, General Nutrition Corp. and Nature's Way signed an "assurance of voluntary compliance" agreement with state attorneys general in March, agreeing to recall weight loss products containing more than .5% guar gum ("The Tan Sheet" May 17, p. 7).