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FDA ACTIONS ON OTC WARNING LABELS

 WASHINGTON, Aug. 26 /PRNewswire/ -- FDA today announced that several categories of non-prescription drugs will carry new or expanded labeling statements warning consumers about possible interaction with other drugs and clarifying other information that consumers should know before using the medications.
 New warning statements will be required on antacids, laxatives and antidiarrheals. New warning statements are being proposed for sleep aids and antiemetics (drugs to treat nausea and vomiting).
 FDA Commissioner David A. Kessler, M.D., said consumers should read label directions and warnings on all over-the-counter medications to ensure they are using the products safely and effectively.
 "Although these drugs are available without prescription, many of them carry the potential for interaction with other over-the-counter or prescription drugs, overdose or adverse effects on people with certain existing medical conditions," Kessler said. "The new label requirements and proposals are designed to provide consumers with added information they need to use these products safely."
 ANTACIDS -- Labels on aluminum-containing antacids currently warn that the products should not be used when taking tetracycline, a prescription antibiotic, by mouth. Recent scientific evidence has shown that calcium- and magnesium-containing antacids also can interact with some prescription drugs.
 The new label statement on antacids warns consumers who are taking prescription drugs not to use the antacid product without medical guidance. It reads: "Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional." The new statement will be required to appear on antacid product labeling in one year.
 LAXATIVE AND ANTIDIARRHEAL PRODUCTS -- The new warning statement on laxatives and antidiarrheals containing water-soluble gums as active ingredients states: "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 statement will be required on labels of such products in six months.
 Water soluble gums are natural or synthetically derived gums that swell in size when mixed with water. They include agar, carrageenan, glucomannan, kelp, guar and xanthine gums and bulking agents such as psyllium, carboxymethylcellulose and polymannose acetate.
 Between 1970 and 1992 at least 199 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. Virtually all weight control products containing water-soluble gums were banned from the marketplace by FDA in March 1992.
 SLEEP AIDS AND ANTIEMETICS -- The proposed new warning for sleep aids and antiemetics states: "Do not take this product, unless directed by a doctor, if you have breathing problems such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland."
 Current labeling warns against use of sleep aids and antiemetics by asthma patients. The proposed warning statement would delete this reference, based on a recommendation of an FDA advisory committee. FDA agrees with the committee that evidence does not support continued use of the warning about possible adverse interactions with antihistamines when used to treat asthma.
 Also in the proposed statement, several terms are being changed. For example, the term "breathing problems" will replace a more lengthy description of symptoms.
 FDA is proposing these changes because the active ingredients in sleep aids and antiemetics are also classified as antihistamines.
 The new warning statements required for antacids, laxatives and antidiarrheals and the proposed warning statement for sleep aids and antiemetics were published today in the Federal Register. Written comments on the proposal may be sent within 60 days to: Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 8/26/93
 /NOTE TO EDITORS: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Mike Shaffer of the Food and Drug Administration, 301-443-3285 or, after hours, 301-831-9364/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

TW -- DC005 -- 6066 08/26/93 10:29 EDT
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Date:Aug 26, 1993
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