FDA Proposes Tougher Warning Labels on Antacids and Laxatives

The Food and Drug Administration plans to require stronger warning labels on non-prescription antacids, laxatives, antidiarrheal drugs, sleep aids and anti-nausea products, the agency announced Thursday.

Antacids containing calcium or magnesium would have to carry warnings that they could react with other drugs and advising people to get professional advice before mixing the medications, the FDA said in a statement.

The new labels would have to appear in a year.

On laxatives and antidiarrheal medications, the labels will say that the products contain water-soluble gums and warn that people taking them need to have adequate fluid in their system. Otherwise, the gum could get stuck on the way down, swell up in the throat or esophagus, and cause choking.

The FDA said 199 such cases were reported between 1970 and 1992 in products using those gums, and that included 18 deaths. The agency banned almost all weight-control products using water-soluble gums in 1992.

The warning label on laxatives and antidiarrheal medications would take effect in six months.

On sleep aids and anti-nausea products, the FDA has proposed a new label that would warn people with breathing problems, such as emphysema or chronic bronchitis, not to take those preparations unless told to do so by a doctor. The warning also would extend to people with glaucoma or trouble urinating because of an enlarged prostate gland.

The agency said the warning is needed because the active ingredients in these products are antihistamines. The proposed warning on the medications was published Thursday.