FDA Wants New Warnings on Laxative Labeling

FDA hopes warnings will reduce laxative overdoses, which, the agency claims, can be fatal.

Sweeping changes are coming to the labeling and packaging of laxatives that contain sodium phosphate. But if the Nonprescription Drug Manufacturers Association (NDMA) has its way, they might not happen so quickly, or be so sweeping.

FDA has decided to revise the packaging and labeling requirements for laxatives after receiving evidence that sodium phosphate can cause changes in the levels of sodium, potassium, phosphate, chloride, and calcium in certain users, which can be life threatening or fatal. The agency has also discovered that an overdose of sodium phosphate can produce an electrolyte imbalance in certain users, which can also be fatal.

In response, the agency published two rules in the May 21, 1998, Federal Register. The first (63 FR:27836–27844) is a final rule limiting the package size of oral over-the-counter (OTC): laxatives with sodium phosphate to no more than 90 ml and mandating a related warning statement on the label. The package size regulation took effect June 22, and the warning statement must be in place by September 18.

The purgative dose is 45 ml, and bottles were sold in 45-, 90-, and 240-ml sizes. Despite a warning label advising physicians to prescribe by volume and not by bottle and cautioning patients about the side effects of overdosing, "the multiple container sizes available in the marketplace have caused consumer confusion and appear to have been involved in several consumer deaths," the agency says. So the 240-ml size was taken off the market.

The labeling for oral products must now read, "Taking more than the recommended dose in 24 hours can be harmful." For rectal products, the new warning reads, "Using more than one enema in 24 hours can be harmful." Both kinds must also carry this phrase: "Do not take (or use) more unless directed by a doctor. See warnings."

But NDMA does not want the new labeling to go into effect in September. On July 15, the association met with FDA to voice its concern and notify the agency that it intends to petition for a stay in the effective date. "The concern is that there is not enough data to support that warning," says Meg Gratton, public affairs associate at NDMA.

Other labeling changes could come as a result of another rule proposed the same day (63 FR:27886–27893). The labeling on packages used by doctors would be expanded. Among the additions are warnings telling doctors not to prescribe such laxatives to those with congestive heart failure; to be cautious in prescribing to those with heart problems, preexisting electrolyte disturbances, and the elderly; to monitor electrolytes and to give sufficient fluids to prevent dehydration; and to advise patients to follow the recommended dose.

Further warnings for rectal sodium phosphate products would also be added. Doctors would be advised to administer the products themselves to children under age two and to patients with congenital megacolon or imperforate anus, to stop using the product if there is resistance to the enema tip, and to use with extreme caution in patients with a colostomy, atonic colon, or any rectal abnormality.

There would also be revisions to the labeling of OTC packages. Consumers would now be advised not to use the products for more than three days, instead of seven, without asking a doctor; not to give them to children under six, instead of under five, without asking a doctor; and to print the caution against using with children under two in both the warning and directions sections.

Because of new findings about time-to-effect in rectal products, this statement would be added to the directions: "If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum in 30 minutes because dehydration could occur."

The directions section would see other changes, including the addition of the statement, "Stop using if tip is hard to insert," and a reorganizing of the recommended dosages per age bracket in children.

Implementation would come 12 months after publication of a final rule. The comment period was scheduled to end August 19.

For more information, contact Cheryl A. Turner, Center for Drug Evaluation and Research (HFD-560), FDA, 5600 Fishers Ln., Rockville, MD 20857; 301/827-2222.

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