Proposal to give allergy info on OTC labels - over-the-counter topical first-aid antibiotics - Brief Article

FDA Consumer, July-August, 1996

In a recent proposal, FDA encouraged manufacturers of over-the-counter topical first-aid antibiotics to voluntarily re-label products containing any of six ingredients with a new warning about possible allergic reactions.

After a task group of the Nonrescription Drug Manufacturers Association reported more than 900 cases of allergic reaction to certain antibiotics, the firms had voluntarily put a warning on OTC products containing bacitracin zinc, neomycin sulfate, or polymyxin B sulfate antibiotics.

According to the group's report on cases of allergic reaction over the last few years, 261 were related to OTC products, while 631 were related to prescription products. Another 31 were unclassified due to lack of information.

Upon reviewing the report, FDA proposed, in the Feb. 14, 1996, Federal Register that products containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, and polymyxin B sulfate be labeled with this revised warning to include allergic reactions:

"Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if you are allergic to any of the ingredients. Do not use longer than 1 week unless directed by a doctor."

Among cases reported for OTC products, most listed the outcome as unknown. When outcomes were reported, however, the majority were minor skin reactions, and no deaths were reported. Most reports involved OTC products containing more than one antibiotic.

The increase in reports may be attributed to consumers' increased use of the products. FDA believes the additional information would be helpful to consumers.

(For more about OTC topical first-aid products, see "OTC Options: Help for Cuts, Scrapes and Burns" in the May 1996 FDA Consumer)

Consumer Reprints

New FDA Consumer reprints are available. Two are in Spanish, on teenage dieting and childhood vaccines, and five are in English, on various topics.

The reprints and their publication numbers are:

* Las Dietas en la Adolescencia (FDA) 96-1238S

* La Importancia de las Vacunas en la Ninez (FDA) 96-9016S

* On the Teen Scene: Yeast Infections FDA) 96-1236

* More People Trying Vegetarian Diets FDA) 96-2296

* Healthful Snacks for the Chip & Dip Crowd (FDA) 96-2300 Growing Older, Eating Better (FDA) 96-2301

* FDA's Tips for Taking Medicines: How to Get the Most Benefits with the Fewest Risks (based on "FDA's Rx for Better Medication Information") (FDA) 96-3221.

To order single copies, write to FDA, HFE-88, Rockville, MD 20857. To order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 443-9057. Include the publication number.