FDA WARNS BENZOCAINE TEETHING PRODUCTS COULD CAUSE SERIOUS SAFETY RISK FOR INFANTS AND CHILDREN

The U.S. Food and Drug Administration is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency yesterday announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

Because of the lack of efficacy for teething and the serious safety concerns that have seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products.

Uses of Benzocaine:

Benzocaine is marketed to help relieve pain from a variety of conditions such as

ü Teething,

ü Sore throat,

ü Canker sores and

ü Irritation of the mouth and gums.

The products are sold as

ü Gels,

ü Sprays,

ü Ointments,

ü Solutions and

ü Lozenges

OTC brand names

ü Anbesol,

ü Baby Orajel,

ü Cepacol,

ü Chloraseptic,

ü Hurricaine,

ü Orabase,

ü Orajel and

ü Topex,

ü As well as store brands and generics.

Major ADR:

In a Drug Safety Communication issued yesterday, the agency builds on its previous warnings about risks associated with benzocaine products for Methemoglobinemia. This dangerous condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. The agency made specific recommendations to manufacturers in order to protect patients and make sure the most up-to-date drug safety information will appear on drug labels.

FDA actions:

FDA is taking necessary action to work with industry to discontinue the distribution and sale of over-the-counter benzocaine oral health products intended for teething pain, and add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children less than two years of age to the remaining oral health care drug products containing benzocaine. As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.

Advice to patients:

When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient and, if using these products, look for signs and symptoms of methemoglobinemia.

Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine. These include

ü Pale, gray- or blue-colored skin,

ü Lips and nail beds;

ü Shortness of breath;

ü Fatigue;

ü Headache;

ü Light-headedness; and

ü Rapid heart rate.

If any of these symptoms occur after using benzocaine, the person should receive medical attention immediately. All drug products, including local anesthetics, should be stored out of reach of children.

The FDA urges consumers and health care professionals to report adverse reactions involving benzocaine or other medicines to the FDA’s MedWatch program or respective ADR monitoring units. The FDA will continue to monitor the safety of benzocaine products and will take additional actions as appropriate.