June 13, 2012

Warn Customers That Tooth Pain Gel Can Endanger
Children, Some Adults

Washington, D.C.Benzocaine products, sold on your pharmacy shelves as gels, liquids, sprays, and lozenges, are not as harmless as they may appear. They can be dangerous for certain users, especially children and adults with some chronic illnesses or who smoke, according to the FDA.

The FDA began warning about the potential dangers of benzocaine gel-related cases of methemoglobinemia in 2006 and, since then, has received 29 reports of the blood disorder. Most of the cases (19) occurred in children, and 15 of those were in children under 2. The FDA has expressed particular concern about the use of OTC benzocaine products for small children with teething pain.

The FDA recommends that benzocaine products not be used for children younger than 2 years, except under the advice and supervision of a health care professional.

Methemoglobinemia can cause pale, gray, or blue-colored skin, lips and nail beds; shortness of breath; fatigue; confusion; headache; light-headedness; or rapid heart rate.

“Symptoms can occur within minutes to hours after benzocaine use,” says FDA pharmacist Mary Ghods, RPh, “They can occur after using the drug for the first time, as well as after several uses.”

Pharmacists and other health professionals should advise parents to stop using the product and call 911 if their child has any of these symptoms after using benzocaine, Ghods says. If left untreated or if treatment is delayed, permanent injury or even death can result from the insufficient amount of oxygen in the blood.

For adults, FDA recommends that a health care professional be consulted before benzocaine use in patients who smoke or those with heart disease, asthma, bronchitis, or emphysema.

Use of benzocaine gels and liquids should be limited to no more than four times a day, the FDA says.

It also points out that labels on OTC products containing benzocaine are not currently required to carry warnings about the risk of methemoglobinemia.

So how should pharmacists advise parents on treating teething pain without benzocaine? FDA suggests they try a teething ring chilled in the refrigerator or massage the child’s gums with a finger. For stronger pain relief, they need to contact their pediatrician.

U.S. Pharmacist Social Connect