FDA takes action against use of OTC benzocaine teething products
FDA also targets prescription local anesthetics
WASHINGTON — The U.S. Food and Drug Administration is warning consumers that OTC teething products containing benzocaine pose a serious risk to infants and children and is asking that companies stop selling these products for such use.
If companies do not comply, the FDA stated that it will initiate regulatory action to remove these products from the market. The agency also is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores and irritation of the mouth and gums. The products are sold as gels, sprays, ointments, solutions and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.
In a Drug Safety Communication issued on Wednesday, 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.
“Given the accumulating evidence regarding benzocaine’s association with methemoglobinemia, we are 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 under two years of age to the remaining oral health care drug products containing benzocaine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition.”
The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA’s letter regarding these new Safety Labeling Changes.
P&G honors Menstrual Hygiene Day global initiative with donation
CINCINNATI — In honor of the upcoming Menstrual Hygiene Day, Procter & Gamble’s feminine protection brand Always is donating an additional one million period products to confront period poverty across the United States.
Through an ongoing partnership with hunger-relief organization Feeding America, Always aims to provide greater access to period supplies for girls and women in need. In the past 10 years alone, the brand has donated more than 80 million pads to girls who need them most.
Menstrual Hygiene Day, which takes place on May 28, is a global initiative launched in 2014 by P&G’s partner Wash United, which aims to raise awareness around the challenges women and girls face during their menstrual cycles.
“Lack of access to period products is a problem not just in developing countries, but also here in the U.S.,” said Jennifer Davis, vice president, North America Feminine Care and Global Tampax, Procter & Gamble. “This donation is just part of our ongoing mission and commitment to help empower girls and women everywhere with access to the products they need to manage their periods so they can focus on reaching their full potential.”
FDA issues warning letters to marketers of sunscreen pills
WASHINGTON — The U.S. Food and Drug Administration announced on Tuesday that it has sent warning letters to companies illegally marketing pills and capsules labeled as dietary supplements that make unproven drug claims about protecting consumers from the dangers of sun exposure without meeting the FDA’s standards for safety and effectiveness.
The companies are GliSODin Skin Nutrients, which markets Advanced Skin Brightening Formula; Napa Valley Bioscience, which markets Sunsafe Rx; Pharmacy Direct, which markets Solaricare; and Sunergized, which markets Sunergetic.
The FDA instructed these companies to correct all violations associated with their products and were advised to review product web sites and product labeling to ensure that the claims they are making don’t violate federal law.
“Consumers should be watchful for unscrupulous companies making unproven claims. When the FDA sees companies taking advantage of people’s desire to protect themselves from the harmful effects of the sun — we’ll step in. There’s no pill or capsule that can replace your sunscreen,” the FDA stated.
The FDA is also encouraging new research and regulations to further promote the safety and effectiveness of traditional sun protection products like sunscreen lotions, creams, sticks and sprays that are applied topically.
“When sunscreens first came on the U.S. market, sunscreen active ingredients were not thought to penetrate the skin. We now have evidence that it’s possible for some sunscreen active ingredients to be absorbed through the skin. This combination of a large increase in the amount and frequency of sunscreen usage, together with advances in scientific understanding and safety evaluation methods, has given rise to new questions about what information is necessary and available to support general recognition of safety and effectiveness (GRASE) of active ingredients for use in OTC sunscreens,” the FDA stated.