FDA: Teething OTC drugs associated with risk of methemoglobinemia
SILVER SPRING, Md. — The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter. Benzocaine products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
The agency recommended that benzocaine products should not be used on children younger than 2 years of age, except under the advice and supervision of a healthcare professional. Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations on the product label.
Methemoglobinemia is a rare but serious condition in which the amount of oxygen carried through the bloodstream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience such signs and symptoms as pale, gray or blue skin, lips and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate.
Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases mainly occurred in children ages 2 years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
The FDA is continuing to evaluate the safety of benzocaine products and will update the public when it has additional information, the agency stated.
FDA acts to prevent contamination problems with Triad antiseptic products
SILVER SPRING, Md. — U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.
“We took this action to stop Triad from continuing to distribute products [that] may pose a risk to public health,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.
A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough-cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products and raw materials.
The action follows the continued failure of H & P Industries — owned and managed by the same party as Triad Group — to comply with the FDA’s current good manufacturing practice regulations.
Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.
The FDA completed its most recent inspection of H & P Industries on March 28. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility and failure to take the proper measures to ensure the quality of incoming components.
GNC closes IPO
PITTSBURGH — GNC Holdings on Wednesday announced the closing of its initial public offering of 25.9 million shares of its Class A common stock at a public offering price of $16 per share. GNC’s Class A common stock began trading Friday, April 1, on the New York Stock Exchange under the ticker symbol "GNC."
Of the shares offered, 16 million were issued and sold by the company, and 9.9 million shares were sold by selling stockholders. The shares sold by the selling stockholders included 3.4 million shares sold pursuant to the underwriters’ option to purchase additional shares.
As of early morning trading on Thursday, GNC shares were selling for $17.73.