Chattem Warned by FDA Over Icy Hot Patches
Monday, June 23, 2008
On June 17, 2008, the FDA announced that Chattem Inc. failed to inform officials about new warnings added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a recently released letter.In a warning letter to the company, the U.S. Food and Drug Administration said Chattem did not tell the FDA it was changing the wording on the product's label to help consumers avoid burns and other skin irritations after it received the complaints, the agency said in the letter dated June 6.
The company also did not report some complaints to the agency within the time period required by law, it said. It was not immediately clear how many consumers were seriously injured or otherwise harmed by the patch. FDA and Chattem officials did not return calls seeking comment.
Icy Hot is one of the companies biggest-selling brands, according to its 2007 annual report, which did not break down sales for specific products. The product line aims to help prevent muscle pain through the use of menthol a mint extract that produces a cooling sensation. The patches come in different shapes to adhere to the back and other sore body parts.
The FDA said Chattem did not have proper procedures in place to handle complaints and other problems.
It also said the product's label did not properly explain its warnings or caution that certain users such as children should not use the patches.
"The duration of use of 'up to 8 hours' raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch," the letter also said.
"The labeling needs to provide adequate directions for use with respect to the duration the device is to be applied to the patient's skin," it added.
The FDA's letter follows an inspection of the company's Chattanooga, Tennessee, plant Feb. 5 through Feb 8. Chattem recalled a variety of Icy Hot heat therapy products on Feb. 8, saying it had received consumer reports of burns and skin irritation.
FDA officials issue dozens of warning letters a year and can impose fines, product seizures and other penalties, although most are resolved without such measures.
The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems. The agency acknowledged the company had sent an earlier response about some problems but said it was inadequate.
Posted in Dangerous Drugs