FDA warns over Icy Hot patches
June 20th, 2008 joshua
The Food and Drug Administration has warned Chattem, Inc. for not notifying regulators with more information about its dangerous Icy Hot therapy patches.
Reuters reports Chattem released this information in a letter earlier this week. The letter states, the FDA says Chattem did not tell the government it changed its label to help consumers avoid burns and other irritations after receiving more than 168 complaints.
The FDA also says Chattem didn’t warn certain consumers against the dangers of burns derived from the patches, including warnings to children who may use them.
Earlier this year Chattem was forced to issue recalls and warnings because it received numerous complaints its pain therapy patches were tearing open and its active ingredient - a gel inside - was injuring patients. The injuries could be potentially fatal.
