In Brief

Health Canada asks the makers of products with benzocaine, a pain reliever for teething, canker sores and oral irritation, to add to labels risk statements about methemoglobinemia. The rare but serious blood condition is a reaction to the ingredient that can cause confusion and headaches and complicate breathing. The new statements warn consumers to use the smallest amount possible, when to discontinue use and to use with caution in children, among other warnings. The move comes after FDA warned last April that the ingredient can reduce the amount of oxygen carried in the blood. FDA said at the time children under 2 years should not use the ingredient unless under a health care provider’s supervision Also see "FDA Warns Of Deadly Benzocaine Risks, Label Changes Might Be On The Way" - Pink Sheet, 11 April, 2011.. In response, Church & Dwight Co. Inc. reformulated Baby Orajel Naturals without the ingredient Also see "C&D’s Naturals Could Help Retain Orajel Customers After Benzocaine Warning" - Pink Sheet, 12 September, 2011..

Perrigo Co. PLC reaches market first with a store-brand version of Mucinex (guaifenesin) 600-mg tablets, noting April 12 it...