A proposed class action lawsuit has been filed against the drug maker alleging Triaminic children's cough and cold medicines are linked to overdose and death. The lawsuit was filed in US District Court in Los Angeles and claims Novartis either knew or reasonably should have known that their cough and cold products were ineffective and dangerous when given to children under the age of six.
Triaminic oral infant cough and cold medicines were recalled in October 2007 and the Consumer Healthcare Products Association, a trade group representing makers of over-the-counter medicines, said overdoses of oral infant cough and cold medicines have led to deaths and serious injuries. The US FDA recommended over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not for very young children.
According to a recent report by the Centers for Disease Control and Prevention, over-the-counter cough and cold drugs send an estimated 7,000 US children under the age of 12 to emergency rooms every year, mostly for overdoses.