Novartis sued in California over kids’ cough medicine

A California mother has sued drug maker Novartis AG in what the company believes to be the first proposed class action involving its Triaminic children’s cough and cold medicines since overdose fears prompted a recall of the drugs.

The lawsuit, filed on Tuesday in U.S. District Court in Los Angeles, said several studies have shown deaths and serious injuries linked to over-the-counter children’s cold remedies.

As a result, Novartis “either knew ... or reasonably should have known that their cough and cold products were ineffective and dangerous when used by children under the age of six,” the lawsuit said.

A Novartis spokeswoman said the company had not seen the lawsuit and had no comment on it. The company, which recalled Triaminic oral infant cough and cold medicines late last year, said it believed the lawsuit is the first to bring claims involving the drugs.

The lawsuit was brought by Kelly Carter, who dosed her 4-year-old son with Triaminic Daytime Cough & Cold in 2007. It was not immediately clear from the lawsuit whether or how the drug harmed Carter’s son. Her attorney could not be reached for comment.

Novartis sells a number of products under the Triaminic brand. The lawsuit alleges that Americans spend more than $2 billion annually on over-the counter cough and cold remedies for children.

In October, 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 death and serious injury in rare instances.

The group stressed that the medications are safe when used as directed.

U.S. Food and Drug Administration reviewers have recommended that 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 U.S. children under the age of 12 to emergency rooms every year, mostly for overdoses.