Pesky Heny Waxman and Cold Medicine for Children

Another potential regulatory problem for Pharma. What will happen?


http://biz.yahoo.com/ap/071005/cold_medications_waxman.html?.v=2


Waxman Criticizes Cold Medicine Makers
Friday October 5, 6:11 pm ET
By Matthew Perrone, AP Business Writer
Waxman Wants Over-The-Counter Cold Medication Makers to Add Warning Labels for Children

WASHINGTON (AP) -- The chairman of a key watchdog committee in Congress is asking makers of over-the-counter cold medicine to voluntarily relabel the products with a warning not to give the drugs to anyone under two years old.

...

The FDA is reviewing the safety of the drugs at the request of Baltimore city officials, including the city's commissioner of health, Joshua Sharfstein, a former staffer in Waxman's office. The officials made the request after a study showed roughly 900 children aged 4 or younger who live in Maryland overdosed on these medications in 2004.

After reviewing reports of side effects over the last four decades, FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children's deaths connected with antihistamines, which are used to treat runny noses.

At a meeting set for Oct. 18-19, the agency will consider whether to formally request labeling changes.