Waxman Criticizes Cold Medicine Makers
Friday, October 05, 2007
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.Rep. Henry Waxman, D-Calif., has stopped short of asking the Food and Drug Administration to mandate an immediate label change.
However, he did send a letter this week to a trade group representing companies like Johnson & Johnson, Novartis AG and Procter & Gamble Co. that make the widely used drugs, asking for voluntary label revisions.
His letter comes days after the FDA made a nonbinding recommendation that the drugs should not be taken by very young children. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers and many doctors say they are safe to use.
In his Oct. 3 letter, Waxman questioned why companies haven't already pulled products with the existing label off the market, citing Johnson & Johnson's Tylenol Infants' Drops Cold & Cough Plus as an example of a medicine that should be removed from store shelves. Similar treatments feature pictures of babies and come in dropper form, suggesting they are specially formulated for youngsters.
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.
The Consumer Health Care Products Association said last week it agrees with limiting the use of the medications to children above the age of 2. In a response to Waxman's letter, the group said Wednesday its member companies are working to adopt the limited labeling.
"Member companies are no longer advertising or promoting these medicines for infants," said the trade group.
In his letter, Waxman requests CHPA explain what steps it will take to sure the medications are not used in infants and toddlers.
Posted in Dangerous Drugs