Watchdogs take aim at your painkillers
June 30, 2009
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Theresa Boyle
STAFF REPORTER
A crackdown on acetaminophen is brewing as U.S. regulators consider lower dosages or even pulling NyQuil and other popular medications off the shelves.
The Food and Drug Administration fears that consumers are overdosing by pairing pure acetaminophen medication, such as Tylenol, with cough and cold medications that also contain the drug, plus other ingredients.
Acetaminophen is the leading cause of liver damage in the U.S., sending 56,000 people to the emergency room annually.
A Health Canada representative is attending an FDA meeting in Maryland where 35 experts are discussing ways to prevent such overdoses.
Asked whether Canada is considering a similar ban, Health Canada spokesperson Christelle Legault would only say last night that the department will this summer conduct an analysis of comments and information presented to the FDA.
She pointed out that Health Canada has proposed new labelling requirements for products containing acetaminophen, including a warning statement about the potential for liver toxicity and a caution that individuals are at greater risk if they suffer serious kidney or liver disease or drink alcohol. Health Canada hopes to finalize the new labelling standard in September, Legault said.
U.S. drugmakers were ordered by the FDA in April to have bolder warning labels and agreed to comply.
The agency has called in outside advisers to discuss tougher regulations at the two-day meeting, which wraps up today. It is particularly concerned about the increasing number of cough and cold products, such as NyQuil and Theraflu, called "combination" remedies because they contain acetaminophen and other ingredients. A ban is being considered on both over-the-counter and prescription combination products.
Makers of acetaminophen, including Johnson & Johnson and Procter & Gamble, are urging the FDA to keep these products on the market and are instead calling for a major effort to warn consumers about the potential for liver damage. A total ban on combination products would seriously eat into their sales.
Another option being considered by the agency is lowering the dosage in some products.
Gerry Harrington, director of public affairs for Nonprescription Drug Manufacturers Association of Canada, acknowledged that any changes made in the States could have an impact here.
With files from Associated Press
Toronto Star