One week after the nation's largest over-the-counter drug makers pulled cold medicines designed for infants off the market, companies will make the case Thursday that the treatments are safe and effective for toddlers.
The Food and Drug Administration will ask a panel of outside experts Thursday and Friday whether popular cold medicines are medically appropriate for young children. After a review of data, FDA scientists recently said the treatments should not be given to children under two because of the risk of accidental overdose. The agency will ask its advisers whether current labeling advising parents to "consult your physician" should be replaced with the instructions "do not use in children under two."
In response to the safety concerns, Johnson & Johnson, Wyeth and others withdrew products last week that target infants. However, public health advocates are expected to tell FDA that the companies haven't gone far enough.
The American Academy of Pediatrics, whose president will speak at the meeting, has said there is no evidence cold medicines are effective in children up to six years old -- and product labeling should state that. The pediatrics group and others also want FDA to prohibit companies from using images of toddlers to market their cold medications.
Scientists from Johnson & Johnson and other industry representatives are expected to argue that the treatments are effective in toddlers, while acknowledging that additional studies are needed to prove this.
FDA agreed to have its panel of experts review data on cold medicines at the request Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.
FDA is not required to follow the recommendations of its panelists, though it usually does.
Source: Business Week, 10/18/07
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