MADISON, N.J., Jan. 17 /PRNewswire/ -- Wyeth Consumer Healthcare, a division of Wyeth (NYSE: WYE), supports today's U.S. Food and Drug Administration's (FDA) decision to no longer recommend use of over-the-counter cough and cold products in children under age two.
"This decision is consistent with our voluntary removal in October 2007 of over-the-counter infant cough and cold products from the global market to help reduce dosing errors and overdoses in children who are most vulnerable to misuse of these medicines," says Cavan Redmond, President, Wyeth Consumer Healthcare.
Since October 2007, the Company has worked with retailers, health care
professionals and the FDA to ensure that parents have the information they
need to adapt to the new guidelines regarding use of these medicines in
children under age two.
Wyeth Consumer Healthcare is also taking the following actions:
-- Communicating to healthcare professionals to no longer recommend
over-the-counter cough and cold products for children under age two
-- Changing labels for products that have dosing instructions for
children under age two to clarify that over-the-counter cough and cold
medicines should not be used for children under age two
-- Updating health care professional dosing charts to reflect the new "do
not use" instructions for children under age two
-- Adding the "do not use" instructions for children under age two to
marketing materials for Robitussin and Dimetapp products
It is important to note that Wyeth believes over-the-counter cough and cold products are safe for use in children ages two and older, as well as in adults, when used according to label directions. Marketplace surveillance data analyzed by the Rocky Mountain Poison and Drug Center in Denver, Colorado confirm that risks are minimal when these medicines are used at recommended doses by children age two and older. The data also confirm that the vast majority of safety concerns are with product misuse by children age two and younger.
Wyeth Consumer Healthcare is awaiting final recommendations from the FDA for use of over-the-counter cough and cold products in children ages two to eleven. The Company will continue to take all appropriate actions to support the safe and effective use of cough and cold medications.
About Wyeth Consumer Healthcare
Wyeth Consumer Healthcare, a division of Wyeth, is one of the world's leaders in the development, manufacturing and marketing of non-prescription medicines, vitamins and nutritional products, including established brands such as Advil(R), Centrum(R), ChapStick(R), Dimetapp and Robitussin. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
|SOURCE Wyeth Consumer Healthcare|
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