Wyeth Consumer Healthcare Supports U.S. Food and Drug Administration Decision for Over-the-Counter Cough and Cold Medications in Children under Two Years of Age
"This decision is consistent with our voluntary removal in October 2007 ofover-the-counter infant cough and cold products from the global market to helpreduce dosing errors and overdoses in children who are most vulnerable tomisuse of these medicines," says Cavan Redmond, President, Wyeth ConsumerHealthcare.
Since October 2007, the Company has worked with retailers, health careprofessionals and the FDA to ensure that parents have the information theyneed to adapt to the new guidelines regarding use of these medicines inchildren under age two.
It is important to note that Wyeth believes over-the-counter cough andcold products are safe for use in children ages two and older, as well as inadults, when used according to label directions. Marketplace surveillancedata analyzed by the Rocky Mountain Poison and Drug Center in Denver, Coloradoconfirm that risks are minimal when these medicines are used at recommendeddoses by children age two and older. The data also confirm that the vastmajority of safety concerns are with product misuse by children age two andyounger.
Wyeth Consumer Healthcare is awaiting final recommendations from the FDAfor use of over-the-counter cough and cold products in children ages two toeleven. The Company will continue to take all appropriate actions to supportthe 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'sleaders in the development, manufacturing and marketing of non-prescriptionmedicines, vitamins and nutritional products, including established brandssuch as Advil(R), Centrum(R), ChapStick(R), Dimetapp and Robitussin. Wyeth isone of the world's largest research-driven pharmaceutical and health careproducts companies. It is a leader in the discovery, development,manufacturing and marketing of pharmaceuticals, vaccines, biotechnologyproducts and non-prescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts areforward-looking statements based on current expectations of future events andare subject to risks and uncertainties that could cause actual results todiffer materially from those expressed or implied by such statements. Theserisks and uncertainties include the inherent uncertainty of the timing andsuccess of, and expense associated with, research, development, regulatoryapproval and commercialization of our products, including with respect to ourpipeline products; government cost-containment initiatives; restrictions onthird-party payments for our products; substantial competition in ourindustry, including from branded and generic products; data generated on ourproducts; the importance of strong performance from our principal products andour anticipated new product introductions; the highly regulated nature of ourbusiness; product liability, intellectual property and other litigation risksand environmental liabilities; uncertainty regarding our intellectual propertyrights and those of others; difficulties associated with, and regulatorycompliance with respect to, manufacturing of our products; risks associatedwith our strategic relationships; economic conditions including interest andcurrency exchange rate fluctuations; changes in generally accepted accountingprinciples; trade buying patterns; the impact of legislation and regulatorycompliance; risks and uncertainties associated with global operations andsales; and other risks an
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