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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene

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From: DewDiligence_on_SI	4/7/2006 6:39:34 PM
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Macugen Label Amended to Include Allergic Reaction yahoo.reuters.com >> Pfizer, OSI report rare eye drug sensitivity Fri Apr 7, 2006 4:22 PM ET WASHINGTON, April 7 (Reuters) – Pfizer Inc. <PFE> and OSI Pharmaceuticals Inc. <OSIP> have reported rare cases of serious allergic reactions with use of their eye drug Macugen along with other medications, the U.S. Food and Drug Administration said on Friday. The companies earlier this month notified doctors about the reactions, which included allergic swelling around the eyes or lips and other anaphylactic symptoms, the FDA said. Information about the reports has been added to the drug's label, the companies said. Pfizer shares closed down 1.6 percent, or 40 cents, at $24.69 on the New York Stock Exchange. Shares of OSI were off 3.5 percent, or $1.10 cents, to close at $30.02 on the Nasdaq. The drugmakers said the cases occurred after the injectable drug was approved in the United States in 2004. The sensitivity occurred when Macugen was given along with other medications as part of the injection procedure. "A direct relationship to pegaptanib (Macugen) or any of the various medications administered as part of the injection preparation procedure or other factors has not been established in these cases," the March 6 letter said. The FDA posted the letter to its Web site on Friday. The companies also warned doctors to evaluate patients for a history of hypersensitivity reactions before giving the drug, which is approved to treat age-related vision loss known as macular degeneration. <<

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