HighSchool Fan
06-28-2005, 03:17 PM
No proof Viagra causes blindness
NEW YORK Pfizer Inc. said a review concluded that Viagra doesn't increase patients' risk of blindness but that it is still working with federal regulators to update the drug's label to reflect rare reports of vision loss.
Last month, the U.S. Food and Drug Administration said it had 38 reports of blindness caused by a a condition called NAION or non-arteritic anterior ischemic optic neuropathy among users of Viagra.
But Pfizer said it conducted a review of all post-marketing ocular event reports has concluded that there is no evidence of increased risk of blindness among patients taking Viagra.
While the FDA has concluded that no causal relationship between Viagra and NAION has been established, Pfizer has agreed to include on the Viagra label that these reports exist in order to inform physicians and patients.
After more than 10 years of rigorous clinical study and worldwide safety monitoring of a medicine used by more than 27 million men, there is no evidence to suggest a link between Viagra and blindness or other serious ocular events, said Joseph Feczko, Pfizer's chief medical officer. In addition, several studies specifically looking into the effect of Viagra in the eye by Pfizer as well as independent ophthalmologic experts found Viagra to have no serious adverse effects on the eye.
Pfizer said it is the company's understanding that the FDA has asked that similar information be included in the labels of all oral erectile dysfunction medicines. The FDA reported there were instances of NAION among those taking Cialis, which is made by Eli Lilly & Co. and ICOS Corp. as well as Levitra, which is marketed by Bayer AG, GlaxoSmithKline PLC and Schering-Plough Corp.
Bayer said Tuesday it has not yet decided if it will include new label information for Levitra.
Helmut Schaefers, a spokesman for Leverkusen, Germany-based Bayer AG, said the company was working with the FDA to investigate the claims.
We are in the process of evaluating the data and reviewing the analyses, he said. We have already conducted exhaustive studies involving 60,000 patients and there has never been one case of sudden blindness.
NEW YORK Pfizer Inc. said a review concluded that Viagra doesn't increase patients' risk of blindness but that it is still working with federal regulators to update the drug's label to reflect rare reports of vision loss.
Last month, the U.S. Food and Drug Administration said it had 38 reports of blindness caused by a a condition called NAION or non-arteritic anterior ischemic optic neuropathy among users of Viagra.
But Pfizer said it conducted a review of all post-marketing ocular event reports has concluded that there is no evidence of increased risk of blindness among patients taking Viagra.
While the FDA has concluded that no causal relationship between Viagra and NAION has been established, Pfizer has agreed to include on the Viagra label that these reports exist in order to inform physicians and patients.
After more than 10 years of rigorous clinical study and worldwide safety monitoring of a medicine used by more than 27 million men, there is no evidence to suggest a link between Viagra and blindness or other serious ocular events, said Joseph Feczko, Pfizer's chief medical officer. In addition, several studies specifically looking into the effect of Viagra in the eye by Pfizer as well as independent ophthalmologic experts found Viagra to have no serious adverse effects on the eye.
Pfizer said it is the company's understanding that the FDA has asked that similar information be included in the labels of all oral erectile dysfunction medicines. The FDA reported there were instances of NAION among those taking Cialis, which is made by Eli Lilly & Co. and ICOS Corp. as well as Levitra, which is marketed by Bayer AG, GlaxoSmithKline PLC and Schering-Plough Corp.
Bayer said Tuesday it has not yet decided if it will include new label information for Levitra.
Helmut Schaefers, a spokesman for Leverkusen, Germany-based Bayer AG, said the company was working with the FDA to investigate the claims.
We are in the process of evaluating the data and reviewing the analyses, he said. We have already conducted exhaustive studies involving 60,000 patients and there has never been one case of sudden blindness.