Bayer Has Not Decided Whether to Add NAION Warning for Levitra
On June 27, 2005 Pfizer Inc. issued a press release asserting that there is no evidence of any increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), leading to blindness, among patients taking Viagra, Pfizer's erectile dysfunction (ED) drug.
Joseph Feczko, Pfizer's chief medical officer, was quoted in the Viagra press release as stating:
There is no evidence that Viagra causes blindness or any other serious ocular condition.... 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.
The Pfizer press release also stated that the drug company is currently negotiating with the FDA about making revisions to the Viagra package insert, or warning label, to inform doctors and patients about the development of NAION, and blindness, in some Viagra users.
Pfizer said in this press release that it believes the FDA has asked other drug companies to add the NAION and blindness information to the warning labels for their respective ED drugs. For market share as concerns ED drugs, or impotence drugs, Pfizer's Viagra competes with Cialis, sold by Eli Lily & Co. and Icos Corp., as well as Levitra, which is co-promoted by GlaxoSmithKline and Bayer AG.
The day after Pfizer's Viagra press release, Bayer said it had not decided, yet, whether new warning language about NAION and blindness will be added to the package insert for their impotence drug. Levitra.
Meanwhile, Lilly and Icos updated the Cialis warning label last month to add language regarding NAION and blindness.
Previously, the FDA has said while the agency has received 43 reports of NAION and blindness among men who took ED or impotence drugs, the FDA has concluded there is no evidence of a link between the ED drugs and blindness.
Read more about reports of NAION and blindness among users of Viagra and other ED, or impotence, drugs.
(Posted by: Tom Lamb)