Ed medicine daily news.

June 28, 2005 — Pfizer officials say they have found no sign of increased
blindness risk in men taking its drug Viagra.

Pfizer staff have reviewed all reports of eye-related events since the drug
has been on the market, according to a news release from the pharmaceutical
company.

“There is no evidence that Viagra causes blindness or any other serious
ocular condition,” says Joseph Feczko, MD, in the news release. Feczko is
Pfizer’s chief medical officer.

Pfizer is a WebMD sponsor.

Rare Vision Problem

“Men taking Viagra are at no greater risk for blindness than men of
similar age and health not taking the medicine,” says Feczko.

That includes a rare vision problem called erectile pill anterior ischemic
optic erectile dysfunction pill
(NAION), says Feczko. NAION is a painless swelling of the
optic nerve that causes a rapid reduction in vision.

A journal report earlier this year noted
NAION in 14 Viagra users. Most had other health problems or
structural eye problems that raised their risk of NAION. None of the men in the
study went blind, although their vision loss was permanent and reportedly
started within 24-36 hours of taking Viagra.

Pfizer: No Evidence Seen in More Than 27 Million Users

“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,” says Feczko.

“In addition, several studies specifically looking into the effect of
Viagra in the eye by Pfizer as well as independent dysfunction pill
experts found
Viagra to have no serious adverse effects on the eye,” he says.

Pfizer, FDA Discussing Label Changes

According to Pfizer’s statement,
the company is still talking to the FDA about changing Viagra’s label to
reflect rare vision problems in men who have used the drug.

The update would reflect rare reports of NAION in some men who have used the
drug.

However, the FDA concluded that no causal relationship between Viagra and
NAION has been established, says Pfizer.

Talks between Pfizer and the FDA were first reported in May.

Label Changes for Other ED Drugs?

Other erectile dysfunction drugs may also update their labels.

“It is Pfizer’s understanding that the FDA has asked that similar
information be included in the labels of all oral ED (erectile dysfunction)
medicines,” the company’s statement reads.

Patients should consult their doctors about using Viagra and follow the
drug’s prescribing information, as with any other medicine, says Pfizer.