http://www.miami.com/mld/miamiherald/business/national/11-
754172.htm

Posted on Fri, May. 27, 2005

FDA looking into blindness-Viagra link

LAURAN NEERGAARD

Associated Press

WASHINGTON - Federal health officials are examining rare
reports of blindness among some men using the impotence drugs
Viagra and Cialis, a disclosure that comes at a time when the
drug industry can ill afford negative publicity about another
class of blockbuster medicines.

The Food and Drug Administration still is investigating, but
has no evidence yet that the drug is to blame, said
spokeswoman Susan Cruzan.

This type of blindness is called NAION, or non-arteritic
anterior ischemic optic neuropathy. It can occur in men who
are diabetic or have heart disease, the same conditions that
can cause impotence and thus lead to Viagra use.

The FDA has 42 reports of the blindness, 38 among users of
Viagra and four among users of Cialis. There were no cases
reported among users of Levitra, the third impotence drug.

"We take this seriously," said FDA's Cruzan.

The FDA is in discussions about the reported cases with the
manufacturers of the three drugs in case there is a problem
with the class of medication and to see if changes need to be
made to their labels.

Eli Lilly & Co., which manufactures Cialis, refers to vision
problems as an uncommon side effect, including seeing a blue
tinge or having difficulty telling the difference between blue
and green. "These are not all the side effects of Cialis," it
says on its Web site.

Viagra manufacturer Pfizer Inc. also refers on its Web site
to some vision issues: "Less common are bluish or blurred
vision, or being sensitive to light. These may occur for a
short time." That language had been available before the
current inquiry.

Pfizer spokesman Daniel Watts confirmed Friday that the
drugmaker was in discussions with the FDA about adding a
disclosure to Viagra's label to say that in rare cases, men
taking Viagra had developed blindness. However, he said there
is no proof that Viagra caused the blindness. He said that men
who take Viagra often have high blood pressure and high
cholesterol, which are also associated with the conditions
that can cause blindness.

Levitra is sold in the United States by GlaxoSmithKline PLC
and Bayer AG.

Viagra was approved by the government in 1998. It may aid in
the treatment of enlarged hearts that can result from high
blood pressure, tests on animals indicate.

Levitra was approved in August 2003, and Cialis in November of
that year.

There have been no reports connecting Levitra to
blindness, said Michael Flemming, a spokesman for
GlaxoSmithKline PLC. "We are confident about the safety of
our product," said Flemming.

Levitra, Cialis and Viagra all work in the same fashion,
but Flemming said that doesn't mean they all have the same
side effects. "Every drug is different. Every drug is
unique," he said.

Analyst Jason Napodano of Zacks Investment Research Inc. said
he doesn't think Viagra sales will stumble because of the new
reports because the number of cases is so small. "It is too
early to say that Viagra is causing this (the blindness) and
look how small the numbers are," he said.

Viagra, approved to treat erectile dysfunction, should not be
used by men with heart conditions whose doctors have warned
them not to have sex. Also, patients taking drugs that contain
nitrates have been warned not to take Viagra because of
sudden, unsafe drops in blood pressure.

The drug's label also warns of erections lasting longer than
four hours, painful erections lasting longer than six hours,
headache, flushed skin and vision problems.

Pfizer Inc. said in its most recent quarterly filing with the
Securities and Exchange Commission that sales of the drug rose
5 percent - to $438 million in the first quarter of the year.
Pfizer also said at the time that Viagra had a 68 percent
worldwide market share.

Viagra sales have been under pressure from new competitors
Cialis and Levitra, with revenue sinking 11 percent last year
to $1.68 billion from $1.88 billion. Pfizer shares fell in
early trading on the New York Stock Exchange.

Doctors and patients have become increasingly wary of the
downsides of prescription drugs after Merck & Co. yanked its
pain reliever Vioxx from the market last year because of its
potentially lethal side effects.

Merck potentially faces thousands of lawsuits over Vioxx and
analysts have estimated its liability may reach $18 billion.

Pfizer was asked to remove its pain reliever Bextra from the
market because of its side effects and sales of its other
arthritis drug Celebrex are falling. Vioxx, Celebrex and
Bextra all fall into a category of drugs known as Cox-2
inhibitors.

Industry critics have been demanding that drug companies
conduct more post-marketing studies in order to do a better
job of discovering side effects once drugs hit the market.

For more than two decades, Americans have mostly pressed for
quicker approval of what they hope can be lifesaving drugs for
such diseases as AIDS and cancer. But many now are wondering
if medicines - a $200 billion industry annually - are coming
out too fast and doing too much harm.

Viagra also is at the center of controversy over Medicaid's
payment for prescriptions of the drug to convicted sex
offenders in New York and other states.

-------

TC