Black box warning on Viagra, Cialis, Levitra & Revatio

Since it was found that at least some users of erectile dysfunction (ED) drugs like Viagra, Levitra, and Cialis were becoming blind instantly, there have been demands for recalling the drugs. Some affected people have also gone to court.

To give you a brief background, Viagra has been found to cause sudden blindness in some cases. As expected, all the manufacturers of impotence drugs denied the link and the FDA, which typically favors the pharmaceutical firms, let the companies off the hook by approving a minor change in the information on the labels. The lawsuits have also been moving slowly.

Now a consumer rights group, Public Citizen, that fights for consumer rights has petitioned that the FDA add a black box warning to the drugs. The group is also asking that Revatio - a new drug launched by Pfizer that includes the same active ingredient as Viagra, but is indicated for pulmonary hypertension - be also included in this black box warning.

Public Citizen’s concern is based, in part, on their findings that:

1. Viagra accounts for nineteen percent of the total cases of ischemic optic neuropathy (loss of vision) in the FDA’s adverse event database, more than 2-fold higher than that for the next most frequently-cited drug; and that
2. The number of cases of ischemic optic neuropathy per million prescriptions is 18-fold higher for patients taking Viagra compared with patients taking Lipitor, another drug used by people with similar risk factors.

It is highly unlikely that FDA will take any action any time soon. And it is also important to know that Viagra is not always the best option for treating impotence.

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Natrecor recall demanded again

No matter how hard Scios, the maker of Natrecor, works to keep the drug off the radar screen of scientists who doubt its safety, the medical community is not giving up. The FDA, which generally supports drug firms, has essentially ignored pleas so far from physicians and has refused to act. Natrecor has been found to damage the kidneys. Another separate study found that Natrecor increased the risk of death as well.

Many scientists are hoping that with Lester Crawford gone from the FDA, things might improve at the Agency. Writing in the New England Journal of Medicine, Dr. Jonathan Sackner-Bernstein says, "This is a terrific litmus test to see whether he is really concerned about the safety of drugs that are on the market." In April, Scios merely changed the label on Natrecor. As it was learned that Natrecor was being given to patients in cases where its safety was not tested (because the doctors benefited from every prescription), the prescription guidelines were changed.

Dr. Eric J. Topol, one of the early critics of now recalled painkiller Vioxx, has fought for the recall of Natrecor for years. He demanded that Natrecor be withdrawn in another previous article. At a showdown at the Cleveland Clinic where he works, Natrecor was almost banned at the hospital. "With all the leadership strife at FDA and the unwillingness of those people who were involved to admit the potential of being too lenient [in approving the drug], I'm not optimistic," he writes in the latest issue of the Journal.