Revatio, a form of Viagra, approved for PAH
Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension (PAH), a rare, aggressive and life-shortening vascular disease. Sildenafil citrate is the active ingredient in Viagra, Pfizer's erectile dysfunction medication used by more than 26 million men worldwide. It is important to point out that Viagra is currently being investigated by the FDA because of its linkage to sudden blindness in some men. It was, therefore, quite surprising that the US FDA will approve Viagra for another use while the investigation is still going on and calls for Viagra recall are mounting.
PAH is characterized by dangerously high pressure in the blood vessels that lead from the heart to the lungs. It is estimated to affect approximately 100,000 people worldwide. Symptoms include difficulty breathing, dizziness and fatigue. Left untreated, patients have an average survival time of less than three years from the time of diagnosis.
The FDA granted Revatio a priority review. This type of approval process has come under a lot of criticism lately since the drug firms abuse the system to get the drug approved faster without adequate testing. While the approval is contingent upon further testing but that rarely gets done and the FDA has no enforcement power. In any case, FDA has been accused by consumer rights groups of putting the interests of drug firms ahead of American people. (Related article: FDA's accelerated drug approval process is broken)
Revatio is the first oral treatment for PAH to be approved for patients with an early stage of the disease, allowing physicians to treat patients earlier in this progressive disorder. The most common side effects of Revatio are headache, dyspepsia, flushing, epistaxis, and insomnia. The Revatio 20 mg pill is white and round to distinguish it from Viagra's blue diamond-shaped pill for erectile dysfunction. Pfizer expects Revatio to be available in retail pharmacies in mid-July.
Revatio is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. The efficacy of Revatio has not been evaluated in patients currently on bosentan therapy. The use of Revatio or Viagra and organic nitrates in any form, at any time, is contraindicated. Side effects were similar to the established safety profile of Viagra used for the treatment of ED.
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