Thursday, December 10, 2009

FDA Okays Injectable Revatio

Pfizer announced in late November that the Food and Drug Administration has approved Revatio (sildenafil) for injection. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) available in both oral and intravenous form.

Revatio is used to treat adults with pulmonary arterial hypertension. This helps the patient improve their exercise ability and delays the worsening of conditions. Pulmonary arterial hypertension affects around 100,000 men and women around the world. It is a rare, progressive, and incurable and is characterized by high blood pressure in the pulmonary arteries. This leads to heart failure and death.

Revatio injections are currently available for patients already taking the drug in pill form, but are unable to do so for a short time.

Revatio Side Effects and Safety Information

Revatio was approved by the FDA in June 2005 and by the European Medicines Agency (EMEA) in November 2005. It contains the same medicine as Viagra, however, patients are told to never take the two drugs together. Patients should also never take Revatio with drugs containing nitrates.

Revatio should not be taken by patients who have had blockage of veins in their lungs (pulmonary veno-occlusive disease). Patients who feel dizzy, have chest pains, or any other kinds of discomfort are told to speak with their doctors. Patients with low blood pressure or blood circulation should discuss taking Revatio with their physician.

Revatio may increase the chance of nosebleeds in patients who are taking vitamin K. However, patients who have stomach ulcers or bleeding problems should tell their doctor since it is unknown how the drug will affect these individuals.

Patients who have been taking PDE5 inhibitors, including Revatio, have reported a sudden decrease or complete loss in their hearing. Men who take PDE5 inhibitors for erectile dysfunction, including Viagra, have reported a sudden decrease or complete loss of vision in one or both eyes.

The most common side effects of taking Revatio are headaches, flushing, upset stomach, nosebleed, and trouble sleeping.

If you or a loved one has been injured by taking Revatio, please contact the experienced pharmaceutical litigation attorneys at Sclichter, Bogard & Denton. We serve clients nationwide including Kansas City, Missouri.

posted by Erica at 11:46 AM

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