News | January 21, 2010

Generic Drug is Safe Alternative in Treating Pulmonary Arterial Hypertension

January 21, 2010 - A recent study found generic epoprostenol is a safe and effective therapy alternative to brand name Flolan for patients suffering from pulmonary arterial hypertension (PAH).

The study was led by Richard N. Channick, M.D., director, pulmonary hypertension program, Massachusetts General Hospital and presented at in November at the American College of Chest Physicians (CHEST).

These data are significant because treatment with the brand name versions of epoprostenol can cost upwards of $70,000 annually. Use of generic drugs is a key way to reduce overall healthcare costs and leading medical societies and government agencies agree that generic drugs are identical to brand name drugs in terms of dosage form, safety, strength and quality.

Approved by the FDA in 1996, epoprostenol is an intravenous medication used to treat PAH. It is a synthetic form of a substance made by the body called prostacyclin, which promotes blood circulation and inhibits inflammation. Pulmonary hypertension develops from abnormally high blood pressure in the arteries of the lungs, which can force the heart to work harder than normal and lead to chest pain, dizziness fainting, fatigue and weakness.

Since April 2008, a generic formulation of epoprostenol (Teva Pharmaceuticals) has been available. Researchers assessed safety and early experience with this agent with a retrospective, observational review of 39 patients either being initiated with epoprostenol or being transitioned from Flolan.

Twelve patients were newly initiated on epoprostenol and 27 were transitioned from Flolan. For newly initiated patients, all were started in-hospital. Average dose upon last follow-up was 13 ng/kg/min. Typical epoprostenol side effects were noted in all patients including jaw pain, diarrhea, and flushing.

For transitioned patients, 25/27 were switched at home (rapid 1:1 transition). No change in dosing occurred with transition, although increased diarrhea (three patients) and jaw pain (two patients) were noted. There were no episodes of acute clinical deterioration, except in one patient, who experienced transient hypotension and chest pain during a three-day transition. This patient had progressive symptomatic worsening during the weeks following transition, with dosing limited by anorexia and weight loss, and was switched to Remodulin. One patient died of progressive right ventricular failure, five months after transition. Two patients were switched back to Flolan, one for worsening diarrhea and one for itching (unclear if due to epoprostenol vs. tanning bed). The remaining 23 patients remain stable with average follow-up of about four months.

The study concluded early experience suggests generic epoprostenol is safe, both as de-novo therapy and in patients being transitioned from Flolan. Whether generic epoprostenol is identical to Flolan, in safety and efficacy, however, awaits more long-term experience, researchers said.

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