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FDA Approves New Blood-Clotting Drug

-November 24, 2008

The Food and Drug Administration (FDA) has just approved the drug Promacta for use in the treatment of a rare immune system disease. Promacta, created and produced by the British pharmaceutical company GlaxoSmithKline, can now be prescribed to treat the bleeding associated with the incurable condition known as immune thrombocytopenic purpura (ITP).

What is ITP?
ITP causes a person's immune system to attack its own blood platelets, the cells responsible for blood clotting. As ITP ravages the body and decreases the concentrations of platelets in the blood, patients' typically experience:

• Excessive bleeding
• Bruising, even after the most minor injuries
• In more serious cases, patients may start to spontaneously bleed from their nose and/or gums.

Approximately 140,000 Americans and Europeans suffer from ITP.

While traditional treatments for ITP usually involved taking steroids, receiving blood transfusions and undergoing surgery, the approval of Promacta now gives these patients a viable option for a daily medication that will help them treat both long- and short-term effects of ITP.

Delays in FDA Approval of Promacta
Despite its recent FDA approval, Promacta has had a rocky journey in gaining acceptance for legitimate use in the U.S. In June 2008, the FDA had postponed approval of this medication, as some were concerned that it caused liver damage.

However, because it has low incidence of liver damage (and only minor damage was done in cases where the liver was affected), the FDA pushed through its approval of Promacta.

Promacta's Side Effects
In addition to possible liver damage, Promacta does have some other known side effects, including:

• diarrhea
• headache
• nausea
• vomiting
• swelling of the nose and throat (nasopharyngitis)

Because most patients only experience mild, if any, side effects when taking Promacta, the benefits of taking this new medication typically outweigh the potential health risks involved.

Other Possible Uses for Promacta
While Promacta has already been approved for use in the treatment of ITP, researchers are currently conducting studies to evaluate whether this medication can also effectively treat other conditions.

In particular, ongoing studies are evaluating whether Promacta can combat the effects of low blood platelet counts associated with Hepatitis C and chemotherapy.

Although it will take sometime before researchers can make this assessment, Promacta will be available for ITP treatment by December 1, 2008.

(Source: Forbes)

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