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Update On FDA Panel: No Change On Stent Labels

FDA
CNBC.com
FDA

As we've been writing the past two days--CNBC pharmaceuticals reporter Mike Huckman has been reporting from Gaithersburg, Md., where the U.S. Food and Drug Administration convened a panel to decide the fate of drug-coated stents. Johnson & Johnson and Boston Scientific – the two major producers of stents – have been eagerly awaiting a decision. It appears to be in their favor.

Just recently the FDA chairman announced the panel didn’t have enough data to make a “sweeping recommendation to change the label on drug-coated stents.” The chair called the data “inconsistent,” “inadequate” and “uncertain.” That means doctors can continue using them.

There has been concern that the drug-coated stents (the other stents are metallic) can cause blood clots. Stents are medical devices implanted in patients to help prevent heart attacks. Some blood thinning medications have been prescribed for drug-coated stent patients.

Huckman will have an exclusive live interview with influential panelist Dr. Steven Nissen later on “Closing Bell.”