FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-29                        Print Media:        301-82762-42
May 21, 1998                  
                              Consumer Media:     800-532-4440

FDA Approves New Heart Medicines

FDA has approved new "anti-platelet" drugs for people with heart disease. The agents, Integrilin, Aggrastat and ReoPro, have been approved to reduce the incidence of clot formation during cardiac care procedures, and ultimately to reduce the heart attacks and need for additional urgent procedures that can result. The following can be used to answer questions:

Blood platelets help to form clots. This process, while helpful when a blood vessel is injured and bleeding, can be harmful when new clots block important blood vessels and interfere with normal blood flow. Disruption of the cholesterol plaque that builds up in blood vessels can occur during various cardiologic procedures (i.e. angioplasty, stent placements, etc.). This disruption can then initiate the natural clotting mechanism, just as if the vessel itself had been injured.

This kind of clotting can interfere with the success of a given cardiologic procedure, by resulting in new clots that interfere with blood flow and lead to symptoms resembling those of a heart attack. Some patients who experience these symptoms go on to have a full heart attack and/or to require emergency procedures.

FDA has approved three medications that reduce platelets' response to the signals that trigger this problematic clot formation, ultimately preventing heart attacks and the need for these emergency procedures.

Two of the three medications (Aggrastat and Integrilin) are approved for use in acute coronary syndrome (whether or not the patient is expected to undergo therapeutic procedures), and two of the three (ReoPro and Integrilin) are approved for use around the time of balloon angioplasty and related procedures (whether done electively or in the setting of acute coronary syndrome). Patients who took these drugs in clinical trials suffered fewer heart attacks and required fewer urgent procedures. The clinical trials included several thousand patients but did not provide evidence to evaluate the effect on long-term survival. The only important side effect from taking these new drugs that has been observed is excessive bleeding.

Manufactured by Centocor B.V. (Leiden, The Netherlands), ReoPro (abciximab) was approved Dec. 22, 1994. Eli Lilly and Co. of Indianapolis distributes this drug in the United States.

Aggrastat (tirofiban) is manufactured and distributed by Merck and Co. of West Point, Pa., and was approved May 14, 1998. Lastly, Integrilin (eptifibatide) was approved on May 18, 1998. It is manufactured by COR Therapeutics of San Francisco and will be distributed by Key Pharmaceuticals Inc. of Kenilworth, N.J.

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