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March 27,  2003

FDA Approves New Drug to Combat Nausea and Vomiting for Cancer Patients Getting Chemotherapy

(SafetyAlerts) - The Food and Drug Administration (FDA) today announced the approval of a new drug called Emend (aprepitant), to be used in combination with other anti-nausea and anti-vomiting drugs for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy known to cause these problems, including high-dose cisplatin.

Emend is the first FDA approved treatment that prevents the delayed nausea and vomiting symptoms that many patients experience greater than 24 hours after receiving chemotherapy. Chemotherapy is often very distressing for cancer patients due to severe nausea and vomiting. These symptoms can be severely debilitating, often resulting in patients' refusing further courses of chemotherapy or in serious limitations on their lifestyle.

"This new drug is important in the management of chemotherapy induced nausea and vomiting. It should improve cancer patients' quality of life, as well as their ability to tolerate these treatments," stated Commissioner Mark McClellan, M.D., Ph.D.

In 2002, the American Cancer Society found that over 1,284,900 new cases of cancer were diagnosed in the United States. Emend can reduce nausea associated with chemotherapy treatments used to treat cancers such as lung cancer, head and neck cancer, and some female cancers.

Emend is part of a three-drug therapy that works with other drugs to treat nausea and vomiting. It reduces nausea and vomiting in a new way by blocking receptors in the brain called NK1 receptors.

FDA based its approval of Emend on the results of two well-controlled studies that included over 1000 cancer patients receiving chemotherapy that causes severe nausea and vomiting. In these studies fewer patients had symptoms of nausea and vomiting when Emend was part of their treatment compared to patients who received standard nausea and vomiting medicines.

Emend may interact with some drugs, including some chemotherapies, birth control pills, blood thinners, and other drugs. Emend may reduce the effectiveness of oral contraceptives (birth control pills). Women of child - bearing years should use another form of birth control when using Emend.

Patients being treated with blood thinners such as warfarin and Coumadin will need to have their blood tested after the completion of their 3-day regimen that includes Emend with each chemotherapy cycle to see if their blood thinning medicine's dose needs to be changed.

Patients should report to their doctor the use of any other prescription or non-prescription medication or herbal product because these may interact with Emend.

Emend is manufactured by Merck & Co., Inc., of Whitehouse Station, N.J.


Source: FDA

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