March 27, 2003
FDA Approves New Drug to Combat
Nausea and Vomiting for Cancer Patients Getting Chemotherapy
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
Emend is manufactured by Merck & Co., Inc., of Whitehouse Station, N.J.