FDA OKs Return of 'Marijuana' Drug

Drug, Called Cesamet, Treats Nausea and Vomiting From Chemo

Medically Reviewed by Charlotte E. Grayson Mathis, MD on May 18, 2006
From the WebMD Archives

May 18, 2006 -- The FDA has given marketing approval to the drug Cesamet, which contains a synthetic cannabinoid. Cannabinoids are the active ingredients in marijuana.

Cesamet treats chemotherapy-related nausea and vomiting in cancer patients who don’t adequately respond to conventional treatments for nausea and vomiting. The drug comes in capsules taken by mouth.

The FDA originally approved Cesamet in 1985 when the drug was made by Eli Lilly and Company. Lilly discontinued the drug in 1989 for commercial reasons, according to news reports.

Valeant Pharmaceuticals International bought Cesamet from Lilly in 2004 and currently markets the drug in Canada. Valeant has revised the drug’s labeling and expects to launch Cesamet in the U.S. “in the next several weeks following approval,” states a Valeant news release.

About the Drug

The drug’s label states that Cesamet, “like other cannabinoids, has complex effects on the central nervous system” and that the drug may work by interacting with cannabinoid receptors (the CB1 receptor) in the brain.

According to Valeant’s news release, Cesamet’s safety and effectiveness was tested in 11 clinical trials totaling more than 300 cancer chemotherapy patients. Five trials compared Cesamet with another drug called Compazine (prochlorperazine) that doesn’t contain cannabinoids. Compazine is a common medication for nausea and vomiting, especially for cancer patients. The other six studies compared Cesamet with sugar pills (placebo), which contained no medication.

In all but one study, Cesamet came out on top in all statistical comparisons, meaning that patients using Cesamet had fewer vomiting episodes and less severe nausea, states Valeant.

Side Effects

“During clinically controlled trials of Cesamet, virtually all patients experienced at least one adverse reaction,” states Valeant’s news release.

Patients in those trials who took Cesamet “reported a higher incidence of adverse effects,” states the drug’s label. “The most frequent were drowsiness, vertigo, dry mouth, and euphoria,” the label states. “However, most of these adverse effects occurring with Cesamet were of mild to moderate severity.”

Cesamet is classified as a “Schedule II” drug, meaning it has a “high potential for abuse,” states the drug’s label, which includes these notes:

  • Cesamet prescriptions should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
  • Cesamet isn’t intended as a first-line treatment for chemo-related nausea and vomiting.
  • Prescribers should monitor patients for signs of excessive use, abuse, and misuse.
  • Patients should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while taking Cesamet.
  • Cesamet shouldn’t be taken with alcohol, sedatives, hypnotics, or other psychoactive substances.
  • Patients taking Cesamet should be supervised by a responsible adult, especially during initial use and dose adjustments.

The label also states that Cesamet should be used with caution in these groups:

  • Patients with current or previous psychiatric disorders including manic depressive illness, depression, and schizophrenia. Cesamet may unmask these conditions’ symptoms.
  • Patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use
  • Pregnant patients, nursing mothers, or pediatric patients. Cesamet hasn’t been studied in these groups.
  • Elderly patients and those with high blood pressure or heart disease. Cesamet may raise heart rates and cause postural hypotension (low blood pressure upon standing).


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SOURCES: FDA: “Cesamet: Label and Approval History.” FDA: “Cesamet: Label Information.” News release, Valeant Pharmaceuticals International. Associated Press.

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