Thioridazine (MELLARIL): Sales Halted In Canada

On September 8, 2005 , Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration (FDA), announced that the sale of the old antipsychotic drug thioridazine (MELLARIL) would be halted by September 30, 2005  because of safety concerns. span>

Health Canada received reports of three deaths between 2000 and 2005 possibly related to thioridazine. The most recent death occurred in February 2005. This is a significant number because Canada has about one-tenth the population of the U.S.In the U.S., only between one in 10 and one in 100 serious adverse drug reactions are ever reported to the FDA. 

Thioridazine has been sold in Canada since 1959 and was approved for sale in the U.S.in March of 1962. In has been available as a generic in Canada since 2001. Novartis, the drug’s original manufacturer, announced that the company would voluntarily discontinue Mellaril worldwide by June 30, 2005  due to safety concerns, but generic companies continued to sell the drug in the U.S. and abroad. Health Canada’s action thus puts an end to generic sales of thioridazine, whereas in the U.S.this will continue.

Thioridazine was listed as a DO NOT USE drug in the September 2000 issue of Worst Pills, Best Pills News after the FDA informed pharmacists and physicians that a black box warning was to be added to the professional product labeling for the drug. The new warning concerned the possibility of potentially fatal heart rhythm disturbances and emphasized that thioridazine was approved only for “the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs.” A black box warning is the strongest type of warning that the FDA can request a manufacturer to place in a drug’s professional product labeling.

Thioridazine is another example of a drug used to treat serious mental illness that has been withdrawn from markets in other countries for safety reasons but remains on the market in the U.S. Nefazodone (SERZONE), a drug used to treat major depressive disorder, can cause life-threatening liver damage and was banned in Canada effective November 28, 2003. The manufacturer of brand name Serzone stopped selling the drug in the U.S., but generic versions are still available here. Public Citizen’s Health Research Group petitioned the FDA on two occasions in 2003 to remove this dangerous drug from the market.  

The FDA’s lack of action in removing thioridazine and nefazodone from the U.S.market is unacceptable. It appears that the FDA is protecting drugs, and drug companies, not patients. Though there are no totally safe drugs, there are safer alternatives to both thioridazine (e.g., haloperidol) and nefazodone (e.g., nortriptyline.)  

The FDA and others have apparently bought the pharmaceutical industry’s “consumerism” message hook, line and sinker. The industry argues that the public wants more drug treatment options. It contends that generic drugs such as thioridazine and nefazodone should stay on the market for this reason, even after safety problems have forced their original manufacturers to abandon them. Consumers want better drugs, not more of the same.

What You Can Do

Do NOT stop taking this drug without the advice of your physician. If you are taking thioridazine, consult your prescribing physician as soon possible about safer alternatives such as haloperidol.