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Canada Halts Sales of Thioridazine

WARNING: DO NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

FDA BLACK BOX WARNING: Thioridazine has been shown to prolong the QTc interval in a dose-related manner, and drugs with this potential, including thioridazine, have been associated with torsades de pointestype arrhythmias and sudden death. Due to its potential for significant, possibly life-threatening, proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs.

On September 8, 2005, Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration (FDA), announced that the sale of all forms of the old antipsychotic drug thioridazine (MELLARIL) will be halted by September 30, 2005 because of safety concerns. This action was taken because manufacturers of the drug have failed to provide convincing evidence that thioridazine is safe to use. The questions about safety involve cases of heart rhythm disturbances that can be life-threatening.

Between 2000 and 2005, Health Canada received reports of three deaths 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 about one to 10 percent of 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 1962. Novartis, the drugs 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 because there is no indication that the FDA plans to remove generic thioridazine from the market

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 drugs 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 which 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 Citizens Health Research Group petitioned the FDA on two occasions in 2003 to remove this dangerous drug from the market.

The FDAs lack of action in removing thioridazine and nefazodone from the U.S. market is difficult to fathom. 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 (for example, haloperidol) and nefazodone (for example, nortriptyline.)

The FDA, and others, have apparently bought, the pharmaceutical industrys 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 or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

If you are taking thioridazine, consult your prescribing physician as soon possible about safer alternatives such as haloperidol.

*Above Information provided by www.citizen.org

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