Case Studies of Troglitazone and Cisapride
The US Food and Drug Administration (FDA) depends on healthcare professionals to pass on the details of serious adverse reactions -- but did you ever wonder what happens to the information that you submit to MedWatch? MedWatch serves as a central clearinghouse for information about drug safety. It receives voluntary reports of serious adverse events directly from consumers and healthcare professionals. If a significant risk is found to exist, ultimately, the FDA and the sponsor agree on a strategy to help manage the newly found risks. One of the most serious actions the FDA can take is to advise the pharmaceutical sponsor to remove a drug from the market. The example of liver toxicity with troglitazone (Rezulin) is a good case-study example of the valuable contribution of MedWatch reports to drug safety. Introduced for treatment of type 2 diabetes mellitus in March 1997, troglitazone was recently withdrawn from the market based on reports of serious hepatocellular injury. Ceaseless reporting of serious adverse events by healthcare professionals regardless of the labeling status played a role in the recent removal of cisapride (Propulsid) from the US market. In the future, the aging population, more new drugs, and changes in the ways drugs are used may exacerbate problems, such as misprescribing, medication errors, and unidentified drug interactions -- making the FDA's postmarketing surveillance system a more essential part of ensuring drug safety.
The US Food and Drug Administration (FDA) depends on healthcare professionals to pass on the details of serious adverse reactions -- but did you ever wonder what happens to the information that you submit to MedWatch? MedWatch serves as a central clearinghouse for information about drug safety. It receives voluntary reports of serious adverse events directly from consumers and healthcare professionals. If a significant risk is found to exist, ultimately, the FDA and the sponsor agree on a strategy to help manage the newly found risks. One of the most serious actions the FDA can take is to advise the pharmaceutical sponsor to remove a drug from the market. The example of liver toxicity with troglitazone (Rezulin) is a good case-study example of the valuable contribution of MedWatch reports to drug safety. Introduced for treatment of type 2 diabetes mellitus in March 1997, troglitazone was recently withdrawn from the market based on reports of serious hepatocellular injury. Ceaseless reporting of serious adverse events by healthcare professionals regardless of the labeling status played a role in the recent removal of cisapride (Propulsid) from the US market. In the future, the aging population, more new drugs, and changes in the ways drugs are used may exacerbate problems, such as misprescribing, medication errors, and unidentified drug interactions -- making the FDA's postmarketing surveillance system a more essential part of ensuring drug safety.
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