Describe in detail reason why vioxx was withdrawn

Reference no: EM133514818

Problem

Drug safety is one of the hottest topics in daily medical practice, particularly with regard to approving new medication or questioning the possibility of withdrawing a drug from the market. The aim of this review is to highlight the importance of the drug safety concept and its impact on patients' health.

Up until now, there are drugs that could be taken off the market or withdrawn due to safety issues concerning their relationship with the emergence of serious side effects, such as the recent withdrawal of the anti-diabetic agent rosiglitazone (Avandia®) from the global market as a result of its relationship with the incidence of heart attacks. Similarly, Vioxx (rofecoxib) was a drug used to treat arthritis, acute pain and menstrual cramps. It was withdrawn from the market by its maker, Merck, in 2004 because of safety concerns of an increased risk of cardiovascular events (such as heart attack and stroke) in patients taking Vioxx.

Therefore, we find the concept of drug safety a very important and comprehensive concept that is considered a priority with regard to the use of medications. Actually, this concept can be considered an integrated science in itself that involves many other scientific aspects, such as the side effects of drugs, the quality of medications, medical errors in the use of drugs, lack of efficacy of drugs, and counterfeit drugs.

Task

Question A. Describe in detail with thorough explanation that causes the failure of Avandia® using drug safety background.

Question B. Describe in detail reason why Vioxx was withdrawn from the market? What are the baseline justifications that made FDA to issue withdrawal letter to Merck?

Reference no: EM133514818

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