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Posicor Inc Case Study

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Early in June 1998, Roche Laboratories of Nutley, NJ, abruptly and voluntarily withdrew its novel T-channel blocker, Posicor (mibefradil), from the market. The drug, used to treat hypertension, was just a few days short of celebrating its first year of release. The withdrawal came after reports of dangerous and even fatal interactions with at least 25 other drugs, including common antihistamines, and cancer drugs. Posicor, which went onto the general market in August 1997 after its final approve in June of the same year, was being taken by almost 200 000 Americans and nearly double that number worldwide for both hypertension and angina. Its withdrawal was a logistical nightmare for many large cardiology practices faced with the need to notify patients that they would need to obtain a different prescription (AHA, 1998). Bayer Pharmaceutical Division has announced its decision to withdraw Baycol (cerivastatin) from the U.S market following reports of rhabdomyolysis, a severe muscle adverse reaction than can sometimes have fatal consequences. The FDA has agreed with and supported this decision (WHO, 2001) …show more content…

announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children (US FDA,

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