Posicor May Have Caused Over 100 Deaths
May 15, 2001
Even faced with the knowledge that a new drug used to fight high blood pressure could cause serious heart arrhythmias and even death, the FDA chose to approve Hoffman-La Roche Inc.'s Posicor. According to FDA officials, during clinical trials of Posicor a 70-year-old man died suddenly after taking the drug. Posicor "cast a shadow of potential risk for serious arrhythmias," said FDA official Dr. Shaw T. Chen in 1996. There was also great concern among FDA researchers that Posicor could interact dangerously with other drugs.
Along with the 70-year-old victim who died after taking Posicor, the FDA had evidence that over 140 other participants in a Posicor trial may have died after taking the drug. Unfortunately, Hoffman-La Roche Inc.'s study was held in strict confidence by the company, so FDA officials were not able to confirm the reports. The official results of the study would not be released for at least one year. The FDA was forced to choose between delaying Posicor's approval for up to a year or simply approve the drug and hope for the best. "I sure don't feel good about what I've seen," said Dr. Lemuel A. Moye, an FDA investigator. "I'm afraid that we are racing into this." Dr. Moye was also concerned about deadly drug interactions, the results of which were unknown. "Patients will be taking this in fairly uncontrolled situations in combinations of drugs which have ramifications yet unknown," he said.
Other FDA officials, such as Dr. Robert Califf, questioned the need to approve yet another blood pressure medication when there were already several effective treatments available on the market. "If this [drug] was really something that was dramatically different, better than anything else in the way of relieving symptoms, then I would look at it differently. But given the fact there are a lot of other effective therapies out there, why not be safe with the public?" Posicor's manufacturer dismissed the drug's tendency to cause deadly heart arrhythmias. The company did a good job convincing others at the FDA that Posicor was indeed safe, and the FDA voted to approve Posicor in June 1997.
As with other drugs recently approved by the FDA and subsequently removed from the market, Posicor's label or "package insert" made little mention of the drug's dangerous side effects. In tiny type, buried deep inside the prescription information that doctors rarely have time to read, the company revealed that Posicor could be life threatening if used in combination with certain other medications. Dangerous interactions were said to occur when Posicor was taken in conjunction with allergy pills, tranquilizers, a sleeping pill and the recently recalled heartburn drug Propulsid.
Despite the U.S. approval of Posicor, some countries, such as Sweden, determined that the drug was simply too dangerous. However, the economic pressure placed upon investigators to approve the drug in the U.S. was too great. One securities analyst predicted that Posicor would bring in almost $3 billion to Hoffman - La Roche.
Approximately six months after Posicor's June 1997 FDA approval, the agency began to receive a troubling number of reports of heart problems and extremely low blood pressures in those taking the drug. These reports lead the FDA to increase the number of drugs listed as dangerous if taken simultaneously with Posicor to 26. Approximately six months later Posicor was pulled from the market after reports of deaths associated with the drug began to increase. In fact, the numbers indicated that patients taking Posicor were 10% more likely to die than those taking a related medication. Posicor's manufacturer admitted that the drug did not appear to help patients at all. Subsequent reports indicated that Posicor could be responsible for well over 100 deaths.
According to Dr. Moye of the FDA, "Posicor should not have been approved. Therefore, any death that was attributable to Posicor was an unnecessary death." Dr. Moye's superiors at the agency apparently disagreed with him when they approved the drug. In hindsight, Moye was certainly correct in his assessment of Posicor.
-- Article Courtesy of InjuryBoard.com
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