Vioxx Returning To The Market Tips
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How has Merck responded to charges of coverup in the case of Vioxx?
Merck Vice President Dennis Erb has defended the company's handling of Vioxx, noting that it promptly released details of studies that first raised the possibility of heart damage and followed up by performing the study that ultimately doomed the drug. "We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option," he said. "My own father was a regular user of Vioxx until we voluntarily withdrew it from the market."
Will Vioxx be coming back on the market?
Despite a barrage of negative press and criticism, Merck is considering returning Vioxx to the market but has reached no decision, Erb said. The company has asked the FDA to spell out what additional information would be needed to bring Vioxx back. An important hearing on Vioxx held in May of 2005 by the Senate Finance Committee may prove to be a milestone in congressional efforts to strengthen the FDA's drug safety program. Until now, some members of the Senate have focused on the subject, but the House has remained on the sidelines. After the hearing, panel Chairman Thomas M. Davis (R-Va.) said that legislation might be needed.
Under what circumstances might Vioxx return to the market?
In spite of the shakeup at Merck over the dangerous side effects of Vioxx--including the recent resignation of their CEO--there is talk of bringing Vioxx back on the marketplace. Because many people say Vioxx offered relief that other drugs didn't, the FDA's scientific advisers in February of 2005 narrowly voted that Vioxx might be able to come back onto the market under certain conditions, such as restricting its use to patients with severe pain or loading it with strong warnings about the heart risk.
Is Merck considering bringing Vioxx back to the market?
Merck Vice President Dennis Erb has recently indicated that in spite of the debacle over the safety of Vioxx, the company is interested in making Vioxx available to consumers again. "We're now in preliminary discussions (with the FDA) to see what information they would need to review for putting Vioxx back on the market," Erb said recently.
