FDA investigating link between Vytorin and cancer.
The Wall Street Journal (8/22, B7, Favole, Mundy) reports that the Food and Drug Administration (FDA) "is reviewing a recent study, called SEAS, that found an increased risk of cancer and deaths from cancer in patients taking Vytorin (ezetimibe and simvastatin), compared with those given a placebo." The agency "expects to receive a final SEAS study report from the Merck/Schering-Plough joint venture in about three months and said it will likely take...six months to fully evaluate the data."
Investigators "involved in the SEAS study said during a July 21 press conference to discuss the data that the increased cases were likely due to chance,"
Bloomberg (8/22, Larkin, Pettypiece) adds. In order "to see if there was a risk, Richard Peto, professor of medical statistics and epidemiology at the University of Oxford, analyzed larger and longer studies of Vytorin that would be more likely to find one." But he "found no increase in cancers in those studies and concluded the SEAS finding was likely an anomaly."
The FDA "said patients should not stop taking Vytorin because the evidence of a cancer link is unclear," according to the AP (8/22, Alonso-Zaldivar, Johnson). The agency said that "while one recent clinical trial indicated higher rates of cancer for patients taking the medication, two studies currently under way have shown no increased risk." Meanwhile, "leaders of the powerful House Energy and Commerce Committee asked the companies for extensive data on the" SEAS trial. Rep. John D. Dingell (D-Mich.), who chairs the committee, "and Rep. Bart Stupak (D-Mich.), chairman of its Oversight and Investigations subcommittee, sent a letter to the chief executives of the drug companies, giving them two weeks to supply detailed information." The lawmakers "are investigating drug industry safety issues and marketing practices, and have been focusing increasingly on Vytorin." MedPage Today (8/21, Peck) and
WebMD (8/21, DeNoon) also covered the story.
The Wall Street Journal (8/22, B7, Favole, Mundy) reports that the Food and Drug Administration (FDA) "is reviewing a recent study, called SEAS, that found an increased risk of cancer and deaths from cancer in patients taking Vytorin (ezetimibe and simvastatin), compared with those given a placebo." The agency "expects to receive a final SEAS study report from the Merck/Schering-Plough joint venture in about three months and said it will likely take...six months to fully evaluate the data."
Investigators "involved in the SEAS study said during a July 21 press conference to discuss the data that the increased cases were likely due to chance,"
Bloomberg (8/22, Larkin, Pettypiece) adds. In order "to see if there was a risk, Richard Peto, professor of medical statistics and epidemiology at the University of Oxford, analyzed larger and longer studies of Vytorin that would be more likely to find one." But he "found no increase in cancers in those studies and concluded the SEAS finding was likely an anomaly."
The FDA "said patients should not stop taking Vytorin because the evidence of a cancer link is unclear," according to the AP (8/22, Alonso-Zaldivar, Johnson). The agency said that "while one recent clinical trial indicated higher rates of cancer for patients taking the medication, two studies currently under way have shown no increased risk." Meanwhile, "leaders of the powerful House Energy and Commerce Committee asked the companies for extensive data on the" SEAS trial. Rep. John D. Dingell (D-Mich.), who chairs the committee, "and Rep. Bart Stupak (D-Mich.), chairman of its Oversight and Investigations subcommittee, sent a letter to the chief executives of the drug companies, giving them two weeks to supply detailed information." The lawmakers "are investigating drug industry safety issues and marketing practices, and have been focusing increasingly on Vytorin." MedPage Today (8/21, Peck) and
WebMD (8/21, DeNoon) also covered the story.
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