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Keyword: cellcept

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  • FDA stresses birth defect risks with Roche drug (CellCept)

    05/17/2008 7:57:51 AM PDT · by neverdem · 2 replies · 132+ views
    San Luis Obispo Tribune ^ | May. 16, 2008 | MATTHEW PERRONE
    AP Business Writer Health regulators warned again Friday that Roche and Novartis drugs prescribed to organ transplant patients can cause miscarriages and birth defects when used by pregnant women. The Food and Drug Administration last October said it received reports of miscarriages and infants born with ear and mouth birth defects after their mothers took Roche's CellCept. At the time, FDA added its most serious warning to CellCept and a similar Novartis AG drug, Myfortic. FDA spokesman Christopher Kelly said the agency has not received any new reports of pregnancy-related problems, but was concerned some doctors may not have seen...
  • FDA investigates transplant drugs' risks

    04/10/2008 4:31:29 PM PDT · by neverdem · 2 replies · 40+ views
    San Luis Obispo Tribune ^ | Apr. 10, 2008 | MATTHEW PERRONE
    AP Business Writer Regulators are exploring whether organ transplant drugs made by Roche and Novartis increase the risk of an often-fatal neurological disease. The Food and Drug Administration said Thursday it has identified 16 cases of patients developing the rare neurological ailment while taking Roche's drug CellCept, which is used to avoid rejection in organ transplant patients. U.S. regulators approved CellCept in 1995. The Swiss drug maker Roche alerted regulators to the issue last November. FDA said it is looking into similar risks with Myfortic, a drug made by fellow Swiss drugmaker Novartis that includes the same key ingredient as...