Nieuwe waarschuwing tegen tamoxifen.*

Voor Tamoxifen, een medicijn dat wordt gebruikt ter preventie van en bestrijden van borstkanker wordt weer gewaarschuwd. De waarschuwingen door de FDA (Food and Drug Administration) betreffen het kunnen optreden van baarmoederkanker, hartaanvallen en potentieel fatale bloedklonteringen in de longen. Artsen dienen samen met hun patiŽnten de voor- en nadelen goed te bekijken. Eerder al werd gewaarschuwd Tamoxifen niet langer dan 2 jaar te blijven gebruiken.

- A new warning has been added to the label of the cancer drug Novaldex (tamoxifen citrate), noting that the drug has been linked to a certain type of uterine cancer, as well as strokes and potentially fatal blood clots in the lung, according to documents released by the US Food and Drug Administration (FDA) on Thursday. The documents included a "Dear Doctor" letter, the revised label and the new patient insert, all of which were dated mid-May. According to the letter, the warning was developed to urge physicians to be cautions about using the drug, which can both treat and prevent breast cancer. The FDA notes that while the drug has already been linked to endometrial cancer, or cancer of the uterine lining, there is new data suggesting it also boosts the risk of a rare but more aggressive type of uterine cancer called a sarcoma. "These data, and the previously reported increased risk of stroke and pulmonary embolism, have prompted changes to the Nolvadex label," the letter states. The new label states that the benefits of tamoxifen outweigh its risks in women who already have breast cancer, but that doctors "should discuss the potential benefits versus the potential risks of...serious events" with patients receiving or considering Nolvadex to reduce the risk of developing breast cancer. The company stressed in its letter that it believes there are "clear benefits" of Nolvadex for breast cancer risk reduction, but that risk-benefit calculations must be made on an individual basis. (juni 2002)

 

 

 

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