New cancer warning for tamoxifen users

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New cancer warning for tamoxifen users

Last Updated: 2002-06-28 12:08:45 -0400 (Reuters Health)

WASHINGTON (Reuters Health) - 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.