Here is a little something for fans of Nolvadex for fat-loss. This is straight from the newly revised (5/2002) patient insert. I'll try and get permission to post the letter sent out to doctors.
You may wish to argue that the study only involved women with existing breast cancer or high-risk patients. But I wouldn't want to push it until all the data are in, which may take quite a while for off-label uses.
Nolvadex patient insert black box warning!
----------------------------------------snip --------------------------------------
NDA 17-970/S-049
Page 3
Rev 05-02
SIC XXXXX-XX
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast
Cancer: Serious and life-threatening events associated with NOLVADEX in the risk reduction setting
(women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and
pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see
CLINICAL PHARMACOLOGY-Clinical Studies – Reduction in Breast Cancer Incidence In High Risk
Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000
women-years of 2.20 for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000
women-years of 0.17 for NOLVADEX vs 0.0 for placebo)*. For stroke, the incidence rate per 1,000
women-years was 1.43 for NOLVADEX vs 1.00 for placebo**. For pulmonary embolism, the incidence
rate per 1,000 women-years was 0.75 for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.
Health care providers should discuss the potential benefits versus the potential risks of these serious events
with women at high risk of breast cancer and women with DCIS considering NOLVADEX to reduce their
risk of developing breast cancer.
The benefits of NOLVADEX outweigh its risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See
WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical Studies.
DESCRIPTION
NOLVADEX ® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration.
NOLVADEX Tablets are available as:
10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of
tamoxifen.
20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of
tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch.
--------------------------------------------------snip------------------------------------------------------------------
You may wish to argue that the study only involved women with existing breast cancer or high-risk patients. But I wouldn't want to push it until all the data are in, which may take quite a while for off-label uses.
Nolvadex patient insert black box warning!
----------------------------------------snip --------------------------------------
NDA 17-970/S-049
Page 3
Rev 05-02
SIC XXXXX-XX
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast
Cancer: Serious and life-threatening events associated with NOLVADEX in the risk reduction setting
(women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and
pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see
CLINICAL PHARMACOLOGY-Clinical Studies – Reduction in Breast Cancer Incidence In High Risk
Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000
women-years of 2.20 for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000
women-years of 0.17 for NOLVADEX vs 0.0 for placebo)*. For stroke, the incidence rate per 1,000
women-years was 1.43 for NOLVADEX vs 1.00 for placebo**. For pulmonary embolism, the incidence
rate per 1,000 women-years was 0.75 for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.
Health care providers should discuss the potential benefits versus the potential risks of these serious events
with women at high risk of breast cancer and women with DCIS considering NOLVADEX to reduce their
risk of developing breast cancer.
The benefits of NOLVADEX outweigh its risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See
WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical Studies.
DESCRIPTION
NOLVADEX ® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration.
NOLVADEX Tablets are available as:
10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of
tamoxifen.
20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of
tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch.
--------------------------------------------------snip------------------------------------------------------------------