Jane S. Ricciuti, RPh, MS


October 23, 2002

In This Article

Nonsteroidal Antiestrogens

(tamoxifen) Tablets

Manufacturer: AstraZeneca Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 8/30/02)

Clinical Summary: This supplemental new drug application provides for the labeling to include the results of tamoxifen 20-mg tablets studied in girls with McCune-Albright syndrome. Twenty-eight female patients, aged 2 to 10 years, were treated for up to 12 months. There was a 50% reduction in the frequency of vaginal bleeding episodes. The linear growth rate was reduced during tamoxifen therapy in the majority of patients. Long-term effects beyond 12 months and use below 2 years of age have not been studied

In adult patients treated with tamoxifen, there is an increased incidence of endometrial adenocarcinoma and uterine sarcoma. It is recommended that patients treated with tamoxifen be monitored for long-term uterine effects.

Nolvadex (tamoxifen) labeling.

Nolvadex (tamoxifen)


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