"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
No cases of overdose with AXIRON have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of AXIRON together with appropriate symptomatic and supportive care.
- AXIRON is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS].
- AXIRON is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. AXIRON may cause fetal harm when administered to a pregnant woman. AXIRON may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to AXIRON, she should be apprised of the potential hazard to the fetus. [See Use in Specific Populations].
Last reviewed on RxList: 2/6/2017
Additional Axiron Information
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