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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
Black box warnings were added to the label of raloxifene in 2007 warning of increased risk of death due to stroke for postmenopausal women with documented coronary heart disease or at increased risk for major coronary events, as well as increased risk for deep vein thrombosis and pulmonary embolism. [16]
Testosterone (T) is a medication and naturally occurring steroid hormone. [9] It is used to treat male hypogonadism, gender dysphoria, and certain types of breast cancer. [9] [10] It may also be used to increase athletic ability in the form of doping. [9] It is unclear if the use of testosterone for low levels due to aging is beneficial or ...
The US Food and Drug Administration has warned that antidepressants may be linked with suicidal thoughts and behaviors among youth since 2003, leading to a black box warning for minors in 2005 and ...
20 mg strength: 100-count bottles, lot Nos. RV2384 and RV2385; 1000-count bottles, lot Nos. RV2396 and RV2397.
Testosterone is the primary male sex hormone and androgen in males. [3] In humans, testosterone plays a key role in the development of male reproductive tissues such as testicles and prostate, as well as promoting secondary sexual characteristics such as increased muscle and bone mass, and the growth of body hair.
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Testosterone undecanoate is a testosterone ester and a prodrug of testosterone in the body. [10] [9] [7] Because of this, it is considered to be a natural and bioidentical form of testosterone. [17] Testosterone undecanoate was introduced in China for use by injection and in the European Union for use by mouth in the 1970s.
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