ADR that result in revision of patient information
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| The United States: FDA adding general warning to testosterone products about potential for venous blood clots |
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The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. As there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.
Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.
Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm
In Hong Kong, there are eight registered pharmaceutical products containing testosterone which are prescription-only medicines. The FDA and EMA started investigating the risk of cardiovascular events of testosterone products and the related news was posted on the Drug Office website on 4 February 2014 and 12 April 2014 respectively. So far, the Department of Health has not received any adverse drug reaction report on venous thromboembolism associated with the use of the drug. In view of the announcement by the FDA, a letter to healthcare professionals will be issued to draw their attention on the matter, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board for consideration of updating the warning on the product label and/or package insert of the products containing testosterone.
Ends/ Friday, June 20, 2014
Issued at HKT 14:00
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