FDA is requiring manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).
FDA is requiring manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).
The risk of venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products, according to an FDA statement. Postmarket reports of venous blood clots unrelated to polycythemia has fueled FDA’s move to require a more general warning regarding venous blood clots, to ensure this risk is described consistently in the labeling of all approved testosterone products.
“This is another good example of how widespread use of an agent in the general population can expose unknown characteristics around a drug product,” said Robert Taketomo, PharmD, MBA, president & CEO, Ventegra.
“The FDA drug approval process is based upon the principles of safety and efficacy, not clinical effectiveness,” Dr Taketomo said.
“Fortunately, FDA and the provider community have designed processes to monitor the effectiveness of drugs once they are released into the market,” he continued. “Such processes capture the impact of overall use [eg, all types of patients, off-label indications, combinations with many other drugs, etc.] of prescription drug products such as testosterone. In rare cases, drug recalls have been initiated by FDA to remove a product from market, and address situations where clinical effectiveness data indicates a significant risk to patients that outweigh the benefits.”
Healthcare professionals and patients can report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More