FDA Issues Recall Notice About Cardiovascular Systems’ Diamondback 360 Blood Vessel Tool

The FDA recently warned healthcare professionals of a recall of Diamondback 360 Peripheral Orbital Atherectomy Systems. This medical device is inserted into patients' blood vessels and used "to reestablish blood flow in narrowed arteries." Cardiovascular Systems has recalled certain lot [...]

By |2019-05-24T07:36:29+00:00September 9th, 2014|Blog Posts in 2014, News Blog|0 Comments

FDA Requires Manufacturers To Put A General Warning About Venous Blood Clots Risks With Testosterone Products

On 6/19/2014, the FDA issued a drug safety statement affecting all FDA-approved testosterone products currently on the market. According to the statement: "[FDA] is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products [...]

By |2019-05-24T07:42:39+00:00June 30th, 2014|Blog Posts in 2014, News Blog|0 Comments

Corticosteroid Injections Could Lead To Serious Neurologic Problems

The FDA recently issued a safety warning about serious adverse effects associated with spinal injections of corticosteroids. Injectable corticosteroids are drugs that are often used to reduce swelling or inflammation. These include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. Spinal injections [...]

By |2019-05-24T07:40:47+00:00May 9th, 2014|Blog Posts in 2014, News Blog|0 Comments

The European Medicines Agency Initiates Review Of Testosterone Products Over Concerns About Cardiac Side Effects

The European Medicines Agency (EMA) recently started a safety review of testosterone-containing products. The review was initiated at the request of the Estonian medicines agency due to concerns about harmful effects of testosterone therapy (TT) on the heart. These safety [...]

By |2019-05-24T07:46:38+00:00April 14th, 2014|Blog Posts in 2014, News Blog|0 Comments

Testosterone Study Observed Discrepancy In Risk Reported By Industry Funded Trials Compared To Non-Industry Funded Trials

A recent study published in 2013 warned that the risk of cardiovascular events is increased in men who have been prescribed testosterone therapy. Such cardiovascular events included heart attacks, congestive heart failures, coronary artery diseases, arrhythmias, and other cardiovascular disorders. [...]

By |2019-05-24T07:50:05+00:00February 3rd, 2014|Blog Posts in 2014, News Blog|0 Comments