According to the Wall Street Journal, the FDA will be asking Bristol-Myers Squibb Co.(NYSE:BMY) to add a "black box" warning to its ultrasound contrasting agent, Definity. The FDA has concerns that it can trigger dangerous cardiopulmonary reactions in some patients.
The warning will advise that the Definity not be used on patients that suffer from conditions such as unstable angina, unstable cardiopulmonary disease or who have suffered acute heart attacks.
A Bristol-Myers spokesman confirmed that the company was discussing updating the safety instruction with the FDA.
Definity was approved for use by the FDA in July 2001. It is a special dye that is used during some echocardiograms to help doctors see a clearer image of a patient's heart. The approval in 2001 came with warnings that patients with a heart shunt, have severe emphysema or inflammation of the blood vessels in the lungs should not be exposed to Definity.
[Source: MarketWatch]
» Bristol Myers Squibb from PharmaGazette
Bristol-Myers Squibb (NYSE:BMY), #12 in sales in 2006 and #13 in R&D in 2006 with $2.32 bn EUR budget still hasn’t managed to pull out of the mess of the last few years. While it has a few strategic partnerships with... [Read More]
Tracked on: December 14, 2007 10:34 AM | Permalink to Trackback