Makers of contrast agents GE and Bristol-Myers Squibb took another hit this week as the FDA is requesting a black box warning on contrast agents.
Quoted from http://www.auntminnie.com/index.asp?Sec=sup&Sub=ult&pag=dis&ItemId=77838&wf=2119:
WASHINGTON (Reuters), Oct 9 - U.S. regulators will soon alert doctors about reports of deaths and serious reactions following the use of certain imaging agents to help diagnose heart problems, Food and Drug Administration (FDA) officials said on Monday.
The contrast agents, Bristol-Myers Squibb Co's Definity and General Electric Co's Optison, are used in echocardiography. The FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were injected with either of the products, FDA spokeswoman Karen Riley said.
"The agency will soon be issuing information to healthcare professionals to alert them to these serious risks and to provide guidance regarding the safe use of this contrast agent," Riley said.
The FDA also has asked the manufacturers to update the product labels and the companies have agreed, Riley said.
The Wall Street Journal, which first reported the FDA plans, quoted unnamed sources saying the products were expected to carry a "black box" warning, the strongest type for medical products. Riley said she could not say whether the FDA had requested a black box for the information.