FDA Warnings Added to Bristol-Myers/GE Heart Drugs
Drugs manufactured by both General Electric and Bristol-Myers Squibb, employed to generate clearer images of human hearts, will now be issued with warnings after the US Food and Drug Administration discovered they could induce potentially lethal side effects.
The drugs in questions are Definity – manufactured by Bristol Myers - and Optison – from General Electric. As per US FDA spokeswoman Karen Riley, the regulator has been provided with reports that both have caused cardiovascular complications and, in some instances – death. Consequently, the FDA has ordered the two firms to modify the drugs’ labels in order that their risks be highlighted.
In the next few days, the FDA will ensure physicians are aware of the situation concerning Definity and Optison, additionally providing guidance on how the drugs can be used in a safe way.
Jeff Macdonald, a spokesman from Bristol Myers, provided confirmation that the firm is engaged in conversation with the regulator, and that the topic was label modification, but did not elaborate on this.
Having been approved six years ago, Definity, according to its manufacturers, has been used by around two million patients. In 2006, sales of the drug totalled $65 million.
Optison received approval ten years ago. However, in 2005, General Electric withdrew it from the market when an FDA assessment of Mallinckrodt, an associated manufacturer, threw up queries regarding Optison’s sterility. This year, GE confirmed the issue had been resolved, and that Optison would be re-launched this month.
Again, a spokesman from the group, Brian McKaig, confirmed discussions were ongoing with the FDA in respect of Optison’s labelling being revised. To date, approximately one million patients have taken the drug, with only a very small minority reporting side effects, added Mr McKaig.
Both Optison and Definity are employed in echocardiograms, a procedure involving ultrasound that highlights how blood is flowing through the heart. Minute gas bubbles are contained within the agents, assisting doctors in identifying small clots and other forms of heart-related abnormalities.
Source – Pharmaceutical International’s US Correspondent
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