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FDA raises warnings for imaging drugs

The FDA receives reports of heart problems and deaths in patients treated with cardiac imaging agents

The FDA has received reports of heart problems and deaths in patients treated with cardiac imaging agents.

The agency is specifically targeting Bristol-Myers Squibb's (BMS) Definity and General Electric's (GE) Optison, according to spokesperson Karen Riley. Both companies have been told to add information about the risks to drug labelling.

The drugs in question are used to improve the resolution of medical images of the heart. The FDA now plans to alert doctors to the problems over the week and offer new guidance on using the drugs safely.

A BMS spokesperson confirmed that the company was discussing labelling changes with regulators. Since Definity was approved in 2001, BMS says the agent has been used in two million people and racked up sales of USD 65m in FY06. Optison was approved in 1997, but GE temporarily suspended the drug from the market in 2005.

Both drugs are used in echocardiograms, an ultrasound procedure that shows movement of blood through the heart. The agents contain tiny gas bubbles which aid in the identification of small clots and other potential problems.

BMS' shares fell USD 0.14 on 9 October 2007 to rest at USD 29.95 in morning trading. GE's shares fell USD 0.15 to USD 41.62.

Acusphere reacts quickly
Acusphere, a US-based specialty pharmaceutical company, felt compelled to release a press statement regarding its lead product candidate, Imagify (perflubutane polymer microspheres), after its shares dropped USD 0.31, or 18.7 per cent, to rest at USD 1.35, as the market reacted to the FDA concerns.

Acusphere is preparing to submit Imagify to the FDA later in 2007. The company said in a statement there have been no reported deaths in more than 1,000 patients tested with the drug. The company currently has no products on the market.

In aftermarket trading, Acusphere shares recovered USD 0.07, or 5.2 per cent, to reach USD 1.42 on 9 October after the company stressed its experimental imaging agent was structurally different from BMS' and GE's products.

"We remain convinced that Imagify is poised to address a potential multi-billion dollar market in the US alone," the company declared.

30th September 2008

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