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FDA removes warnings from ultrasound agent packaging 01/12/2011

In news that could have implications for pharma labels in the UK, the US Food and Drug Administration (FDA) has agreed to remove the warnings from an ultrasound agent.

Definity Injectable Suspension previously featured printed labels with written warnings about possible side-effects from its use.

However, the International Contrast Ultrasound Society began campaigning for the warnings to be removed earlier this year, insisting that they were deterring the use of a "safe, inexpensive and radiation-free diagnostic imaging tool".

Now, the FDA has agreed after reviewing safety data, which ICUS treasurer Dr Michael Main said could save lives.

"We now know that ultrasound contrast agents are extremely safe and may be an excellent low cost alternative to other diagnostic procedures," said Dr Steven Feinstein, ICUS co-president.

Ultrasound scans use sound waves and not radiation, so are generally accepted as being harmless for patients.

They can be used to monitor unborn babies, check for heart defects and find blood vessel aneurysms.

More Labelling News

Denny Bros Ltd, 01 December 2011



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