IGMPI India



Astella receives FDA warning for its stress test drug

According to new warning issued by the US Food and Drug Administration two drugs that are used as intravenously during cardiac nuclear stress tests, namely Lexiscan (regadenoson) and Adenoscan (adenosine) are reported to be linked with side effects that are rare but serious. These side effects can possibly result into heart attack and even death.
The said drugs are used for dilatation of arteries of the heart during the stress test procedure. These drugs help in determining the exact location of blockages or arterial obstructions. But recent reports have noted serious adverse events related to these drugs like unstable angina or cardiovascular instability. This has led the FDA to approve changes in the drug labels and mention the updated recommendations for their appropriate use.

FDA has therefore issued a warning as precautionary measures that need to be taken while performing the stress test. This could mean having a provision of cardiac resuscitation equipment at hand in case it is required along with a trained staff for its use. According to the FDA such warnings would be included in the drug labels.