Regadenoson on FDA watch for adverse effects

The FDA has added regadenoson, an adenosine myocardial perfusion agent used during cardiac stress tests, to its most recent watch list for potentially life-threatening side effects.

The drug, also known as Lexiscan, was added to the list after a potential safety issue was reported between April and June 2013. As of Aug. 1, the FDA indicated that evaluation of regadenoson’s safety would continue to determine if any regulatory action is needed.

The FDA Adverse Event Reporting System (FAERS) has indicated a potential risk of myocardial infarction and death, but the FDA notes this indication of potential risk does not necessarily mean that any instances of either have actually been reported and that a direct causal relationship between the drug and the listed risks have been identified. Usually the watch list prompts a period of drug safety surveillance.

If regadenoson is in fact proven to cause myocardial infarction, regulatory action could include labeling changes and the development of risk evaluation and reduction strategies and additional reporting efforts to improve data on the drug’s actual side effects.

Regadenoson can continue to be prescribed to patients until a clearer picture of risk is available. Patients with concerns are being prompted to contact their healthcare providers.