Warnings about cardiovascular safety-related issues associated with newly approved anticancer therapies may not be issued for up to 5 years, according to research published in JAMA Oncology. The most common reason for all evaluated black box warnings was, furthermore, cardiovascular disease-related events.

Among anticancer therapies approved by the US Food and Drug Administration (FDA), including targeted therapies and immunotherapies, cardiovascular disease events are becoming increasingly common. It was, however, previously unestablished how long it generally takes for postmarketing warnings to be issued by the FDA.

In order to better understanding this, researchers evaluated data from the Leveraging the [email protected] database and FDA drug reviews to determine the frequency of cardiovascular disease event-related postmarketing warnings in anticancer drugs approved between 1998 and 2018. Heart failure, hypertension, coronary disease, myocardial infarction, stroke, thromboembolic disease, arrhythmia, and sudden cardiac death were all included as cardiovascular disease events.

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The researchers identified 125 therapies that were approved over the evaluated period, 82 of which were biologics, targeted therapies, or immunotherapies. They also noted 411 postmarketing warnings, which included 33 black box warnings and 7 withdrawals.

Overall, 37.2% of black box warnings were related to cardiovascular disease, which was the most common reason for such warnings. Treatment classes previously associated with cardiovascular events and targeted/immune-based therapies were significantly more likely to have black box warnings (odds ratio, 1.99; P =.047).

Cardiovascular disease-related warnings also took longer to be issued (median, 1670 days) compared with other warnings (median, 1120 days; P =.03).

“Among contemporary cancer therapies, the time to postmarketing issuance of cardiovascular warnings considerably trail other safety communications,” the authors wrote. “Owing to the potentially serious consequences of cardiotoxic events, judicious enhancement of postmarketing regulation strategies is needed.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 


Bonsu JM, Kola-Kehinde O, Kim L, et al. Cardiovascular safety communications after US Food and Drug Administration approval of contemporary cancer therapies. JAMA Oncol. Published online September 30, 2021. doi:10.1001/jamaoncol.2021.4771