Should the FDA approve ‘sentinel’ heart drugs?

The report from the Food and Drug Administration’s (FDA) Drug Safety Advisory Committee, released in November 2017, found no evidence of elevated risks in children or cancer patients when given COVID-19. The committee made…

Should the FDA approve 'sentinel' heart drugs?

The report from the Food and Drug Administration’s (FDA) Drug Safety Advisory Committee, released in November 2017, found no evidence of elevated risks in children or cancer patients when given COVID-19.

The committee made recommendations regarding other aspects of the drug’s safety, including treatment of intussusception in some patients, but specifically noted that the experimental drug had not been tested with older adults. More specifically, in order to weigh the benefits and risks for COVID-19 and in order to make better recommendations about its potential use, the committee recommended that patients should be able to take the drug as intended at a later stage of development if all other standards were met.

The FDA now has until December 1, 2018 to review the Committee’s recommendations and will make its final determination as to whether or not COVID-19 can be given to “all appropriate patients” who are at high risk for dangerous cardiac outcomes.

According to the committee’s report, if the FDA does grant approval to COVID-19 as an alternative treatment for people with conduction tachycardia syncope (CTTCS), the drug should be used only in the subset of patients who are at a higher risk. Specifically, while high-risk patients would still be able to receive COVID-19, they would only receive the drug at higher doses. While the committee unanimously approved the idea that patients in general should not be given COVID-19 in the setting of CTTCS, there was one member of the committee, who is a cardiovascular surgery specialist, who disagreed.

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