MATTHEW PERRONE Health Writer, Author at The Rapid City Post

FDA requires updated warning about rare heart risk with COVID shots

June 25, 2025

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update Wednesday, providing more detail about the problem and the number of people who may be affected. Pfizer and Moderna have added the information to their labels and pamphlets for patients. Myocarditis, a type of heart inflammation that is usually mild, emerged as a rare effect with the first COVID-19 shots, mainly in boys and young men. Earlier vaccine labeling advised doctors about the issue. The new warning covers a larger group.

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)

FDA to offer faster drug reviews to companies promoting ‘national priorities’

June 17, 2025

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans’ health. The new program announced Tuesday aims to review select drugs in just one to two months. It was announced by FDA Commissioner Marty Makary, who has promised “faster cures” since arriving at the agency in April. Makary says the FDA will begin offering special vouchers to drugmakers who are “aligned with U.S. national priorities.” The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict medical criteria.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Second patient death reported with gene therapy for muscular dystrophy

June 16, 2025

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. The biotech drugmaker said Sunday it was pausing shipments of the drug for patients who are no longer able to walk. The one-time treatment is the first gene therapy approved in the U.S. for the rare muscle-wasting condition. The company has faced scrutiny since its accelerated approval in 2023. Sarepta says it will pause a study of the therapy and assemble an expert panel to recommend new safety protocols for taking the drug.

This photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product labeled to contain tianeptine. (FDA Office of Regulatory Affairs, Health Fraud Branch via AP)

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

June 14, 2025

Health officials want you to think twice before buying brightly colored energy shots and supplements often sold at gas stations, convenience stores and smoke shops. The products are sometimes called “gas station heroin,” and contain tianeptine. That’s an antidepressant that can be addictive and carries the risk of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. The drug has never been approved by the FDA for any medical condition in the U.S. and cannot legally be added to foods and beverages or sold as a dietary supplement. About a dozen states have prohibited or restricted tianeptine.

MATTHEW PERRONE Health Writer.

FDA requires updated warning about rare heart risk with COVID shots

FDA to offer faster drug reviews to companies promoting ‘national priorities’

Second patient death reported with gene therapy for muscular dystrophy

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

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