Drugs

FDA Probing Children’s Deaths from Covid Vaccine: Makary

FDA says an evaluation of reports contained in its vaccines’ adverse event database shows there have been Covid-19 vaccine-related deaths in children and a “proper investigation” is underway that will generate a releasable report in the coming weeks. In a 9/4 appearance on The Lead with Jake Tapper on CNN, FDA commissioner Marty Makary said the agency is performing an “intense investigation. We’re talking to the primary sources, the family members who lost a child. We’re reviewing the autopsy reports. We’re having physicians do the investigation, and we think the public deserves to have that information, which was not released in the last administration.”

Asked by Tapper whether there was credible study behind HHS secretary Robert F. Kennedy Jr.’s claim that the Covid vaccine has caused serious harm, including death, especially among young people, who are more susceptible and more at risk, Makary responded: “Yes, there is because they’re at higher risk, particularly males, for myocarditis. It can be as high as one in 2,600 young males between the ages of 17 and 24. Now, that incidence may decrease with the current vaccine that’s on the market. We don't know, but that’s in the New England Journal of Medicine.

“I can tell you,” Makary continued, “when we have asked for the CDC to give us data since we came into office early on in the first few months, we got blocked, and we were given different excuses and told to wait and we can’t do it. And it was those individuals who resigned from the CDC who were in leadership who gave us the hard time about getting the data. We want to get good data so people can, as you said, make a risk-to-benefit analysis for their age group, and that is the ultimate question. We shouldn't be using dogma to say everybody should get it.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome