Cholesterol

FDA requests removal of strongest warning against statin use among pregnant women

13 days ago   |   By Healio

The FDA requested removal of its contraindication against using cholesterol-lowering statin medicines among pregnant patients; however, most patients should stop statins once they learn they are pregnant.
A contraindication is the FDA's strongest warning and only added when a medicine should not be used due to risk that outweighs any possible benefit.
According to an FDA press release, statins may prevent major adverse events among certain high-risk patients who are pregnant; therefore, contraindicating statin therapy for all pregnant women is not appropriate.
The FDA added that patients
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Changed Warning on Statins; Novel Anticoagulant Shines; Porous Clots in Stroke

Changed Warning on Statins; Novel Anticoagulant Shines; Porous Clots in Stroke

13 days ago   |   By MedPageToday

FDA is walking back the contraindication against statins for pregnant patients, but the agency maintains that most pregnant people should stop statin therapy.
Rates of venous thromboembolism after elective total knee arthroplasty...
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FDA to Cut Broadly Worded Statin Pregnancy Contraindication

FDA to Cut Broadly Worded Statin Pregnancy Contraindication

13 days ago   |   By Medscape

The changes emphasize that 'statins are safe to prescribe in patients who can become pregnant' and reassure women that harm is unlikely from unintended statin exposure in early pregnancy.
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Cholangiopathy after severe COVID-19 may lead to liver injury, failure

Cholangiopathy after severe COVID-19 may lead to liver injury, failure

For patients with severe COVID-19, cholangiopathy was a late complication with potential for progressive biliary injury or liver failure, according to a study published in the... Read more ...

Mississippi woman pleads others to get vaccinated as her husband is hospitalized

Mississippi woman pleads others to get vaccinated as her husband is hospitalized

William Thomas Ball, 51, has been hospitalized with COVID-19 in Jackson, Mississippi after refusing to get vaccinated. Now his wife, Alicia, is asking for others in her... Read more ...

Covid England: Cases are now falling in ALL age groups, official data reveals

Covid England: Cases are now falling in ALL age groups, official data reveals

EXCLUSIVE: Covid cases are falling in all age groups, and dropping fastest among adults in their twenties according to data from the Department of Health. Read more ...

Lumbar artificial disc yielded positive 7-year outcomes for degenerative...

Lumbar artificial disc yielded positive 7-year outcomes for degenerative disc disease

For total disc replacement in patients with degenerative disc disease, an artificial disc is a safe option that improves pain relief, function, range of motion and decreases in... Read more ...

FDA clamps down on imported shark fins, cantaloupes, mushrooms and more

FDA clamps down on imported shark fins, cantaloupes, mushrooms and more

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as... Read more ...

FDA TechTalk podcast episode to focus on whole genome sequencing

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Nowadays, it seems rare to find someone or some entity without a podcast, and the Food and Drug Administration is no exception. The TechTalk podcast is hosted by the FDA and... Read more ...

COVID Breakthrough Cases Ran the Gamut in Healthcare Workers

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Breakthrough COVID-19 cases in fully vaccinated healthcare workers were rare, and generally were associated with the individual's immune response to the vaccine in the early... Read more ...

Some IBD Treatments in Pregnancy Had No Effect on Kids' Infection Risk

Some IBD Treatments in Pregnancy Had No Effect on Kids' Infection Risk

Exposure to immunosuppressive monotherapies in utero did not increase serious infection risks in young children born to mothers with inflammatory bowel disease , but the same... Read more ...

FDA issues complete response letter for retifanlimab for anal cancer

FDA issues complete response letter for retifanlimab for anal cancer

The FDA issued a complete response letter to Incyte indicating it cannot approve the company's biologics license application that seeks approval of retifanlimab for certain... Read more ...

Bristol Myers Squibb withdraws liver cancer indication for nivolumab

Bristol Myers Squibb withdraws liver cancer indication for nivolumab

Bristol Myers Squibb in consultation with the FDA voluntarily withdrew the indication for nivolumab as monotherapy for patients with hepatocellular carcinoma previously treated... Read more ...