Federal health regulators say Merck’s experimental COVID-19 pills are effective against the virus, but external expertise on the risk of birth defects and other potential problems during pregnancy. Ask for feedback from home.
The Food and Drug Administration posted an analysis of pills prior to next week’s public meeting. There, scholars and other experts will consider its safety and effectiveness. The agency does not have to follow the group’s advice.
FDA scientists said their review identified some potential risks identified in animal pill studies, including potential toxicity to fetal development and birth defects. ..
With these risks in mind, the FDA will ask advisors next Tuesday if the drug should never be given during pregnancy or if it can be made available in certain cases.
Under that scenario, the FDA said the drug would warn about the risks during pregnancy, but doctors prescribe it in certain cases where the benefits may outweigh the risks of the patient. There are options.
Considering safety concerns, the FDA said Merck agreed that the drug would not be used by children.
Other side effects were mild and rare, with about 2% of patients experiencing diarrhea.
Regulators also noted that Merck collected far less overall safety data for the drug than it did for other COVID-19 therapies.
“The clinical safety database was small, but no major safety concerns were identified,” the FDA reviewers concluded.
In addition, the FDA has expressed concern that Merck’s drugs make small changes to the characteristic peplomer protein of the coronavirus, which it uses to penetrate human cells.
Theoretically, the FDA warned that these changes could lead to dangerous new variants.
The FDA asks an independent advisor to discuss all these issues and vote on whether the overall benefits of the drug outweigh the risks.
All COVID-19 drugs currently approved by the FDA require injection or IV and can only be administered by a healthcare professional. If approved, Merck’s medication will be the first US patient to take home to relieve symptoms and speed recovery.Emergency use is already permitted in the UK
The conference is the first public review of a new COVID-19 drug by regulators and reflects strong interest and scrutiny of tablets that millions of Americans may soon use. increase.
Merck COVID pills are effective and experts confirm their safety
Source link Merck COVID pills are effective and experts confirm their safety