Wednesday, January 19, 2022

FDA: Merck’s COVID pills are effective, experts will review safety

Federal health authorities say Merck’s experimental COVID-19 pill is effective against the virus, but they will seek outside expert opinion on the risks of birth defects and other potential problems during pregnancy.

The FDA has released its analysis of the tablet ahead of a public meeting next week where scientists and other experts will discuss its safety and effectiveness. The agency is not required to follow the advice of the group.

The FDA scientists said their review highlighted several potential risks, including possible toxicity to developing fetuses and birth defects that were found in animal studies of the tablets.

Given these risks, the FDA will ask its consultants next Tuesday if the drug should never be given during pregnancy or if it can be made available in certain cases.

Under this scenario, the FDA said the drug would contain warnings about risks during pregnancy, but doctors would still be able to prescribe it in certain situations where its benefits might outweigh the risks to patients.

The FDA said that given the safety concerns, Merck agreed that the drug will not be used in children.

Other side effects were mild and rare, with about 2% of patients experiencing diarrhea.

Regulators also noted that Merck has collected far less overall safety data for its drug than has been collected for other COVID-19 treatments.

“Although the clinical safety database was small, no major safety issues were identified,” concluded the FDA reviewers.

In addition, the FDA has expressed concern that the Merck drug has led to small changes in the signature protein of the coronavirus, which it uses to enter human cells.

In theory, the FDA warns, these changes could lead to new dangerous options.

The FDA will ask its independent consultants to discuss all of these issues and then vote on whether the overall benefits of the drug outweigh its risks.

All COVID-19 drugs currently approved by the FDA require injection or intravenous administration and can only be administered by healthcare professionals. If permitted, Merck will be the first drug that US patients can take at home to relieve symptoms and speed up recovery. It is already licensed for emergency use in the UK.

The meeting marks the first time that a new drug for COVID-19 has been publicly reviewed by regulators, signaling close attention and attention to a pill that could soon be used by millions of Americans.

Nation World News Deskhttps://nationworldnews.com
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