US FDA officials to seek advice from experts on safety of Merck's COVID treating pill

The United States' federal health officials asserted that Merck's experimental COVID treating pill is effective against the virus, but they will seek advice from other specialists on the dangers of birth abnormalities and other potential complications during pregnancy.

The US Food and Drug Administration (FDA) published its review of the pill ahead of a public hearing next week in which academic and other experts will weigh in on the medicine's safety and effectiveness. However, the agency is not compelled to heed the group's recommendations, AP reported. The conference will be the first time authorities will publicly assess Molnupiravir, a new COVID pill that could soon be used by millions of Americans, according to AP.

Merk's COVID treating pill reduced hospitalisations and fatalities

Molnupiravir, the medication, has been found to drastically reduce hospitalisations and fatalities in persons with mild-to-moderate coronavirus infections. Merck's medication combats COVID-19 using a unique approach: it introduces microscopic changes into the coronavirus' genetic coding to prevent the virus from multiplying. However, this genetic influence has sparked fears that the treatment could induce birth abnormalities or even spur more aggressive versions of the virus in rare situations.

According to the FDA scientists, their examination uncovered multiple potential hazards, including probable harm to developing foetuses and birth abnormalities discovered in animal studies of the tablet. Because of the safety concerns, the FDA stated that Merck agreed the medicine would not be used in youngsters. Other adverse effects were modest and uncommon, with approximately 2% of individuals having diarrhoea. Regulators also noticed that Merck acquired significantly less overall safety data on its medicine than other COVID-19 medications.

"While the clinical safety data base was small, there were no major safety concerns identified," FDA reviewers said, AP reported.

FDA to confer with experts about the effects of Merk's COVID pill

Given these dangers, the FDA will consult with its experts next Tuesday to determine whether the medicine should be avoided during pregnancy or made available in limited circumstances. Under that scenario, the FDA stated that the treatment would have warnings about pregnancy risks, but doctors would still be able to prescribe it in cases where the benefits outweighed the risks for patients. The FDA will request that its independent advisers discuss all of these problems before voting on whether the drug's overall benefits outweigh its hazards.

All COVID-19 medications currently approved by the FDA need an injection or IV and can only be administered by trained medical personnel. If approved, Merck's medicine would be the first that patients in the United States may take at home to relieve symptoms and expedite recovery. It is already authorised for deployment in an emergency in the UK.

(With inputs from agencies, Image: AP)