US FDA flags concerns over COVID pills' side effects on pregnancytext_fields
Experimental Covid-19 pill by Pharmaceutical Company Merck & Co. has been declared effective by US federal health regulators. But, the risk of birth defects and other problems during pregnancy still hasn't been ruled out.
If the drug is approved, this will be the first treatment for Covid-19 that patients can take home. So far, all the Covid-19 drugs approved by the FDA are injected or delivered through an IV.
Merck has used a new approach by inserting tiny mutations into the coronavirus' genetic code to make it infertile. This has led to concerns that the drug may cause birth defects or tumours. The company excluded pregnant women from their data collection. Other participants were asked to abstain from sex or use contraception.
The FDA posted its analysis of the new drug and said that their review has identified possible toxicity and birth defects. The pill carries warnings about risks during pregnancy but doctors will still have the option to prescribe it if the benefits could outweigh the risks. Merck has also agreed that the drug will not be used in children, reported The Guardian.
FDA flagged the concern that the pill has led to changes in the spike protein of coronavirus. In theory, such a change in the virus can lead to dangerous variants. The spike protein is a signature characteristic of the coronavirus as it is used to penetrate the human cells. US officials observed that Merck has collected less data regarding the safety of its product than other Covid-19 therapies.
Experts will weigh in next week in a public meeting. FDA will seek the opinion of independent advisers to discuss all the issues in question and vote on them. It will be the first time US regulators have publicly reviewed a new drug for Covid-19.