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FDA approves use of Molnupiravir for treatment of coronavirus infection, but with serious restrictions

The Food and Drug Administration (FDA) has authorized doctors to use Molnupiravir, an oral coronavirus drug (tablet) developed by Merk in partnership with Ridgeback Biotherapeutics. The authorization concerns the treatment of mild to moderate coronavirus infection (COVID-19) in adults at high risk of progression to severe disease, including hospitalization or death. The issued permit contains a number of serious restrictions, including an almost complete ban on the use of the drug by pregnant women and persons wishing to conceive a child.

The drug should only be used if FDA-cleared alternatives have not worked, and if they are not available or clinically unsuitable. Taking the medicine is possible only as directed by a doctor within five days from the moment the symptoms of the disease appear or on the day of diagnosis. It is forbidden to use it for preliminary or post-exposure prophylaxis, as well as for hospitalization that has already occurred. Clinical trials have shown that in these cases, it is simply ineffective.

In addition, Molnupiravir can affect the growth of bones and cartilage, therefore it is strictly forbidden to take it to minors. It is also not recommended for pregnant women, as researchers found undesirable effects on the fetus in animal tests. The FDA allows pregnant women to take the drug only after a medical examination and only if the potential harm from the drug is significantly lower than the risks associated with the disease. While taking Molnupiravir, the department also recommends refraining from conceiving children, since there are serious concerns about the destructive effect of the drug on sperm.

The FDA has clarified that Molnupiravir is not a substitute for vaccination - in the absence of medical contraindications, it is still highly recommended to get vaccinated against coronavirus. The agency gave the same recommendation for the recently approved drug Paxlovid from Pfizer. It is also released in the form of pills intended for the treatment of coronavirus infection in emergencies and with its own limitations.

It is planned that Molnupiravir and Pasklovid will be taken mainly on an outpatient basis and will reduce the burden on hospitals, reducing the number of hospitalizations. Obviously, a drug for treatment cannot replace preventive methods to prevent or reduce the risk of contracting coronavirus. However, when relatively affordable drugs for coronavirus appear on the market, people may neglect vaccination, believing that drugs in any case will save them from the disease if they become infected.

FDA approves use of Molnupiravir for treatment of coronavirus infection, but with serious restrictions