FDA admits Pfizer antiviral oral drug paxlovid causes life-threatening reactions when taken with common medicines
By matthewdavisdw // 2022-01-05
Copy
 
The antiviral oral drug, paxlovid, that was developed by Pfizer to treat the Wuhan coronavirus (COVID-19) can cause severe or life-threatening effects when used with common medications. The pill is also not recommended for people with severe kidney or liver disease. On Dec. 22, the Food and Drug Administration (FDA) granted emergency use authorization for paxlovid. The drug supposedly prevents COVID patients with initial symptoms from becoming too ill and getting hospitalized. But the agency is now admitting that the drug can be fatal when used with common medications like statins, blood thinners and some antidepressants. Pavloxid is recommended for patients 12 years old and above with mild to moderate symptoms of COVID-19. Patrizia Cavazzoni, FDA’s director for Drug Evaluation and Research, said that the granting of EUA to paxlovid will provide a new tool to fight the virus as new variants emerge. “Paxlovid promises to make antiviral treatment more accessible to patients who are at risk for progression to severe COVID 19,” Cavazzoni said. The Biden administration in November had already purchased some 10 million courses of paxlovid. It inked an agreement with Pfizer amounting to $5 billion. The paxlovid cocktail is made up of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir. Ritonavir suppresses a key liver enzyme called CYP3A, which metabolizes many medications, including nirmatrelvir. But when the paxlovid treatment is paired with other medications that are also metabolized by the CYP3A enzyme, the ritonavir component may boost the co-administered drugs to toxic levels. Pfizer announced in December that the pill can reduce the risk of hospitalization and death by 89 percent when taken by those with COVID-19 symptoms. Pfizer CEO Albert Bourla on Dec. 8 told CNBC that shipments of the pill have already arrived in the United States. Paxlovid is said to be effective when taken by a suspected COVID-19 positive within three days. Data also suggests that it will be effective in combatting the omicron variant. But doctors and researchers agree that the pill will not stop the transmission of the COVID virus. (Related: Pfizer, Merck launch trials for new oral COVID-19 drugs you’ll have to take ALONGSIDE vaccines.) Some doctors also expressed concerns that the availability of the oral drug will lead people away from vaccination. According to the Centers for Disease Control and Prevention (CDC), millions of Americans remain unvaccinated.

UK approves use of second oral COVID-19 pill

Meanwhile, the U.K.’s drug regulator also approved the use of paxlovid. According to the Medicines and Healthcare products Regulatory Agency (MHRA), paxlovid can be given to to people aged 18 and older with mild to moderate symptoms and who are at risk of developing severe disease. For those who are particularly vulnerable to COVID-19, “this treatment could be life-saving,” said June Raine, chief executive of the MHRA. The omicron coronavirus variant rapidly spreading across the U.K. has squeezed the availability of effective treatment options. The variant has mutations that can dodge the protective effects of Roche/Regeneron’s monoclonal antibody ronapreve, which has been used for some time in the country. Paxlovid is the second oral antiviral to be conditionally approved for use in the United Kingdom. MSD/Ridgeback’s molnupiravir was also authorized on November 4, 2021. Both are used to treat people at home and both medicines must be given within five days of symptoms. Watch the video below to learn more about the side effects of Pfizer’s COVID-19 vaccine.
Copy