NEW ANTI-VIRAL DRUGS HAVE SERIOUS CONCERNS

On May 5, 2022, DrGOpines.com published an article titled “New Anti-Viral Drugs Receive Emergency Use Authorization.” In it, two new drugs for COVID-19 were introduced having received approval from the U.S. Food and Drug Administration. The two were Paxlovid and Lagevrio. These drugs were promising additions to the panel of treatments for this very troublesome virus.

My reaction to the announcement was disappointment for two reasons: 

     1. Despite reducing hospitalizations, anti-virals did not shorten the course of the illness.

     2. Despite improving symptoms during 5 days of treatment, symptoms recurred after the 

           drug was stopped. 

These two drugs passed FDA muster, but were just not as effective as they should be.

To add another layer of concern about these new anti-virals, the FDA recently presented an updated list of drugs that should NOT be taken with PAXLOVID. The list contained over 120 drugs that should either NOT be taken or have a dosage adjustment. 

The list contains many drugs used commonly such as

         Oral contraceptives

         Anti-migraine drugs

         Cardiac Arrhythmia drugs

         Anti-convulsants

         Antibiotics

         Anti-coagulants

         Cholesterol-lowering drugs

Examples of drugs that SHOULD NOT BE TAKEN are:

    Xarelto, Erythromycin, Rapaflo, Uroxatral, Brilinta, Lipitor, Zocor, Mevacor, Triptans, Stendra, 

        Salmeterol, Colchicine, Halcion. 

These are drugs for sleep, cholesterol, urine flow, migraine headaches, gout, asthma, and blood thinners. They are all used frequently.

Examples of drugs that SHOULD NOT BE TAKEN UNLESS ABSOLUTELY NECESSARY are:

    Eliquis, Biaxin, Sporonox, Nizoral, Flomax, Digitalis, Decadron, Triptans, multiple

        tranquilizers, hydrocodone, oxycodone, fentanyl.

These are blood thinners, antibiotics, anti-anxiety, migraine, analgesic, anti-fungal drugs, and many others. 

ONE HUNDRED TWENTY (120) DRUGS

In addition, the FDA has published a checklist of prescribing requirements that outline criteria that must be met before Paxlovid can be prescribed. The checklist is not required to prescribe Paxlovid, but is intended to assist clinical decision-making.

Dr. G’s Opinion: I’m not impressed. These anti-virals either don’t work or have numerous dangerous drug interactions that put the patient at risk. Some drugs are ok to stop for several days or weeks, during treatment, but many are not. The doctor has to decide if the limited benefit of prescribing the anti-viral is worth the risk of stopping the other drug. That’s a tough decision. My impression is the limited efficacy of Paxlovid isn’t worth the risk of stopping one of 120-plus drugs with which it interacts. A list of drugs that long says something isn’t right about Paxlovid, or the FDA was careless in their scrutiny of the drug.

Plus there’s the major issue of rebound COVID-19 infections occurring after completing a course of Paxlovid. Several reports state that COVID-19-positive patients after completing a course of Paxlovid, and testing negative for the virus, are becoming sick again and testing positive for COVID-19, once again. The reasons speculated are Paxlovid is only partially effective against Omicron, the dominant variant currently, or the drug is being started too early in the course of the illness. Whatever the cause, family physicians are hesitant to prescribe Paxlovid because of the serious number of drug interactions.

References: News FromThe Food and Drug Administration: “Paxlovid Drug Interaction Screening Checklist Updated.” JAMA 2022 October 4;328(13):1290.

https://www.covid19treatmentguidelines.nih.gov/therapies/Paxlovid-drug-drug-interactions/

News and Analysis: “From positive to negative to positive again—The Mystery of Why COVID-19 Rebounds in Some Patients Who Take Paxlovid” JAMA 2022 June 28;327(24):2380-2382.