Every approved drug, whether Rx or OTC, has a safety and efficacy review prior to FDA approving it. Indeed, many clinical trials are stopped due to safety, which means undesirable side effects, I.e, death or other serious health problems. So not all drugs get through the completion of clinical trials. Drugs that have worked well but also have imperfect safety profiles may still be approved as FDA considers risk vs benefit. E.g.chemo drugs.
On the other hand, drugs that have lower efficacy, I.e. may only provide benefit to some patients can be approved if their safety profile is good. Claritin comes to mind. It does not work for everyone, by a long shot.
Another issue is dosing. Clinical studies also determine appropriate doses. And then there is the problem of drug interactions, sometimes one drug can make another more or less potent.
Unfortunately there were no large well controlled trials for this combination. But there are already safety profiles for both drugs and the ZPacks may have more safety issues than the hydochloroquine.
Just listen to the commercials for medications— they always list the major possible side effects at the end, it’s required by law.
I was hoping it would work, as both medicines are cheap and mostly available, but the proof will be in the data.
