Looking at the administrative, legal, and safety hurdles that drug companies have to jump through today, I can’t help but feel (some, just a little) pity for them. I’m sure right now there’s a drug company executive waxing nostalgic over a bygone era where they could do some basic safety research, wine and dine a few physicians in their favorite tax haven, and then get their drug out there for public consumption. But times have changed, and getting FDA approval for medications is alot harder than it used to be. And unless your drug is a quasi-herbal supplemental type of thing made in someone’s back yard, getting the FDA to allow it over the counter is even harder. Here’s my list of the top 5 OTC meds that, if they had been released today, would require a prescription.
1. NSAIDS: (Aspirin, ibuprofen, naproxen, etc. . .) These medications are great for pain and for their blood thinning effect by blocking platelet function. But they are also great at eroding stomach lining leading to ulcers, causing kidney damage, reye’s syndrome, hearing problems, etc. . . Would this be allowed OTC by the FDA today? Heck no!
2. Tylenol: (Acetaminophen) It’s “the pain reliever hospitals use most” because it’s relatively benign, it has a low risk of kidney damage, or bleeding, and it’s given to you in a monitored environment. Put that same medication in a household where it can be used in an accidental or intentional overdose and it can very well send you to that same hospital with liver failure. Would this be allowed OTC by the FDA? Probably not.
3. Oral decongestants: (pseudoephedrine) The fact that it’s used to make meth should tell you something. It’s potentially dangerous and powerful stuff. Would this be allowed OTC by the FDA today? Heck no!
4. Primatene Mist: (Inhaled epinephrine) Epinephrine is a very important drug . . . in the treatment of cardiac arrest. So it’s not surprising that this inhaler might have some negative effects on the heart. Luckily it has recently been taken off the market due to the harm it is so obviously causing. To the ozone layer. (see explanation here). Would this be allowed OTC by the FDA today? Heck no!
5. Afrin: (oxymetalozone) If I asked you to name a drug that’s both addictive and can cause a hole in your nasal septum, what would you say? If you said cocaine or afrin, you’re right. Would this be allowed OTC by the FDA today? Heck no!
This list is obviously tilted towards my scope of practice in the pulmonary world. What medications would be on your list?