F.D.A. Regulation “Guaranteed Failure” of a Powerfully Effective Anti-Pain Drug That, Unlike Opioids, Is Nonaddictive

Christmas is a time of good will and hope. I should have worked harder to post an entry that exudes both. Instead I provide another example of how government regulation increases our pain.

(p. A19) Injectable Toradol IV/IM is a great drug. Many doctors, primarily in emergency rooms, use it daily. Yet most patients would rather swallow a pill than get a shot. Responding to this well-known preference, Syntex developed an oral version and submitted it to the FDA. The agency approved Toradol Oral in 1991 but gave it a label that essentially precluded its use—limiting the drug’s dosage to about a third of its effective amount, imposing a strict limit of five days of use, and mandating that the oral tablets follow an injection or intravenous dose of Toradol IV/IM.

The upshot? You could receive Toradol Oral from your pharmacist only after you had received it via an injection, say, from an emergency-room doctor. The requirement—along with the super low dose and limited duration—guaranteed failure.

. . .

Toradol IV/IM is well-established, relatively safe and works about as well as morphine to reduce pain. It’s also nonaddictive and abuse-proof because it doesn’t provide an opioid “high.” What we really need is an oral formulation with the proper dose for use at home, at work and while traveling. Such a drug could help alleviate the opioid crisis.

For the full commentary see:

Charles L. Hooper. “How the FDA Helped Fuel the Opioid Epidemic.” The Wall Street Journal (Wednesday, May 3, 2023 [sic]): A19.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date May 2, 2023 [sic], and has the same title as the print version.)

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