Under normal circumstances, it is highly unlikely that a U.S. consumer purchasing a popular over-the-counter drug like Excedrin would run the risk of finding -- and then taking -- a powerful, prescription-only painkiller in the bottle of pills. The times, apparently, are not normal. The Food and Drug Administration issued a warning Monday that certain over-the-counter pills may have accidentally been packaged with powerful, prescription-only opiod drugs. The consequences of the mix-up could be deadly.
So far, thank goodness, there have been no reports of packaging mix-ups or of reactions or illness to consumers as a result of what are described as "major" manufacturing problems at a plant in Nebraska. The Novartis facility produces over-the-counter formulations like Excedrin and Gas-X as well as physician-prescribed painkillers -- Percocet, Endocet, Opana and Zydone -- sold by Endo Pharmaceuticals. Officials are worried that pills could become stuck in machinery and carry over to the packaging of other products.
Novartis has stopped production at the Lincoln plant and issued a recall of over-the-counter products -- including Excedrin, NoDoz, Bufferin and Gas-X -- on Sunday. That's a wise precaution, given the widespread use of the products and the possibility of a packaging mix-up.
The FDA says it will not recall the painkillers because it considers them essential to many patients, and thinks the risk to patients from mispackaged pills is low. That may be true, but consumers still should make sure that the tablets they ingest are consistent in shape, size, color and marking. That's always a good idea, but in this instance it is even a better one. Doing so could prevent illness -- or save a life.
The problems at the Novartis plant are egregious. The company might have prevented them, in fact, had it acted responsibly in the past. The facility was cited for quality control issues last summer, according to the FDA. Agency reports indicate that the company did not properly investigate 166 claims of mixed-up pills in Novartis bottles since 2009, and that the company failed to adequately review 223 complaints received by the plant last year. That suggests that Novartis continued to seek profits rather than promptly address safety issues by halting production. Officials, of course, deny that, but it seems clear that the company forthrightly addressed the issue only after regulators publicly called its hand.
The investigation at the Nebraska plant continues, and FDA regulators have yet to indicate what, if any, penalties might result from the problems there. Given recent history at the facility, sanctions seem inevitable. When they come, they should be strong enough to remind manufacturers of over-the-counter and prescription drugs that the health and safety of the public should always trump the desire to take shortcuts and to ignore complaints in the pursuit of profits.