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FDA Responds to Drug Shortage: Take Tainted Pills

A huge supply shortage has forced manufacturers to distribute tainted pills, and now the FDA is supporting the move.

What happens when there is a severe shortage of a widely used drug due to dozens of contaminated lots? Well, if you’re the FDA it might cause you to modify your existing quality and safety standards to increase the flow of medicine, tainted or not.

Losartan is the ninth most dispensed drug in the United States. According to Web MD, nearly 60 million prescriptions were written for Losartan drugs in 2016, and it is among a family of active ingredients -- including valsartan and irbesartan -- that are widely used to control blood pressure.

Since July, drug manufacturers, and the FDA, have been struggling to manage a supply bottleneck after it was discovered that a chemical reaction taking place during the manufacturing process was making the drugs carcinogenic.

The results of this meant a huge volume of losartan pills that have been tainted with nitrosamines which, while unintentionally produced, still pose a cancer risk.

But rather than destroying them, drug manufacturers are now being supported by the FDA in distributing these tainted pills anyway, because they say the risks for some patients who abruptly stop using the drugs are worse than the risks they’d face from the short term exposure to the nitrosamines. Going cold turkey could mean a rapid rise in blood pressure which could lead to heart attack or stroke. It’s because of this that the FDA is actually recommending that consumers on losartan pills continue using the tainted ones.

So is this “any port in a storm” logic from the FDA reckless, or is this flexibility actually the most practical solution? It might be the latter. CNN quoted one expert as estimating that the risk for cancer from taking these tainted pills was about one in 8,000 -- over the course of four years.

Still, one unanswered question remains: how long were the pills being tainted by the production process before it was actually discovered? Experts say that, either way, the roulette of pharmacies consistently ordering lots from different manufacturers means patients may not have been taking a tainted product continuously.

According to Web MD, “a common thread among all of these recalls is that the drugs, or ingredients in the drugs, were all made in China or India” and that, “with lower costs sometimes comes lower quality control.”

Meanwhile, the FDA says they expect manufacturers to have replenished supplies of the untainted drugs within six months.

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