April 27, 2019

We have all watched the FDA do some crazy things but I believe they have just set the new standard in “stupidity” with their latest decision on the contaminated ARB, losartan.  According to USA Today the FDA will allow certain lots of losartan that contain trace amounts of a potential carcinogen to be shipped to pharmacies. In their own words, the temporary measure is meant “to avert a shortage of the critical medication.” Allowing “losartan with tiny amounts of a nitrosamine impurity will not increase a person’s cancer risk, the FDA says,” whereas “if people discontinue or can’t get the drug for conditions such as hypertension, heart failure or kidney disease, it could put them at risk or force them to switch to another medicine.”

You have to wonder about a couple of things. Firstly, why didn’t the FDA take the same attitude when they pulled Avandia and Actos, and secondly why, when there are 5 other generic ARBs and one brand ARB on the market, would they be so worried about a patient having to change a medication? My own opinion is that they are being influenced by the PBMs and payers, as losartan is the cheapest ARB available. 

This raises the question of prescriber and pharmacist liability. If you knowingly give your patient a carcinogenic drug are you liable? I am going to bet YES, as indicated by this note in Bloomberg News: “As the FDA and other drug agencies work to contain the damage from a massive recall of blood pressure drugs, litigation stemming from the mess is just getting started. In fact, one lawyer involved predicts thousands of lawsuits will hit the courts within two years.”

I would be very hesitant to put my name on or dispense any prescriptions for these products and would likely stay away from any of the generics altogether. 

To learn more about the contamination problem, click here.

 

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Dave Joffe

Editor-in-chief