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Letter from the Editor
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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We can make a difference!
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Dave Joffe
Editor-in-chief
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Did You Know: Treating Men With BPH Increases Risk for Type 2 Diabetes by 30%
A common prostate cancer drug has been linked to type 2 diabetes, in a new published study. Researchers say that men on the drugs dutasteride or finasteride should not stop taking them, but instead speak with their doctors about their individual risk for the condition. Men taking 5-alpha-reductase inhibitors had the risk of developing type 2 diabetes increase by a third, according to research published in the British Medical Journal. These findings will be particularly important for health screening in older men who are already typically at a higher risk of type 2 diabetes. The researchers found that men who used dutasteride or finasteride to treat benign prostatic hyplasia had a roughly 30 percent spike in type 2 diabetes. 5-alpha-reductase inhibitors help men with symptoms of enlarged prostates, such as urinary flow problems, by reducing hormone production. To investigate the incidence of new onset type 2 diabetes mellitus in men receiving steroid 5α-reductase inhibitors (dutasteride or finasteride) for long term treatment of benign prostatic hyperplasia they evaluated 8,231 men on dutasteride and 30,774 men on finasteride in the CPRD (Clinical Practice Research Datalink), a real-world research service supporting retrospective and prospective public health and clinical studies. 2,081 new onset type 2 diabetes events (368 dutasteride, 1,207 finasteride, and 506 tamsulosin) were recorded during a mean follow-up time of 5.2 years. The event rate per 10, 000 person years was 76.2 (95% confidence interval 68.4 to 84.0) for dutasteride, 76.6 (72.3 to 80.9) for finasteride, and 60.3 (55.1 to 65.5) for tamsulosin. There was a modest increased risk of type 2 diabetes for dutasteride and finasteride compared with tamsulosin. From the results it was concluded that the risk of developing new onset type 2 diabetes appears to be higher in men with benign prostatic hyperplasia exposed to 5α-reductase inhibitors than in men receiving tamsulosin, but did not differ between men receiving dutasteride and those receiving finasteride. Additional monitoring might be required for men starting these drugs, particularly in those with other risk factors for type 2 diabetes.
BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1204 (Published 10 April 2019)
Diabetes in Control gratefully acknowledges the assistance of the following pharmacy doctoral candidates in the preparation of this week’s newsletters:
Dahlia Elimairi, Pharm D student, UC Denver Skaggs School of Pharmacy
Ghazal Blair, Pharm.D. Candidate 2019, LECOM School of Pharmacy
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