Beware the manufacturing process in ARBs.

More complexities have been added the treatment of hypertension making some of the drugs losartan, valsartan, irbesartan unsafe because they contain toxins which can cause cancer.  Unfortunately the manufacturing process  has altered in China, (possibly India) which is the chief source of the drug to USA and elsewhere, raising the levels of  these toxins much higher. FDA officials believe that U.S. patients have been ingesting ARBs containing carcinogenic impurities for approximately 4 years; they estimate that for every 8000 patients taking the highest dose of an affected product for the full 4 years, one new cancer above the background incidence would be expected.

The Wall Street Journal reported that as many as 2 million patients had probably been exposed to the impurities, N-nitrosodimethylamine (NDMA) and N-nitroso-N-diethylamine (NDEA). Most recently, a third impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), has been identified in an ARB product, resulting in a new recall.

Although some products containing valsartan, irbesartan, or losartan remain commercially available in the United States, patients and the health care system have paid a steep price beyond the health concerns and anxiety arising from exposure to recalled products. One third of all FDA drug recalls issued since July 2018 have involved ARB-containing products, and together the recalls have affected one sixth of U.S. ARB manufacturers. Some unaffected manufacturers have increased valsartan prices twofold, threefold, or even more. The lack of selected ARB products has also placed pressure on the supply chain for non-recalled ARBs.

Though the FDA pinpoints a specific formulation and manufacturer in each recall, the dissemination of, and response to, FDA reports is uneven. Patients and clinicians may hear about recalls through the news media, social media, pharmacies, health care providers, or friends. Moreover, the public may hear about a recall of a “hypertension drug” but not know the specific product and manufacturer. Thus, recalls may trigger unnecessary concern among many people receiving antihypertensive therapy — and may be ignored by people who take ARBs for heart failure or chronic kidney disease. The burden of response has fallen to clinicians, pharmacies, and health care systems, most of which lack the infrastructure or resources to respond promptly to patients’ concerns.

So be aware of the problems that you are going to encounter. Be prepared to answer questions. Be prepared to change patients medications.

 

 

Hypertension Hot Potato — Anatomy of the Angiotensin-Receptor Blocker Recalls
J. Brian Byrd, M.D., M.S.C.I., Glenn M. Chertow, M.D., M.P.H., and Vivek Bhalla, M.D.March 13, 2019
DOI: 10.1056/NEJMp1901657

 

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shaheenmoin

I am a Professor of Medicine and a Nephrologist. Having served in the Army Medical College, Pakistan Army for 27 years I eventually became the Dean and Principal of the Bahria University Medical and Dental College Karachi from where I retired in 2016. My passion is teaching and mentoring young doctors. I am associated with the College of Physicians and Surgeons Pakistan as a Fellow and an examiner. I find that many young doctors make mistakes because they do not understand how they should answer questions; basically they do not understand why a question is being asked. My aim is to help them process the information they acquire as part of their education to answer questions, pass examinations and to best take care of patients without supervision of a consultant. Read my blog, interact and ask questions so that I can help you more.

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