Blood Pressure Medication Recall
Recently, the federal Food and Drug Administration (FDA) announced a voluntary recall of a number of blood pressure medications because of contamination of the active ingredient with a probable human carcinogen (cancer causing) impurity. The medications tagged are in a class of popular and effective blood pressure lowering agents called ARBs (angiotensin receptor blockers) also known as sartans; they are valsartan, losartan, irbesartan, and olmesartan. Some of these drugs are made in a single tablet in combination with HCTZ (a diuretic or fluid pill) and /or amlodipine (a calcium channel blocker). These two BP meds are not incriminated unless they are combined in a single tablet with an ARB.
When organic compounds are synthesized in the laboratory, appropriate precursors (ingredients) are chemically combined to form the desired end-product. In the case of pharmaceuticals, the end-product is the active component of the drug. The chemical reaction also typically produces unwanted by-products and the active ingredient must be purified to remove these substances or the synthetic process altered to reduce the amount of by-product produced. The chemical reaction used to synthesize an ARB results in the by-product NDMA (nitrosodimethylamine). The FDA is aware of this contaminant and has guidelines that allow for very minimal amounts of NDMA to be present in an ARB’s active ingredient. Products that do not exceed these levels are deemed to be safe and do not present a health hazard. The ARBs involved in the recall were found to exceed these threshold amounts.
NDMA is an organic chemical that is known to cause cancer in animals. It is used in labs to induce cancer in animals for research purposes. The assumption is that it is carcinogenic to humans with exposure over a long period of time. Expert scientists have estimated that over the course of a person’s lifetime, consuming a micro-drop of NDMA could result in less than one additional case of cancer for every 100,000 people. To put that estimate in perspective, approximately 30 % of US citizens will experience some form of cancer in their lifetime. Additionally, there have been no quality investigations that have associated ARB use with cancer. So, the health risk of using ARBs contaminated with small amounts of NDMA is very small, if any.
The recalled lots of ARBs thus far represent a small fraction of those that are available and distributed. Anyone taking one or the medicines listed can contact the pharmacy where they filled their prescription and determine if the medicine they were given is on the recall list.
FDA reports show that the active ingredient in the recalled drugs was manufactured in pharmaceutical laboratories in China and India and the drugs have been on the market for at least 4 years. That fact is not surprising since 40% of finished drugs and 80% of active ingredients in drugs offered in the US are produced and imported from overseas facilities, the great majority from China. China has proclaimed that in the near future, they will become the “World’s Pharmacy”. The FDA is charged with the responsibility of ensuring the quality of these drugs. Practically speaking, the FDA has to be challenged to conduct frequent and thorough inspections of pharmaceutical facilities in these distant countries.
The good news is that the FDA acted appropriately in notifying the public and issuing the recalls. Also good is the fact that consuming the allegedly contaminated ARBs likely produces little risk. The disturbing news is that the tainted drugs were available for use for at least 4 years.
Please remember that the ARBs listed are excellent drugs for controlling hypertension and preventing heart disease, kidney disease, and strokes. It is strongly recommended that anyone taking these medications that were not in the small percentage of the recalled batches, continue to do so. If you have concerns, you should discuss them with your healthcare provider.
Dr. Tippet is the founder of Comprehensive Quality Healthcare Providers, an internal medicine concierge practice, located at 1210 Commerce Dr. Suite 106 Greensboro, Ga. 30642. He can be reached at 706-510-3659. Visit his webpage at www.drtippett.com