Valsartan: An Overview
Valsartan is a drug that belongs to the class of Angiotensin Receptor Blockers (ARBs). Its known for its safety profile, and wide-range uses in many heart related conditions, such as congestive heart failure, hypertension and even in diabetic nephropathy.
How Does Valsartan Work?
Valsartan lowers blood pressure by antagonizing the renin-angiotensin-aldosterone system (RAAS); it competes with angiotensin II for binding to the type-1 angiotensin II receptor (AT1) subtype and prevents the blood pressure increasing effects of angiotensin II. Unlike angiotensin-converting enzyme (ACE) inhibitors, ARBs do not have the adverse effect of dry cough (most important advantage over ACE Inhibitors).
Valsartan Contains a Carcinogenic Substance?
Four days ago however, the FDA (U.S. Food and Drug Administration) issued a huge recall of several drug products containing the active ingredient valsartan. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled.
According to the FDA, “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
- They also issued a guide that all patients taking the medication, and to all health care professionals:
Information for Patients and Health Care Professionals
- Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
- To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
- If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
- Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
- Apparently, only three companies are responsible for this act, as they have stated the following:
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Dr. Janet Woodcock, director of the F.D.A.’s Center for Drug Evaluation and Research. “That is why we’ve asked these companies to take immediate action to protect patients.”
We strongly advise all the pharmacies in Libya to start withdrawing the drugs on the following list to avoid any long term complications, also healthcare professionals should be well aware of the issue and make sure that the patients are well oriented of the situation.
Author: Mohamed T. Shembesh
References
The official FDA announcement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm