The U.S. Food and Drug Administration releases a list of blood pressure medications that are relatively safe amid the recent issues surrounding sartan drugs.
On April 4, the agency published 40 Angiotensin II Receptor Blockers that do not have nitrosamine impurities, with the goal of helping health care professionals decide on acceptable treatment options for their patients.
Last summer, FDA recalled numerous drugs with active ingredient valsartan due to an impurity, N-nitrosodimethylamine, found in the products. From then on, the agency continuously conducted investigations and released public statements for updates.
Although the list contains only 40 drugs at the moment, FDA hopes to add more in the coming weeks. They will continue to do more testing and update the list as more information about other drugs become fully known by the agency.
FDA Works Overtime
When the recall was first announced, the FDA responded in a consistent and thorough manner. They set up an internal team of pharmacists, toxicologists, physicians, chemists, and other professionals. They also tapped global regulators to help with the investigations.
The team studied how the issue started, how they can address the existing problem, how to alleviate exposure, and how to prevent such incident from happening in the future.
"We've remained steadfast in making sure we minimize risks to patients who rely on these medications, ensure access to safe ARBs or acceptable alternative therapies, and ensure affected medications are removed from the U.S. supply chain," the FDA wrote.
Although the agency thinks they still have lot more to do, they believe that they are making significant steps to safeguard patients from the detected impurities.
Blood Pressure Drugs Shortage Looms
The removal of drugs that tested positive for the impurities have led to shortages. With this, the FDA allows, for a short period, the distribution of medications with impurities higher than interim acceptable limits. After weighing down the circumstances, FDA investigators think it is crucial that patients have access to these medications while impurity-free products are being manufactured.
FDA expects pharmaceutical companies to produce losartan without nitrosamine impurities within six months. The agency wants to assure the patients that the dangers of not taking the drugs, such as stroke, outweigh the low risks linked to the consumption of impurity-containing drugs.
Public Health Is Priority
The recall might come as shocking for the public, especially because they expect products coming off shelves to be safe and free from impurities. Although the risks are relatively low as per FDA investigations, this issue is still unacceptable.
FDA promises to improve on their standards of determining and avoiding genotoxic impurities during drug production. This shall remain to be an aspect of intense focus for the agency in the coming months.
