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The FDA has released a list of drugs that the public can take in place of the recalled sartan medications. Among the problems with products containing impurities, the agency encouraged patients to continue taking their blood pressure medications. ( Darko Stojanovic | pixabay )
The US Food and Drug Administration publishes a list of relatively safe high blood pressure medications given the recent problems with sartan-based medicines.
On April 4, the agency released 40 angiotensin II receptor blockers containing no nitrosamine impurities, with the goal of helping health professionals to choose options. acceptable treatment for their patients.
Last summer, the FDA recalled many drugs containing valsartan, the active ingredient, due to an impurity, N-nitrosodimethylamine, which is found in products. From then on, the agency has conducted surveys and published public statements for update purposes.
Although the list currently contains only 40 drugs, the 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 is fully known by the agency.
FDA 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, doctors, chemists and other professionals. They also appealed to global regulators to badist them in their investigations.
The team studied how the problem started, how it can solve the problem, how to reduce risk exposure and how to prevent such incidents in the future.
"We have worked to reduce the risk to patients who depend on these drugs, to ensure access to safe ARBs or alternative safe therapies, and to ensure that affected medicines are removed from the chain. US supply, "wrote the FDA.
Although the agency thinks that it still has a lot to do, she believes that she is taking important steps to protect patients from detected impurities.
The blood pressure of drugs shortage is emerging
The elimination of drugs whose test revealed the presence of impurities led to shortages. The FDA allows, for a short time, the distribution of drugs containing impurities higher than the acceptable provisional limits. After weighing the weight of the circumstances, FDA investigators believe that it is crucial that patients have access to these drugs during the manufacture of products without impurities.
The FDA expects pharmaceutical companies to produce losartan without nitrosamine impurities within six months. The agency wants to badure patients that the dangers of not taking drugs, such as stroke, outweigh the low risks badociated with the consumption of drugs containing impurities.
Public health is a priority
The recall could be shocking to the public, especially because it expects products that come out of the shelves to be safe and free of impurities. Although the risks are relatively low according to FDA investigations, this issue is still unacceptable.
The FDA promises to improve its standards for identifying and avoiding genotoxic impurities in the production of the drug. This will remain a topic of great intensity for the agency in the coming months.
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