Irbesartan: In late October 2018, a pharmaceutical company in India recalled 22 batches of irbesartan, which was reported to be contaminated with NDEA. 10 Updates and press announcements regarding the ARB recalls can be found here. Unfortunately, the list of recalled products has continued to expand as more manufacturers that produce ARBs in the same class as valsartan, including products containing losartan and irbesartan, have discovered lots of drugs contaminated with NDMA or NDEA.
6,10 Other agents involved in the recent ongoing recalls included certain lots of amlodipine-valsartan combination tablets and amlodipine-valsartan-hydrochlorothiazide combination tablets that were contaminated with N-nitrosodiethylamine (NDEA). The list of recalled drugs eventually covered more than 50% of valsartan products on the U.S. 9,10 The affected drugs were sold in the U.S.
#Cardinal chains level 80 series#
Valsartan: In July of 2018, the FDA began to announce a series of voluntary recalls for several lots of valsartan-containing products owing to contamination with the possible carcinogen known as N-nitrosodimethylamine (NDMA). The FDA has many roles in the drug-recall process, including overseeing a manufacturer’s strategy, evaluating the appropriateness of the recall, and classifying the drug recall ( Table 1). Therefore, it is imperative that pharmacists be acquainted with the FDA’s drug-recall process and be prepared to answer patient questions and address their concerns without compromising patient care. In light of the growing number of recent drug recalls involving specific lots and manufacturers of the generic versions of angiotensin II receptor blockers (ARBs) such as losartan, valsartan, and irbesartan, pharmacists are likely to receive many inquiries from concerned patients about the nature of these recalls and the possible effects on their medication. 7,8 The report also revealed that more than 2,500 facilities remained uninspected over a 5-year period, and more than 1,600 facilities, including 400 located outside the U.S., had not been inspected in 10 years. The KHN report states that from January 2013 to October 2018, almost 8,000 medications were recalled by pharmaceutical companies across the United States and abroad. Ongoing recalls have gained a noteworthy amount of attention and increased concerns among healthcare providers and the patients they treat. 5,6 According to a recent report conducted by Kaiser Health News (KHN), thousands of drugs are recalled annually after reaching pharmacies the recalls eventually impact patients when prescriptions are filled. 5 While these manufacturing processes aid in keeping the costs of medications down, this has also created a supply chain that can be challenging to keep track of, which may increase the number of drug recalls. 4Īpproximately 80% of medications that Americans take contain some component manufactured abroad, primarily in China and India. 4 Regardless of the reason for the recall, the FDA’s role is to supervise a manufacturer’s strategy and assess and ensure the appropriateness of its handling of the recall. However, sometimes a drug is recalled after the FDA raises concerns. The majority of drug recalls are voluntary the manufacturer identifies an issue and recalls the affected drug. 2 Recalls may be conducted as a voluntary action by the manufacturer or supplier by request from the FDA or by a legally mandated order from the FDA. 1 Drugs may be recalled for an assortment of reasons including safety, mislabeling, contamination, and deviations in strength or potency. 1 According to the FDA, a recall is defined as an action executed by a manufacturer at any time to remove a defective or harmful drug product from the market when the drug is discovered to be in violation of laws and regulations administered by the FDA. Pharmacists should also be prepared to answer patient and prescriber questions and concerns when a drug recall occurs and be instrumental as well in ensuring that patient care is not interrupted or compromised.Ī drug recall is the most effective means of protecting the public from a defective or potentially harmful product. In light of the increasing number of drug recalls recently, particularly those pertaining to certain antihypertensives, it is imperative that pharmacists be acquainted with the FDA drug-recall process and have measures in place to handle recalls. ABSTRACT: Drug recalls occur routinely every year, and the FDA has implemented measures to ensure that these recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market.
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