In what has become an all-too-familiar pattern in recent years, the U.S. Food and Drug Administration announced another round of recalls pertaining to medications aimed at helping patients suffering from blood pressure and heart failure issues. According to the FDA, the recall was prompted due to concerns many of these medications contained ingredients considered to be carcinogenic.
While currently there are no adverse effects that have been reported to the FDA about these medications, agency officials are concerned at what they perceive to be an alarming trend. Over the past several years, 30 different blood pressure medications have been subjected to recalls for these and other issues, with the vast majority originating from factories located in India and China, where more and more drugs used in the United States are being manufactured.
At the center of this current recall is Hetero Labs, a drug manufacturing facility based in India. According to FDA officials and facility inspectors, employees at Hetero Labs shredded a variety of documents ahead of the arrival of FDA inspectors in 2016, all the while failing to record exactly what was shredded. Along with these allegations, it is also noted that in 2017 a warning was issued to this facility by the FDA, citing such violations as failing to inspect batch discrepancies, employees failing to wash hands, and a failure to wash and sanitize equipment.
Based on data obtained from the FDA, the agency has stepped up its inspections of foreign factories in recent years, and has actually inspected more factories located on foreign soil than those located in the United States. However, a report from the Government Accountability Office has also pointed out that since mid-2016, more than 1,000 foreign factories have yet to receive a recent inspection. According to the GAO, a major part of the problem with a lack of inspections is the failure of the FDA to fill inspector positions, of which 15% of factory inspector jobs are still open.
Due to the serious and potentially life-threatening issues that could result from the impurities supposedly found in these various medications, the FDA has announced numerous investigations into the matter. According to researchers from Samford University who are closely monitoring the recalls, part of the problem stems from scientists at Hetero Labs being unaware many of the active ingredients they were using in medications could in fact form compounds that were carcinogenic.
In many cases regarding overseas production facilities, a spokesperson for the FDA stated the agency relies on what it calls a “risk-based inspection strategy.” In these instances, the agency chooses to put more of its inspection time and resources into facilities falling into the “high-risk” category, meaning ones that have had higher numbers of violations. According to the FDA, since 2017 this has resulted in a decline of inspections for facilities in China, but has led to a sharp increase in the inspection of facilities in India.
While many patients are naturally concerned about the recalls and how these events will impact the healthcare they receive, the FDA states there are many other options already available to doctors and hospitals. For example, the agency notes pharmacists can offer alternative medications that are similar in nature but are not affected by any recalls, or doctors can instead choose to prescribe different medications that treat the same conditions.
Whatever the case may be as it relates to patient care, the FDA and healthcare professionals agree problems within the drug manufacturing industry need to be addressed and corrected as quickly as possible. Otherwise, more recalls will be necessary, putting patients at increased risk in various ways.
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