Drug manufacturer KVK-Tech, Inc. has issued a voluntary recall of blood pressure drug betaxolol after oxycodone was discovered on the production line. The recall notice, published Sept. 29, 2023 by the U.S. Food and Drug Administration (FDA), says the precautionary measure is being taken following the discovery of a single 5 mg Oxycodone Hydrogen Chloride (HCl) tablet on the packaging line after the batch in question was packaged and distributed to wholesalers and retailers. The recall offers no explanation or subsequent investigation into the rogue oxycodone pill being found on the production line as the drug was being bottled for patient consumption.1 2
The two pills look similar in appearance, raising concerns that the average patient would not be able to differentiate the two drugs. KVK-Tech has since notified its distributors and customers to arrange for a return of all affected product, and asks anyone affected by the recall who may have experienced adverse effects to contact the FDA’s MedWatch Adverse Event Reporting program.2
Recall Suggests Infants, Children and Elderly Patients at Higher Risk of Negative Opioid Impacts
The recall statement warns that, per the betaxolol package insert, the medication could cause a “decrease in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration.” It adds, “Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid.”2
Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol. Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk.”2
4,500 Drugs and Devices Recalled by FDA Every Year
Consumers often look to the FDA to ultimately decide whether or not a medical product is safe for them and their families. According to the USA.gov website, the FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.3
Recalls occur when a medical product is found to be defective or potentially harmful. Over 4,500 drugs and devices are recalled by the FDA every year, often after the FDA has previously given the product or device the green light for safety. Usually, by the time the FDA decides to recall a product or device, the item has already been widely prescribed, ingested, or implanted—often for several years. This is why FDA approval alone may not be the most reliable litmus test for determining if a pharmaceutical product is safe or beneficial.
Vioxx Claimed 60,000 Lives After Gaining FDA Approval
One of the deadliest FDA recalls dates back to 2004 when Merck’s Vioxx was finally pulled from shelves after claims that the popular arthritis drug caused consumers’ heart attacks and strokes. It was subsequently found that Merck scientists manipulated clinical trial results in favor of the arthritis drug and buried evidence that the drug increased the risk of heart attack. The drug originally underwent an expedited review process for fast tracked FDA licensure and was on the market five years before finally being pulled from shelves in 2004.4 5
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1 Smith K. Blood pressure medicine recalled after oxycodone tablet found on packaging line. Fox 8 News Oct. 7, 2023.
2 Press Release. KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged U.S. Food and Drug Administration Oct. 3, 2023.
3 USA.gov. The Food and Drug Administration.
4 Berenson A et al. Despite Warnings, Drug Giant Took Long Path to Vioxx Recall. The New York Times Nov. 14, 2004.
5 Compton K. Vioxx. Drugwatch Sept. 5, 2023.