Two different safety concerns that may affect people with diabetes emerged in the last week, with Medtronic recalling certain insulin pumps and the U.S. Food and Drug Administration (FDA) requesting that a manufacturer withdraw a weight-loss drug from the marker.
Medtronic recalls some MiniMed pumps after death due to malfunction
Last Wednesday, the FDA announced that Medtronic is recalling some MiniMed 600 Series insulin pumps due to the potential for incorrect insulin dosing that has already caused thousands of injuries and one death. The problem lies in a missing or broken retainer ring that’s designed to lock the insulin cartridge in place within the pump.
The affected models include the 630G and 670G versions of the pump, manufactured before fall 2019 (see the FDA page for details). There are over 322,000 pumps affected by this recall. If you have an affected pump, Medtronic advises examining the retainer ring and making sure your insulin cartridge locks into the pump. If the ring is loose, damaged or missing, or if your insulin cartridge doesn’t lock into place, stop using the pump and contact Medtronic for a replacement. If this is the case, you’ll need to perform manual insulin injections according to your doctor’s instructions.
Medtronic also recommends that you check your pump’s retainer ring at each insulin change, or if you accidentally drop your pump.
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FDA requests withdrawal of weight-loss drug Belviq
The FDA has requested that the manufacturer of the weight-loss drug lorcaserin (marketed as Belviq and Belviq XR) withdraw the drug from the market, due to safety concerns raised by a clinical trial. Last month, the agency warned that according to a recent clinical trial, the drug may increase the risk of cancer, but held off on making any recommendations to users of the drug, as noted in a Healio article about the situation.
Now, the FDA has asked the manufacturer, Eisai, to take voluntary action by withdrawing the drug, pending a final review of the evidence and official action by the agency. Belviq was approved by the FDA in 2012 to assist with weight loss, in combination with a reduced-calorie diet and increased physical activity. The manufacturer was required to conduct a clinical trial at that time to evaluate cardiovascular risk, but the trial instead highlighted increased rates of pancreatic, colon, lung and other cancers among participants who took the drug.
The FDA is also recommending that doctors stop prescribing the drug, and that they ask patients to stop taking it. Right now, no special cancer screening is recommended for current or former Belviq users.