Recalls, warnings, and alerts
An alert that five additional deaths have occurred in patients with two liquid-filled intragastric balloon systems used to treat obesity. Since 2016, the FDA has received reports of 12 patient deaths involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System, both of which have a maximum placement period of six months. The agency has approved labeling changes to reflect this information and continues to monitor deaths and other related complications, including perforation of the stomach wall or esophagus, acute pancreatitis, and spontaneous hyperinflation. Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems.
A class I recall of the HeartWare Ventricular Assist System by Medtronic due to the possibility of interruption in the electrical connection between the system's power source and its controller. The recall includes 204,017 devices manufactured and distributed between March 2006 and May 2018.
A class I recall of all lots of the Cardiosave Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp. due to a design issue that allows fluid to seep into the device. Affected products were manufactured between Dec. 12, 2011, and April 25, 2018, and distributed from March 6, 2012, to April 26, 2018.
A class I recall of all lots of the HeartMate 3 Left Ventricular Assist System by Abbott due to a malfunction that may cause occlusion of the outflow graft, potentially reducing or stopping pump flow. The recall includes 4,878 devices distributed from Sept. 2, 2014, to the present.
A class I recall of nine lots of the MindFrame Capture LP revascularization device by Medtronic due to the risk of the delivery wire breaking or separating during use. The recall includes 529 devices manufactured between Feb. 3, 2016, and Jan. 14, 2018, and distributed from March 18, 2016, to Jan. 17, 2018.
A recall of two lots of naloxone hydrochloride injection USP (0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject single-use cartridge syringe system) due to the potential presence of embedded and loose particulate matter on the syringe plunger. Affected lots were distributed from February 2017 to February 2018.
A recall of 18,808 units of STAT-Check and Medline resuscitator bags by SunMed Holdings, LLC. The patient port-retaining ring may not fully seat, potentially allowing the patient port to detach during use and delaying treatment. Affected bags were distributed between Feb. 1 and May 13, 2018.
A recall of 36 lots of piperacillin and tazobactam for injection USP (3.375 g/vial and 4.5 g/vial) by Apotex Corp. The affected lots have been found to contain elevated levels of impurities that may result in decreased potency.
A notice that the FDA is evaluating the potential risk of neural tube birth defects involving the brain, spine, and spinal cord in babies born to women with HIV treated with dolutegravir (Juluca, Tivicay, Triumeq). Preliminary data suggest that women who received the drug at the time of becoming pregnant or early in the first trimester appear to have a higher risk for these defects. Clinicians should weigh the benefits and risks of dolutegravir when prescribing antiretroviral agents to women of childbearing age.
An update to a letter to clinicians about the occurrence of Type III endoleaks with the use of endovascular graft systems indicated for endovascular aneurysm repair. Based on new information, the Endologix AFX with Strata device may pose greater risk for Type III endoleaks than other endovascular graft systems. The FDA recommends closely monitoring patients who have the device, with at least annual follow-up to monitor for Type III endoleaks.
Lofexidine hydrochloride (Lucemyra) to mitigate withdrawal symptoms and facilitate abrupt discontinuation of opioids in adults. The oral selective alpha 2-adrenergic receptor agonist is the first nonopioid treatment approved to manage opioid withdrawal symptoms, although it is not a treatment for opioid use disorder. The drug is approved for treatment for up to 14 days and may not completely prevent all withdrawal symptoms. In two randomized trials of 866 adults with opioid dependence who were abruptly discontinuing opioids, withdrawal symptom severity scores were lower in patients treated with the drug compared to placebo, and more patients who received the drug completed the treatment period compared to those who received placebo. The most common side effects include hypotension, bradycardia, somnolence, sedation, and dizziness. The drug was associated with a few cases of syncope, and it also affects the heart's electrical activity, potentially increasing the risk of abnormal heart rhythms. When patients discontinue the drug, they may experience a marked increase in blood pressure. The FDA is requiring 15 postmarketing studies to assess longer-term use and use in children.
Avatrombopag (Doptelet) tablets to treat adults with chronic liver disease who have thrombocytopenia and are scheduled to have a medical or dental procedure. The medication is the first to be approved by the FDA for this indication. The drug, which received priority review, was studied in two trials of 435 patients with chronic liver disease and severe thrombocytopenia who were about to have a procedure that would typically require platelet transfusion. Compared to participants who received placebo, a higher proportion of those who received oral avatrombopag for five days had increased platelet counts and did not need platelet transfusion or any rescue therapy on the day of the procedure and up to seven days later. The most common side effects of the drug were fever, abdominal pain, nausea, headache, fatigue, and edema. The drug may also increase the risk of blood clots in people with chronic liver disease or certain blood clotting conditions.
Epoetin alfa-epbx (Retacrit) to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The drug, a biosimilar to epoetin alfa (Epogen/Procrit), is approved for use before or after surgery to reduce the potential need for red blood cell transfusions due to blood loss during surgery. Common side effects include high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, and others.
Marketing of two catheter-based devices designed to create vascular access in patients with chronic kidney disease who need hemodialysis. The Ellipsys Vascular Access System and the everlinQ endoAVF System are now authorized to create arteriovenous fistulas for patients who need hemodialysis access.
A new indication for tofacitinib (Xeljanz) to treat adults with moderately to severely active ulcerative colitis. The drug is the first oral medication to be approved for chronic use in this population. In placebo-controlled trials, 10 mg of tofacitinib given twice daily induced remission in 17% to 18% of patients at eight weeks. In a trial of patients who achieved a clinical response by week eight, the drug was effective in inducing remission after 52 weeks in 34% of those who received 5 mg twice daily and 41% of those who received 10 mg twice daily. Among patients who achieved remission after eight weeks of treatment, 5-mg and 10-mg doses led to sustained corticosteroid-free remission in 35% and 47%, respectively. The most common adverse events are diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase levels, nasopharyngitis, rash, and upper respiratory tract infection. A boxed warning notes the potential for malignancy and serious infections (e.g., opportunistic infections). The drug was approved in 2012 to treat rheumatoid arthritis and in 2017 to treat psoriatic arthritis.
The Eversense Continuous Glucose Monitoring system, the first to include a fully implantable glucose sensor, for adults with diabetes. The sensor can be worn for up to 90 days. In clinical studies, fewer than 1% of participants experienced a serious adverse event with the implanted sensor. Potential adverse effects associated with insertion, removal, and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, discoloration, and redness. Other risks associated with use of the device include hypoglycemia or hyperglycemia if information provided by the device is inaccurate or alerts are missed.
Erenumab-aooe (Aimovig) for the preventive treatment of migraine in adults. The treatment, which is given once per month by self-injection, is the first in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks. In clinical trials, patients who received the treatment had an average of one to two fewer migraine days per month than those taking placebo. The most common side effects were injection-site reactions and constipation.
First-time generic approvals
Buprenorphine and naloxone sublingual film (2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg) to treat opioid dependence. (Brand name: Suboxone)
Hydromorphone hydrochloride injection USP (2 mg/mL single-dose vials) to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. (Brand name: Dilaudid)
Ertapenem for injection (1 g [base] in single-dose vials), an antibacterial indicated in adults for the prophylaxis of surgical-site infection following elective colorectal surgery and in patients ages three months and older to treat certain moderate to severe infections caused by susceptible bacteria. (Brand name: Invanz)
Clozapine orally disintegrating tablets (12.5 mg) for use as an antipsychotic. (Brand name: Fazaclo)
Phenylephrine hydrochloride injection USP (50 mg/5 mL [10 mg/mL] and 100 mg/10 mL [10 mg/mL]; single-dose vials) to treat clinically important hypotension resulting primarily from vasodilation in septic shock or anesthesia. (Brand name: Vazculep)
Succinylcholine chloride injection USP (200 mg/10 mL [20 mg/mL]; multiple-dose vials) to serve as an adjunct to general anesthesia, to facilitate tracheal intubation, or to provide skeletal muscle relaxation during surgery or mechanical ventilation. (Brand name: Quelicin)
Phytonadione tablets USP (5 mg) to treat anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives, hypoprothrombinemia secondary to antibacterial therapy, hypoprothrombinemia secondary to administration of salicylates, and hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas in combination with bile salts. (Brand name: Mephyton)
Tadalafil tablets USP (2.5 mg, 5 mg, 10 mg, and 20 mg) to treat erectile dysfunction and/or the signs and symptoms of benign prostatic hyperplasia. (Brand name: Cialis)
Oxybutynin chloride gel (10%), a muscarinic antagonist indicated to treat overactive bladder with symptoms of urinary incontinence, urgency, and frequency. (Brand name: Gelnique)
Methylphenidate hydrochloride for extended-release oral suspension (300 mg/60 mL total volume, 600 mg/120 mL total volume, 750 mg/150 mL total volume, and 900 mg/180 mL total volume [5 mg/mL]), a central nervous system stimulant indicated to treat attention deficit hyperactivity disorder. (Brand name: Quillivant XR)
Colesevelam hydrochloride tablets (625 mg) as an adjunct to diet and exercise to reduce LDL cholesterol levels in adults with primary hyperlipidemia as monotherapy or in combination with a statin and reduce LDL cholesterol levels in boys and postmenarchal girls, ages 10 to 17 years, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after no response to an adequate trial of diet therapy. (Brand name: Welchol)
Note: The FDA states that drugs are not always commercially available immediately after approval.