Recalls, market withdrawals, and warnings
A warning about cases of a rare, serious infection of the genitals and surrounding area in patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors. From March 2013 to May 2018, the agency identified 12 cases of the infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, in seven men and five women within several months of the patients starting an SGLT2 inhibitor. All 12 patients were hospitalized and required surgery, some developed complications, and one died. A new warning about this risk will be added to the prescribing information of all SGLT2 inhibitors, as well as to the patient medication guide.
A recall involving a field correction of about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to issues at high altitudes. Patients who are at altitudes above 3,200 feet (975 m) may experience interruption and/or inability to start therapy, potentially leading to hemodynamic instability. The company is developing a software correction to address the issue and anticipates that installation will begin in February 2019.
A class I recall of all lots of VITEK 2 gram-positive antimicrobial susceptibility testing cards with oxacillin and cefoxitin tests by bioMérieux due to false results for some strains of methicillin-resistant Staphylococcus aureus. The recall includes nearly 14 million devices manufactured and distributed since Feb. 8, 2017.
A recall of all sterile drug products compounded by Pharm D Solutions, LLC, due to a lack of sterility assurance. A routine FDA inspection raised concerns about risk of contamination. The recall includes all compounded sterile drug products dispensed from September 2017 through September 2018.
An expanded recall of valsartan/amlodipine/hydrochlorothiazide, valsartan/amlodipine, and valsartan tablets by Torrent Pharmaceuticals Limited due to trace amounts of the impurity and probable human carcinogen N-nitrosodimethylamine. The recall now includes all lots of these unexpired products.
A class I recall of seven lots of the Tri-Flo Subglottic Suction System by Vyaire Medical, Inc., due to risk of device breakage. There is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs. The recall includes 2,150 units distributed from Jan. 23 to May 23, 2018.
A class I recall of replacement cushion seals for the Probasics Brand Zzz-Mask SG Full Face CPAP Mask by Compass Health due to possible air leaks. The mask is designed for patients who need continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea in the home. A design change to the cushion seal and accompanying elbow replacement parts could result in an air leak that interrupts therapy if used with the previous design of the mask. The recall includes 742 replacement cushion seals distributed from May 4, 2015, to Oct. 10, 2017.
A global market withdrawal of all versions of the CyPass Micro-Stent by Alcon due to safety concerns. The device was approved in 2016 to treat adults with glaucoma in conjunction with cataract surgery. The market withdrawal was based on data from a long-term safety study, which showed that patients who received the device had significantly more endothelial cell loss than patients who had cataract surgery alone.
Buprenorphine and naloxone sublingual film (Cassipa) for the maintenance treatment of opioid dependence. The approval provides a new dosage strength of buprenorphine and naloxone (16 mg/4 mg), which is also approved in generic and brand-name versions and in various strengths.
The PK Papyrus Covered Coronary Stent System to treat acute coronary artery perforations, which can occur during percutaneous coronary intervention (PCI). The device, the first approved for this indication in 17 years, received approval through the FDA's humanitarian device exemption process, as the condition affects 8,000 or fewer individuals in the U.S. each year. Survey data of 80 patients who received the stents showed that 95% had successful deliveries of the stents to the perforation site and that the device successfully sealed perforations in 91.3%. Two patients died during the PCI procedure, and seven patients were treated to drain fluid collection around the heart. Post-procedure, in-hospital death occurred in five patients whose perforations were sealed by the stents and in one patient whose perforation was not sealed. The system is contraindicated in patients who are not considered candidates for standard PCI procedures and in those with allergies or hypersensitivity to compounds of the stent.
First-time generic approvals
Ticagrelor tablets (60 mg and 90 mg) for post-acute coronary syndrome management. (Brand name: Brilinta)
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (200 mcg/50 mL and 400 mcg/100 mL [4 mcg/mL] single-dose containers) for sedation of non-intubated patients prior to and/or during surgical and other procedures. (Brand name: Precedex)
Cefepime for injection USP (100 g) to treat infections caused by susceptible strains of microorganisms. (Brand name: Maxipime)
Note: The FDA states that drugs are not always commercially available immediately after approval.