Recalls and warnings
A boxed warning added to febuxostat (Uloric) alerting clinicians and patients about an increased risk of death. The FDA approved febuxostat in 2009 to treat adults with gout. Based on a comprehensive review of results from a safety clinical trial, the agency has concluded that there is an increased risk of cardiovascular and all-cause mortality with the drug compared to allopurinol. Clinicians should reserve febuxostat for use only in patients who do not tolerate or have successful treatment with allopurinol. They should also counsel patients about the drug's cardiovascular risks and advise them to immediately seek medical attention if they experience symptoms such as chest pain, shortness of breath, or rapid or irregular heartbeat.
A class I recall of dual-chamber implantable pulse generators by Medtronic, Inc., due to the possibility of a software error that can result in a lack of pacing. The recall includes model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron (A, E, G, and Q series). The 13,440 devices were manufactured from March 2, 2017, to Dec. 18, 2018, and distributed in the U.S. from March 6, 2017, to Jan. 7, 2019.
A class I recall of certain models of LIFEPAK 15 monitor/defibrillators by Physio-Control, Inc., due to risk of device lockup after a shock is delivered. In the event of a freeze, the device cannot provide defibrillation therapy until it is reset. The resulting delay in shock delivery has resulted in serious patient injury, including death. The recall includes 8,164 devices manufactured and distributed nationwide from March 21, 2013, to July 18, 2016.
A class I recall of Swan-Ganz thermodilution catheters by Edwards Lifesciences due to incorrect assembly causing reversal of lumens, which may potentially result in inaccurate waveforms and pressure values. The recall includes 1,426 devices manufactured from Dec. 26, 2017, through April 19, 2018, and distributed nationwide from Jan. 20 to Aug. 20, 2018. Affected model numbers are 131F7, 131F7J, 131F7P, 131VF7P, and 151F7.
A recall of 87 lots of losartan tablets USP (25 mg, 50 mg, and 100 mg) by Camber Pharmaceuticals, Inc. due to the detection of an impurity. Trace amounts of N-nitroso-N-methyl-4-aminobutyric Acid (NMBA), a potential human carcinogen, were found in recalled products. This is the first recall of an angiotensin II receptor blocker (ARB) resulting from the presence of NMBA, the third type of nitrosamine impurity detected in these medicines. The two other impurities found in multiple generic ARBs are N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
An expanded recall of 38 lots of amlodipine/valsartan tablets USP (10 mg/160 mg) and valsartan tablets USP (40 mg, 80 mg, 160 mg, 320 mg) by Aurobindo Pharma USA, Inc., and Acetris Health, LLC, due to the detection of a nitrosamine impurity. Recalled products contain trace amounts of NDEA, a probable human carcinogen.
A recall of one lot of losartan potassium/hydrochlorothiazide combination tablets (100 mg/25 mg) by Macleods Pharmaceuticals Limited due to the detection of a nitrosamine impurity. Affected products contain trace amounts of NDEA.
An alert about an increased risk of pulmonary embolism and death with a particular dosing regimen of tofacitinib (Xeljanz, Xeljanz XR) in patients with rheumatoid arthritis. A safety trial found that patients with rheumatoid arthritis who received a 10-mg twice-daily dose of the drug had an increased occurrence of pulmonary embolism and death compared to those who received a 5-mg twice-daily dose or a tumor necrosis factor inhibitor. The 10-mg twice-daily dosing regimen is FDA-approved for patients with ulcerative colitis, but not for those with rheumatoid arthritis. Clinicians should follow the recommendations in the drug prescribing information for the specific condition they are treating.
A class I recall of certain lots of ChemoLock and ChemoClave Vial Spikes (20 mm) by ICU Medical, Inc., due to the potential for burr particulate to break off from the device's protective cap. Affected products were distributed nationwide between August 2018 and February 2019.
A safety communication alerting clinicians and patients that the safety and effectiveness of robotically assisted surgical devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer. To date, no robotically assisted surgical devices have been approved by the FDA based on cancer-related outcomes, such as overall survival, recurrence, and disease-free survival.
First-time generic approvals
Ingenol mebutate gel (0.05%, 0.015%) for the topical treatment of actinic keratosis. (Brand name: Picato Gel)
Sirolimus oral solution (1 mg/mL) for the prophylaxis of organ rejection in patients ages 13 years of age and older receiving renal transplants. (Brand name: Rapamune)
Note: The FDA states that drugs are not always commercially available immediately after approval.