A recall of ceftriaxone for injection USP by Lupin Pharmaceuticals, Inc., due to particulate matter. Recalled products (five lots of 250 mg, 10 lots of 500 mg, 24 lots of 1 g, and three lots of 2 g) have been found to contain visual gray particulate matter in reconstituted vials.
A class I recall of 1,200 disposable VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical, Inc., due to a risk of the devices being incorrectly assembled, which could result in a short circuit in the breathing hose and potentially lead to inadequate ventilation. Recalled devices were manufactured from January 2016 through November 2018 and distributed from April 2016 through December 2018.
A class I recall of Synergy and StealthStation S7 cranial software, which is used during neurosurgical procedures, due to reports of incorrect information displaying during biopsy procedures. The recall by Medtronic includes 5,487 products manufactured and distributed from Aug. 31, 2011, through Oct. 16, 2018.
A recall of one lot of irbesartan and seven lots of irbesartan hydrochlorothiazide tablets distributed by Solco Healthcare LLC due to the detection of N-Nitrosodiethylamine (NDEA) in the irbesartan manufactured by Zhejiang Huahai Pharmaceuticals. NDEA is a probable human carcinogen that should not be present in drug products, according to the FDA.
A recall of 80 lots of amlodipine valsartan tablets USP, valsartan hydrochlorothiazide tablets USP, and valsartan tablets USP by Aurobindo Pharma USA, Inc., due to the detection of NDEA in the finished drug product.
A recall expanded to six additional lots of losartan potassium and hydrochlorothiazide combination tablets by Torrent Pharmaceuticals Limited due to unacceptable amounts of NDEA in the losartan manufactured by Hetero Labs Limited. For the same reason, the company has also expanded its recall of losartan potassium tablets USP to a total of 10 lots.
A recall of three lots of vecuronium bromide for injection (10 mg) and one lot of vecuronium bromide for injection (20 mg) by Sun Pharmaceutical Industries, Inc., due to particulate matter identified as glass. Recalled products, which are used as an adjunct to general anesthesia, have an expiration date of March 2019.
A class I recall of Vial2Bag fluid transfer systems (13 mm and 20 mm) by West Pharmaceutical Services Inc. due to potential malfunctions. The systems are used to connect a vial containing medication to an intravenous therapy bag and to aid in mixing the medication with the fluid in the bag. The recall is due to the possibility that the device may not adequately transfer concentrated medication from a vial to a bag before infusion into a patient's vein, potentially leading to an overdose or underdose of medication. The FDA has received 16 complaints of serious adverse health consequences related to use of the 13-mm device with oxytocin in pregnant women in connection with labor and delivery. The recall includes 38.8 million units distributed nationwide from March 15, 2016, to Jan. 8, 2019.
A class I recall of certain lots of sterile saline and sterile water products by Smiths Medical due to potential exposure to infectious agents as a result of leaking containers used to package the finished products. While the initial recall was in September 2017, the FDA is auditing the recall to ensure that all affected products have been returned. The recall includes nearly 1 million products distributed from Aug. 30, 2013, to Feb. 10, 2017.
A recall of an additional lot of levetiracetam in 0.54% sodium chloride injection (1,500 mg/100 mL [15 mg/mL] in single-dose infusion bags) to the hospital level by Dr. Reddy's Laboratories Ltd. due to product mislabeling. The batch was distributed nationwide between Aug. 14, and Sept. 5, 2018.
Marketing of a new test to aid in the diagnosis of a sexually transmitted infection called Mycoplasma genitalium. The Aptima Mycoplasma genitalium assay is the first test authorized by the FDA to test for the M. genitalium bacterium, which is associated with nongonococcal urethritis in men and cervicitis and pelvic inflammatory disease in women. The bacterium grows slowly and is difficult to detect with traditional laboratory methods. The assay, a nucleic acid amplification test, detects the organism in urine, as well as in urethral, penile-meatal, endocervical, or vaginal swab samples collected in a clinical setting. In a study that included testing of 11,774 samples, the assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. While vaginal swabs are the preferred sample type in women, the test correctly detected the organism in female urine and endocervical samples 77.8% and 81.5% of the time, respectively. Overall, the test correctly identified samples that did not have M. genitalium present 97.8% to 99.6% of the time.
Trastuzumab-pkrb (Herzuma) and trastuzumab-dttb (Ontruzant) as biosimilars to trastuzumab (Herceptin). Both are approved to treat patients with HER2-overexpressing breast cancer, and trastuzumab-dttb is also approved to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. As for trastuzumab, the labeling contains a boxed warning alerting clinicians about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity. Common side effects include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious side effects include worsening of chemotherapy-induced neutropenia.
Tagraxofusp-erzs (Elzonris) infusion to treat blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients ages 2 years and older. The orphan drug is the first FDA-approved therapy for the blood and bone marrow disease. In a single-arm trial, seven (54%) of 13 patients with untreated disease achieved complete remission or complete remission with a skin abnormality not indicative of active disease. In a second cohort of 15 patients with relapsed or refractory disease, one patient achieved complete remission and one patient achieved complete remission with a skin abnormality not indicative of active disease. Common side effects were capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, chills, and weight increase. A boxed warning alerts clinicians about the increased risk of capillary leak syndrome, which may be life-threatening or fatal to patients in treatment.
Caplacizumab-yhdp injection (Cablivi), in combination with plasma exchange and immunosuppressive therapy, to treat adults with acquired thrombotic thrombocytopenic purpura. Efficacy of the drug was shown in a randomized, placebo-controlled trial of 145 patients, who all received the current standard of care (plasma exchange and immunosuppressive therapy) in addition to their assigned treatment. Compared to patients who received placebo, those treated with the orphan drug saw faster improvements in platelet counts and had better outcomes, such as a lower incidence of disease recurrence and disease-related death. Common side effects of the drug were headache and bleeding from the nose or gums. The medication's prescribing information warns patients and clinicians about the risk of severe bleeding.
Modifications to the Risk Evaluation and Mitigation Strategy (REMS) program for clozapine. A new series of requirements recently went into effect for the antipsychotic drug, which is used to help improve the symptoms of schizophrenia in patients who do not respond adequately to standard treatment. As part of the new requirements, prescribers and pharmacies must become certified in the clozapine REMS program by Feb. 28, 2019; otherwise, they are no longer able to prescribe and dispense the drug. Inpatient prescribers, however, are not required to be certified if they are prescribing for patients already enrolled in the program.
A letter to clinicians about treatment of peripheral arterial disease (PAD) with paclitaxel-coated balloons and paclitaxel-eluting stents. The FDA is evaluating recent information about the potential for increased long-term mortality after the use of these balloons and stents to treat PAD in the femoropopliteal artery, compared with the use of noncoated balloons or bare-metal stents. The agency recommends that clinicians discuss the risks and benefits of all available treatment options for PAD with patients and continue surveillance of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
A letter to clinicians regarding postapproval study results for the Abiomed Impella RP System, which was approved in September 2017 to provide temporary right ventricular support without open-chest surgery. The interim results suggest a higher mortality rate for patients treated with the system than the rate observed in premarket clinical studies. While the FDA is concerned about the high mortality rate, it maintains that the benefits of the system continue to outweigh the risks when used for the approved indication in appropriately selected patients.
A letter to clinicians about the association between all breast implants and breast implant-associated anaplastic large-cell lymphoma. The FDA has received reports indicating that patients with breast implants have an increased risk of developing the disease within the scar capsule adjacent to the implant. While most patients who have developed the disease had textured implants, there have been reports of patients with smooth-surfaced implants as well. To date, the FDA has received at least 660 reports of breast implant-associated anaplastic large-cell lymphoma. The agency recommends that clinicians be aware of the disease, particularly in patients with new swelling, lumps, or pain around breast implants, and report any cases to the FDA.
First-time generic approvals
Lurasidone hydrochloride tablets (20 mg, 40 mg, 60 mg, 80 mg, 120 mg) to treat depressive episodes associated with bipolar I disorder in adults. (Brand name: Latuda)
Toremifene citrate tablets (60 mg) to treat metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. (Brand name: Fareston)
Pimecrolimus cream (1%) as second-line therapy for short-term, noncontinuous chronic treatment of mild to moderate atopic dermatitis. (Brand name: Elidel)
Vigabatrin tablets USP (500 mg) to treat refractory complex partial seizures in patients ages 10 years and older who have responded inadequately to several alternative treatments. (Brand name: Sabril)
Hydroxyprogesterone caproate injection USP (1,250 mg/5 mL [250 mg/mL] in multi-dose vials) to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. (Brand name: Makena)
Methylphenidate hydrochloride extended-release capsules (10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg) to treat attention-deficit/hyperactivity disorder. (Brand name: Patesi XR)
Fluticasone propionate and salmeterol inhalation powder USP (100 µg/50 µg, 250 µg/50 µg, 500 µg/50 µg) to treat asthma in patients ages 4 years and older; the 250 µg/50 µg strength is also indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. (Brand name: Advair Diskus)
Note: The FDA states that drugs are not always commercially available immediately after approval.