Recalls continue for hypertension medicines

Recalls

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.

Approvals

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-dttb (Ontruzant), the third biosimilar to trastuzumab. The HER2/neu receptor antagonist is indicated to treat HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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.

Miscellaneous

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.

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)