Recalls and warnings
A recall of additional valsartan-containing products. New recalls have been initiated by Torrent Pharmaceuticals Limited and Camber Pharmaceuticals. The companies join several others that have recalled affected products because they may contain the impurity N-nitrosodimethylamine, a probable human carcinogen.
A warning that azithromycin (Zithromax, Zmax) should not be given long-term to prevent bronchiolitis obliterans syndrome after donor stem-cell transplant in patients with cancers of the blood or lymph nodes. A clinical trial found an increased rate of cancer relapse and death in these patients. The FDA is reviewing additional data before making further recommendations.
An extension of the expiration date of specific lots of epinephrine auto-injectors (EpiPen, 0.3 mg) to mitigate shortages of the product. Affected products have already been dispensed to patients and will have their 20-month shelf life extended by four months. The change is based on stability data provided by Mylan, which markets the product.
A new FDA medication guide database. In August 2018, the FDA launched an updated medication guide database to replace the former website. Features of the new database include search capabilities by active ingredient and brand name, improved usability on mobile devices, download capabilities to spreadsheets, and streamlined data entry for faster updates.
A segesterone acetate and ethinyl estradiol vaginal system (Annovera) to prevent pregnancy. The contraceptive is the first vaginal ring that can be used for an entire year. The reusable ring is placed in the vagina for three weeks, followed by one week out of the vagina (when it is washed and stored in a compact case), at which time a women may experience withdrawal bleeding. The results of three open-label trials of women ages 18 to 40 years determined that two to four out of 100 women who use the ring may get pregnant in the first year of use. A boxed warning cautions users about cigarette smoking and serious cardiovascular events. Common side effects are similar to other combined hormonal contraceptives and include headache, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.
Marketing of the first mobile medical app that can be used as a contraception method in premenopausal adult women. The app, called Natural Cycles, uses an algorithm to calculate the days of the month a woman is likely to be fertile, based on menstrual cycle information and daily readings from a basal body thermometer. On fertile days, the app instructs users to use protection or abstain from sex. Clinical studies of 15,570 women showed the app had a failure rate of 1.8% with perfect use and 6.5% with typical use.
Marketing of the Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder (OCD). Marketing of transcranial magnetic stimulation has also been approved to treat major depression and pain associated with certain migraine headaches. In a randomized study of 100 patients with OCD, 38% of patients who used the device had a 30% or more reduction in Yale-Brown Obsessive Compulsive Scale scores, compared to 11% of those who used a sham device. The most frequent adverse reaction was headache, reported by about 35% of patients in both treatment groups. The device is contraindicated in patients who have metallic objects or implanted stimulator devices in or near the head.
Patisiran (Onpattro) infusion to treat adults with peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis. The drug, which is part of a new class of drugs called small interfering ribonucleic acid, is the first FDA-approved treatment for the rare, often fatal genetic disease. In a randomized trial of 225 patients, those who received the drug once every three weeks for 18 months had better outcomes on measures of polyneuropathy than those receiving placebo infusions. The most common adverse reactions include flushing, back pain, nausea, abdominal pain, dyspnea, and headache.
Iobenguane I 131 (Azedra) intravenous injection to treat patients ages 12 and older with unresectable pheochromocytomas that have spread beyond the original tumor site and require systemic anticancer therapy. The drug is the first to be approved by the FDA to treat the rare adrenal tumors. In a single-arm trial of 68 patients, 25% had a 50% or greater reduction of all antihypertensive medication for at least six months, and 22% achieved an overall tumor response. The most common severe side effects were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting. The drug is radioactive and includes a warning about minimizing radiation exposure to patients and family members during treatment.
Migalastat (Galafold), the first oral medication to treat adults with Fabry disease. The drug is indicated for adults with the disease who have a genetic mutation determined to be amenable to treatment with the orphan drug, based on laboratory data. In one study of 45 adults, those treated with the drug over six months had a greater reduction in globotriaosylceramide in blood vessels of the kidneys compared to patients who received placebo. The most common adverse drug reactions in clinical trials were headache, nasopharyngitis, urinary tract infection, nausea, and fever.
First-time generic approvals
Epinephrine injection USP (0.15 mg and 0.3 mg) for emergency treatment of allergic reactions, including anaphylaxis. (Brand name: EpiPen, EpiPen Jr)
Epinephrine injection (1 mg/mL) for emergency treatment of allergic reactions, including anaphylaxis. (Brand name: Adrenalin)
Cetirizine hydrochloride capsules (10 mg) for temporary relief of runny nose, itchy and watery eyes, sneezing, and itching of the nose or throat due to hay fever or other respiratory allergies. (Brand name: Cetirizine Hydrochloride Capsules)
Roflumilast tablets (500 mcg) to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (Brand name: Daliresp)
Emtricitabine capsules (200 mg) to treat HIV-1 infection in combination with other antiretroviral agents. (Brand name: Emtriva)
Morphine sulfate injection USP (200 mg/20 mL [10 mg/mL] and 500 mg/20 mL [25 mg/mL] single-use vials) to manage severe pain when alternative treatments are not expected to be adequate and for the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. (Brand name: Infumorph)
Dorzolamide hydrochloride and timolol maleate ophthalmic solution (2%/0.5% PF) to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. (Brand name: Cosopt)
Teriflunomide tablets (7 mg and 14 mg) to treat patients with relapsing forms of multiple sclerosis. (Brand name: Aubagio)
Asenapine sublingual tablets (5 mg and 10 mg) to treat adults with bipolar I disorder as an adjunctive treatment to lithium or valproate. (Brand name: Saphris)
Temsirolimus injection (25 mg/mL single-dose vials) to treat advanced renal-cell carcinoma. (Brand name: Torisel)
Indium in 111 oxyquinoline solution USP (1 mCi/mL) for radiolabeling autologous leukocytes. (Brand name: Indium in 111 Oxyquinoline Solution)
Dextrose injection (10%) to treat hypoglycemia. (Brand name: Dextrose Injection USP)
Hydroxyprogesterone caproate injection USP (250 mg/mL single-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)
Note: The FDA states that drugs are not always commercially available immediately after approval.