Recalls and warnings
A class I recall of 15,714 AirLife Resuscitation Devices by Vyaire Medical, Inc., due to a manufacturing error preventing oxygen delivery. Extra plastic material in the oxygen output connection may reduce or block the flow of oxygen to the patient. Affected devices were distributed from Feb. 2 to April 20, 2018.
A recall of two lots of piperacillin and tazobactam for injection USP (3.375 g single-dose vials) by AuroMedics Pharma LLC due to presence of particulate matter. A vial from one lot was found to contain glass, and a vial from the second lot was found to contain silicone material. One lot was shipped on June 30, 2017, and the other was shipped between Nov. 27, 2017, and Jan. 29, 2018.
A class I recall of 253 units of the Arkon Anesthesia Delivery System by Spacelabs Healthcare due to the system entering a failed state and ceasing mechanical ventilation while the machine is in use or idle. Affected units were distributed between Oct. 1, 2012, and Oct. 6, 2017.
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. The database is available online.
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 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.
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)
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)
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)
Dextrose injection (10%) to treat hypoglycemia. (Brand name: Dextrose Injection USP)
Note: The FDA states that drugs are not always commercially available immediately after approval.