Recalls, warnings, alerts
A class I recall of 469 automatic transport ventilators (models 01EVE700, 01EVE600 and 01EVE500) by O-Two Medical Technologies, Inc. due to potential risk of fire. An improperly inserted screw in the ventilator screen may wear through the electrical insulation, potentially creating a short circuit that could lead the device to catch fire and injure the patient. Recalled devices were distributed from July 2013 to November 2018.
An alert about the suspension of several clinical trials using the chemotherapy drug venetoclax in combination with other drugs to treat patients with multiple myeloma. There was an increased risk of death in patients taking the drug combination compared to the control group. The discontinued trials will not affect patients who are taking the drug for approved uses, which do not include multiple myeloma.
A safety communication about reports indicating that some people who use e-cigarettes (especially youth and young adults) are experiencing seizures following their use. From 2010 through early 2019, 35 cases of seizures following use of e-cigarettes were reported. The FDA is unsure if there is a direct relationship between the use of e-cigarettes and risk of seizure and believes the cases warrant scientific investigation.
A class I recall of Miller balloon and Fogarty dilation atrioseptostomy catheters by Edwards Lifesciences due to the possibility of difficulty in balloon deflation after deployment. The company has received reports of balloon fragmentation or detachment, including one serious injury in an infant. Recalled devices were distributed from Jan. 9, 2018, to Feb. 25, 2019.
A recall of two lots of the fentanyl transdermal system (12 µg/h transdermal patches) by Alvogen, Inc. due to incorrect labeling. Some cartons labeled 12 µg/h contained 50 µg/h patches, although individual 50 µg/h patches were correctly labeled.
A recall of 35 lots of bulk losartan potassium tablets USP (six lots of 25-mg strength; 29 lots of 100-mg strength) by Teva Pharmaceuticals USA, Inc., due to the detection of N-nitroso-N-methyl-4-aminobutyric acid (NMBA), a potentially cancer-causing impurity found in six lots of active pharmaceutical ingredient. The lots were sold exclusively to Golden State Medical Supply.
A recall of one lot of bevacizumab injection (1.25 mg/0.05 mL) by AmEx Pharmacy due to potential damage to the eye while the 31-gauge needle is in the eye. The product's syringe may become difficult to express and may cause injury to the patient when additional force is applied. The company has received three reports of such difficulty with the syringe, and two cases resulted in an adverse drug event.
A recall of 40 repackaged lots of losartan potassium tablets USP (25 mg, 50 mg, and 100 mg) by Legacy Pharmaceutical Packaging, LLC, due to the detection of trace amounts of NMBA.
An expanded recall by Torrent Pharmaceuticals Limited to include 36 additional lots of losartan potassium tablets USP and 68 lots of losartan potassium/hydrochlorothiazide tablets USP due to the detection of NMBA in the active pharmaceutical ingredient.
A warning that patients and families should not use unapproved medical devices (e.g., smartphone apps) to help assess or diagnose head injuries, including concussion and traumatic brain injury. These devices can result in an incorrect diagnosis and potentially put people in danger. All of the medical devices that have been cleared or approved by the FDA to aid in the diagnosis, treatment, or management of concussion require an evaluation by a health care professional.
First-time generic approvals
Naloxone hydrochloride nasal spray (4 mg/spray) for the emergency treatment of known or suspected opioid overdose. (Brand name: Narcan)
Ambrisentan tablets (5 mg, 10 mg) to treat pulmonary arterial hypertension. (Brand name: Letairis)
Bepotastine besilate ophthalmic solution (1.5%) to treat itching associated with signs and symptoms of allergic conjunctivitis. (Brand name: Bepreve)
Naftifine hydrochloride gel (1%) for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, and Epidermophyton floccosum. (Brand name: Naftin)
Aliskiren tablets (150 mg, 300 mg) to treat hypertension in adults. (Brand name: Tekturna)
Pyridostigmine bromide syrup (60 mg/5 mL) to improve muscle strength in patients with myasthenia gravis. (Brand name: Mestinon)
Fulvestrant injection (250 mg/5 mL [50 mg/mL]) to treat hormone-receptor-positive advanced breast cancer, or hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib, in postmenopausal women with disease progression following endocrine therapy. (Brand name: Faslodex)
Note: The FDA states that drugs are not always commercially available immediately after approval.