Recalls, warnings, and alerts
A warning about an increased risk of heart problems or death in patients with heart disease who take clarithromycin (Biaxin). Clinicians should consider prescribing other antibiotics to these patients, the FDA recommended. The agency based its recommendation on results from a 10-year follow-up of a large clinical trial of patients with coronary heart disease, which first observed the safety issue after one year of follow-up.
A global market withdrawal of the multiple sclerosis drug daclizumab (Zinbryta) amid concerns about the drug's benefit-to-risk profile. Worldwide, there have been 12 reports of serious inflammatory brain disorders in patients using the drug. The FDA is working with manufacturers to ensure that clinicians have the information they need to safely transition patients on the drug to another treatment.
A recall of three lots of hydromorphone hydrochloride injection USP (10 mg/mL, 1 mL in 2 mL single-dose vials) by Hospira due to the potential for vials to be empty or cracked. Affected products were distributed nationwide from October 2016 to July 2017. The manufacturer also recalled three lots of labetalol hydrochloride injection USP (100 mg/20 mL vial) and one lot of labetalol hydrochloride injection USP (Novaplus) after discovering cracked vials. Affected products were distributed nationwide from April to August 2017.
A class I recall of 48 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy with defibrillation (CRT-D) devices by Medtronic due to a manufacturing error. The defect may prevent the devices from delivering electrical shock therapy, resulting in serious patient injury or death. Recalled devices were manufactured between July 13, 2013, and Aug. 8, 2017.
A warning not to use drug products from Cantrell Drug Company, including opioids and other drugs intended for sterile injection. The FDA is concerned about the company's compounding operations and its ability to ensure quality and sterility assurance and has sought legal action to prevent it from producing and distributing additional drugs.
A recall of 10 lots of methylprednisolone sodium succinate for injection USP (40 mg, 125 mg, and 1 g) due to high out-of-specification impurity results. Recalled products were distributed by Sagent Pharmaceuticals, Inc. from April 2017 to February 2018.
A warning to all three duodenoscope manufacturers for failing to fulfill requirements to conduct studies assessing the real-world effectiveness of device reprocessing. If the companies fail to properly respond to the warning letter, the FDA may take additional punitive action.
Recall and destruction of a large number of kratom-containing dietary supplements. Affected products were manufactured and distributed nationwide by Divinity Products Distribution under the brand names Botany Bay, Enhance Your Life, and Divinity. The FDA maintains that there is no evidence indicating that the plant is safe or effective for any medical use. In addition, the FDA and CDC are monitoring a Salmonella outbreak associated with kratom products that has spanned 20 states.
Ibalizumab-uiyk (Trogarzo) to treat adults with HIV who are heavily treatment-experienced but whose HIV infections cannot be successfully treated with currently available therapies. The orphan drug is given intravenously by a trained medical professional once every 14 days and is used in combination with other antiretrovirals.
Expanded approval of durvalumab (Imfinzi) to treat patients with stage III non-small cell lung cancer with unresectable tumors whose cancer has not progressed after chemoradiation. The drug was previously approved to treat certain patients with locally advanced or metastatic bladder cancer.
Authorization of the first direct-to-consumer test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi Jewish descent. The Personal Genome Service Genetic Health Risk Report analyzes DNA from a self-collected saliva sample. The test only detects three out of more than 1,000 known BRCA mutations, so a negative result does not rule out increased cancer risk.
Expanded approval of brentuximab vedotin (Adcetris) to treat adults with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. The drug was previously approved to treat classical Hodgkin lymphoma after relapse and after stem cell transplant for patients at high risk of relapse or progression, as well as to treat systemic and primary cutaneous anaplastic large cell lymphoma after other treatment failure.
First-time generic approvals
Cinacalcet hydrochloride tablets (30 mg [base], 60 mg [base], and 90 mg [base]) to treat secondary hyperparathyroidism in adults with chronic kidney disease on dialysis; hypercalcemia in adults with parathyroid carcinoma; and severe hypercalcemia in adults with primary hyperparathyroidism who are unable to have parathyroidectomy. (Brand name: Sensipar)
Desflurane USP (liquid for inhalation) for general anesthesia. (Brand name: Suprane)
Sumatriptan and naproxen tablets (85 mg/500 mg) to treat adults with acute migraine, with or without aura. (Brand name: Treximet)
Trientine hydrochloride capsules USP (250 mg) to treat patients with Wilson's disease when continued treatment with penicillamine is not possible due to intolerable or life-threatening side effects. (Brand name: Syprine)
Note: The FDA states that drugs are not always commercially available immediately after approval.