Recalls, warnings and label changes
A recall by Med Prep Consulting of all lots of all products compounded at its facility due to a report of visible mold in five bags of magnesium sulfate provided to one hospital.
A recall by Clinical Specialties of all sterile products repackaged and distributed by the pharmacy due to visible mold, after five reports of serious eye infections associated with Avastin unit dose syringes from the pharmacy.
A recall by Pallimed Solutions, Inc., of all sterile compounded products due to observation of visible mold in vials of sterile products during a recent FDA inspection.
A class I recall of Symbios GOPump Elastomeric Infusion PumpKit because the flow restrictor bead may become displaced from its fitting, which may permit solutions to flow at a higher rate than intended.
A nationwide recall of specific lots of Guardian II and Guardian II NC hemostasis valves, because they pose a slightly increased risk of air leakage that may lead to an air embolism.
A class I recall of CAS I/II Absorbers in the Spacelabs anesthesia workstations and service kits due to a flaw that may lead to an increase in the carbon dioxide concentration of the inhaled gas being delivered to the patient.
A recall of one lot of 0.9% sodium chloride injection, USP, 1000 mL, by Hospira, due to one confirmed customer report of brass particulates in the primary container.
A safety alert, related to the previous recall of Neptune 1 Silver and 2 Ultra waste management systems, reminding clinicians that anyone still using the device must be properly trained, aware of the risks associated with the device, and implementing the Neptune Pre-use Checklist.
A notification of incomplete foil seals on certain lots of MTS Anti-IgG and A/B/D monoclonal and reverse grouping cards.
A class I recall of BCI remote alarm cables because they are not transferring alarm signals from the Capnocheck capnography system when used with some remote nurse alarm systems.
A recall of one lot of BIVIGAM immune globulin intravenous (human), 10% liquid, 100-mL sterile vials, due to observation of visible particles during an inspection.
A class I recall of Animas Corporation 2020 insulin infusion pumps because a component issue may trigger the pumps to sound a false alarm or warning that can lead to unintended delivery of insulin. The pump also has a software limitation that will impact the ability of the pump to function past Dec. 31, 2015.
A new warning on azithromycin (Zithromax or Zmax) about abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients are at particular risk if they have existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat arrhythmias. Clinicians should consider the risk of torsades de pointes and fatal heart rhythms when choosing treatments for patients who are already at risk for cardiovascular events, but recall that alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects.
A recall of all lots of peginesatide (Omontys) injection due to postmarketing reports of serious hypersensitivity reactions, including anaphylaxis. Fatal reactions have been reported in approximately 0.02% of patients following the first intravenous dose, and all serious hypersensitivity reactions occurred within 30 minutes of administration.
A class I recall of the St. Jude Medical Amplatzer TorqVue FX Delivery System because the distal end of the core wire could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
A recall of one lot of cidofovir (Vistide) injection due to the presence of particulate matter in some vials. Before injecting the drug, clinicians should inspect the product and any product with lot number B120217A should not be injected.
A class I recall of certain models of Lumenis VersaCut Tissue Morcellator due to potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This may cause serious adverse health consequences, including death.
A class I recall of Ad-Tech Macro Micro Subdural Electrodes because the microelectrodes may be defective. There is the potential for abrasion of brain tissue and for broken pieces to remain in the brain tissue when the electrode is removed. This may lead to hemorrhaging or a seizure, as well as death. One serious injury has been reported.
Canaglifozin (Invokana) tablets, to improve glycemic control in adults with type 2 diabetes, along with diet and exercise. The drug is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved. Safety and effectiveness were evaluated in nine clinical trials of over 10,000 patients, which showed improvements in hemoglobin A1c and fasting plasma glucose. The drug has been studied as a stand-alone therapy and in combination with metformin, sulfonylureas, pioglitazone and insulin. It should not be used in patients with type 1 diabetes, diabetic ketoacidosis, severe renal impairment or end-stage renal disease. The FDA is requiring five postmarketing studies: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies. Common side effects were candidiasis and urinary tract infection.
Tobramycin inhalation powder (TOBI Podhaler) for the management of cystic fibrosis patients with Pseudomonas aeruginosa. The plastic, handheld inhaler device contains a dry-powder formulation of tobramycin that is inhaled twice daily for 28 days. Patients should then stop the therapy for 28 days before resuming again. Effectiveness was established in a study of 95 pediatric and adult patients in which treated patients experienced a statistically significant increase of 12.5% in forced expiratory volume in one second compared to 0.09% on placebo. Common side effects included cough, hemoptysis, lung disorder, shortness of breath, fever, mouth and throat pain, dysphonia and headache.
Dimethyl fumarate capsules (Tecfidera) to treat adults with relapsing forms of multiple sclerosis. Two clinical trials showed patients on the drug had fewer relapses compared to those on placebo, and one showed an association with less worsening of disability. The drug may decrease lymphocyte counts, so patients' lymphocyte count should be assessed before starting treatment and annually thereafter. Flushing and stomach problems were the most common adverse reactions.
Doxylamine succinate and pyridoxine hydrochloride (Diclegis) for pregnant women experiencing nausea and vomiting. The delayed-release tablet, taken whole on an empty stomach, is intended for women who have not adequately responded to conservative management, such as dietary and lifestyle modifications. Studies have shown that the drug reduces nausea and vomiting more effectively than placebo and does not cause harm to the fetus. The most common side effect was sleepiness. The drug was previously sold as Bendectin and was pulled from the market due to concerns about birth defects.
Ospemifene (Osphena) to treat women experiencing moderate to severe dyspareunia. A pill taken with food once daily, it acts like estrogen to make vaginal tissues thicker and less fragile. Safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women. After 12 weeks of treatment, women had statistically significant improvement of dyspareunia with the drug compared to placebo. The drug carries a boxed warning about the risk of endometrium thickening and the incidence rates of thrombotic and hemorrhagic strokes and deep vein thrombosis (0.72, 1.45 and 1.45 per thousand women, respectively). It should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
Ado-trastuzumab emtansine (Kadcyla) to treat HER2-positive, metastatic breast cancer. The drug is intended for patients who were treated with trastuzumab and taxanes before. Safety and effectiveness were evaluated in a study of 991 patients randomized to ado-trastuzumab emtansine (median progression-free survival of 9.6 months) or lapatinib plus capecitabine (6.4 months). The drug is approved with a boxed warning about liver toxicity, heart toxicity and death.
Regorafenib (Stivarga) to treat advanced gastrointestinal stromal tumors that cannot be surgically removed and that no longer respond to other FDA-approved treatments for this disease. Safety and effectiveness were evaluated in study of 199 patients in which patients taking the drug had 3.9 months more progression-free survival than patients who were given placebo. The drug was approved to treat colorectal cancer in September 2012.
Technetium Tc 99m tilmanocept (Lymphoseek) injection, a radioactive diagnostic imaging agent to locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. It is the first drug approved for lymph node mapping in more than 30 years. Safety and effectiveness were established in two trials of 332 patients, in which Lymphoseek and blue dye localized most lymph nodes, but a notable number were localized only by Lymphoseek.
The Argus II Retinal Prosthesis System, the first implanted device to treat advanced retinitis pigmentosa. The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit and an implanted retinal prosthesis, replaces the function of degenerated cells in the retina and may improve a patient's ability to perceive images and movement. Of 30 patients who received the device in a trial, most were better able to perform basic activities and 19 experienced no adverse events. Eleven study subjects experienced a total of 23 serious adverse events, including retinal detachment, inflammation, and hypotony.
A new silicone breast implant, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, for augmentation in women at least 22 years old and reconstruction in women of any age. Approval was based on seven years of data from 941 women, which showed complications and outcomes similar to previous breast implant studies, including capsular contracture, re-operation, implant removal, asymmetry and infection.