HbA1c test approved for diagnosing diabetes, more compounded products recalled

Details on recalls, warnings and approvals.


Recalls and warnings

A recommendation not to use magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women because it may lead to low calcium levels and bone problems in the fetus, including osteopenia and fractures. This use of the drug is off label. The shortest duration of treatment that can result in harm to the baby is not known.

Photo by Thinkstock
Photo by Thinkstock.

A recall of one lot of Fresenius Kabi USA magnesium sulfate injection, 500 mg/mL strength in 50-mL glass vials, due to the potential presence of glass particles in the vials, which could lead to thromboembolism, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets and subsequent generation of microthrombi.

A recall of two lots of Sandoz US methotrexate sodium injectable, 25 mg/mL strength in 40-mL vials, due to the discovery of particulate matter in vials during routine quality examination.

A recall of all lots of vecuronium bromide for injection, 10 mg, manufactured by Mustafa Nevzat Ilac Sanayii A.S. and distributed by Sagent Pharmaceuticals, due to the discovery of an elevated impurity result during routine quality testing.

A recall of all sterile products compounded by the Main Street Family Pharmacy in Tennessee due to reported cases of skin abscesses, one of which appears to be fungal, and bacterial and fungal growth in samples from two unopened vials of preservative-free methylprednisolone acetate.

A recall of all sterile products compounded by Lowlite Investments, Inc. d/b/a Olympia Pharmacy due to concerns associated with prior quality control procedures that impacted sterility assurance.

A recall by Pentec Health of nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding.

A recall of one lot of Zydus Pharmaceuticals USA Inc. warfarin 2-mg tablets because four tablets have been found to be oversized in one product complaint. Ingestion of a greater-than-intended dose could cause patients to develop bleeding as an adverse reaction.

A recall of Symbios Medical Products' GoPump rapid recovery system kits and GOBlock kits because these products have been found to potentially cause excessively high flow rates, which present a risk of patient toxicity and serious injury, particularly in patients with low body mass or advanced age.

A recall of Cook Medical, Inc. Zilver PTX drug- eluting peripheral stents due to complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events include surgery to remove the catheter tip, vascular occlusion, thrombosis, amputation, cardiac arrest, and death.

A recall of Nephron Pharmaceuticals Corp. EZ Breathe atomizer due to a manufacturing defect which could result in the washer becoming dislodged. If this occurs, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death.

A class I recall of Cardinal Health's Presource Kits containing a pre-assembled anesthesia circuit and filter because of outer plastic packaging on one or more components. If the packaging is removed without dissembling the components, remnants of the plastic may become lodged in the filter, potentially causing an obstruction in airflow. This may result in serious adverse health consequences including hypoxia, suffocation and death.

A warning that one lot of Covidien Endo GIA Articulating 60-3.5 surgical stapler reloads were stolen from the manufacturer before they were sterilized. Some of these stolen and unsterile products have been offered for sale. The use of these non-sterile products could increase the risk of infection in surgical patients.

A class I recall of Medtronic Deep Brain Stimulation Lead and Activa Dystonia HDE kits due to the use of the lead cap provided. Leads have been damaged at the connector end of the lead when the lead cap is used. Lead replacement may be required or optimal therapy may not be provided.

A class I recall of Maquet SERVO-i ventilator battery modules because some have been found to have a shorter battery run time than expected. This can result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death.

A class I recall of ShapeMatch cutting guides due to one software defect that results in wider cutting ranges and another that results in displayed parameters not matching the cutting guides. This may result in serious adverse health consequences, including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.

Approvals

The first hemoglobin A1c test specifically labeled for diagnosing diabetes (COBAS INTEGRA 800 Tina-quant HbA1cDx assay). Many clinicians have already been using HbA1c tests to diagnose diabetes, but they were not specifically designed or approved for this use, making it difficult to know which tests were sufficiently accurate. In support of marketing clearance for the new assay, investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the new test compared to the standard reference for hemoglobin analysis.

Radium Ra 223 dichloride (Xofigo) to treat men with symptomatic metastatic castration-resistant prostate cancer that has spread to the bones but not to other organs. Safety and effectiveness were evaluated in a single clinical trial of 809 men, in which a pre-planned interim analysis showed men receiving the drug lived a median of 14 months compared to a median of 11.2 months on placebo. The most common side effects were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

A new indication for golimumab (Simponi) injection to treat adults with moderate to severe ulcerative colitis that is refractory to prior treatment or requires continuous steroid therapy. Safety and effectiveness for treating ulcerative colitis were established in two clinical studies: one in which more treated patients achieved clinical response or clinical remission after six weeks compared with placebo and another in which responding patients maintained clinical response through week 54. The drug was previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The most common side effects are upper respiratory infection and redness at the injection site. Patients are at increased risk of developing serious infections, heart failure, nervous system disorders and allergic reactions.

Dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with metastatic or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients whose tumors express the BRAF V600E gene mutation. Trametinib, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K mutations. The drugs were approved with a genetic test called the THxID BRAF test, a companion diagnostic that will help determine if a patient's melanoma cells have the mutations. In trials, patients who took the drugs had a delay in tumor growth of 2-3 months compared to those on chemotherapy. The most serious side effects with dabrafenib included an increased risk of cutaneous squamous cell carcinoma, fevers that may be complicated by hypotension, severe rigors, dehydration, kidney failure and increased blood sugar levels. The most serious side effects with trametinib included heart failure, lung inflammation, skin infections and loss of vision.

A new indication for denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone (GCTB) when the tumor is unresectable or surgery is likely to result in severe morbidity. Safety and effectiveness for GCTB were established in two clinical trials of 305 adult or adolescent patients. Of the 187 patients whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Common side effects included arthralgia, headache, nausea, fatigue, back pain and extremity pain. The most common serious side effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive age should use highly effective contraception while taking the drug because of potential fetal harm. Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones.

An alternative to plasma (prothrombin complex concentrate, human; brand name, Kcentra) for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly, and it is administered in significantly lower volume than plasma. Kcentra is associated with the occurrence of blood clots when used as indicated and carries a boxed warning regarding this risk. The warning also explains that patients should be monitored for signs and symptoms of thromboembolic events. Kcentra is made from the pooled plasma of healthy donors, and approval was based on a study of 216 patients in which it was demonstrated to be similar to plasma in its ability to stop acute major bleeding.

Combined fluticasone furoate and vilanterol inhalation powder (Breo Ellipta) for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD. Safety and efficacy were evaluated in a study of 7,700 patients in which those treated showed improved lung function and reduced exacerbations compared to placebo. The once-daily drug carries a boxed warning that long-acting beta2-adrenergic agonists increase the risk of asthma-related death. The drug may cause serious side effects, including pneumonia and bone fractures. The most common side effects include nasopharyngitis, upper respiratory tract infection, headache and thrush.

Miscellaneous

Injectable drugs used in total parenteral nutrition (TPN) that are in critical shortage will be imported into the United States, the FDA recently announced. The FDA is exercising regulatory discretion to allow Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norwegian plant. The shortages are largely the result of a decision by American Regent/Luitpold to temporarily shut down at the end of 2012 to address quality issues that included particulate matter in its injectable products.