Recalls, warnings and label changes
A warning that methylphenidate medications (Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR) may in rare instances cause priapism. The warning has been added to the drug label and medication guide. Clinicians should talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. Priapism appears to be even more common in patients taking atomoxetine, so use caution when considering switching patients from methylphenidate to atomoxetine.
A recall of Vital Signs Devices' CO2 Multi Absorber Original due to a potential safety issue. The device may have a thin wall condition which may lead to small holes in the drain tube. This may result in a loss of anesthetic gases, ventilation and oxygenation.
A recall of 1 lot of Lidocaine HCl injection, USP, 2%, 5 ml in 5 ml vial by Hospira due to a reddish orange particulate on the inner surface and floating in the solution.
A recall of 2 lots of eculizumab (Soliris) concentrated solution for intravenous infusion by Alexion due to visible particles.
A recall of 1 lot of 5% dextrose injection, USP and 4 lots of 0.9% sodium chloride injection, USP by Baxter due to particulate matter found in the solutions.
A recall of 2 lots of Clinimix and 1 lot of Clinimix E injection parenteral nutrition products by Baxter due to complaints of particulate matter found in the products.
A recall of some TRUEbalance and TRUEtrack blood glucose meters by Nipro Diagnostics, Inc. because they may have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dl.
A warning about a specific dietary supplement, Mass Destruction, that has been linked to at least 1 reported serious illness. The product contains at least 1 synthetic anabolic steroid and led to a previously healthy 28-year-old male developing liver failure requiring transplant after several weeks of product use.
A recall of all sterile products dispensed by Abrams Royal Pharmacy due to concerns of lack of sterility assurance, after a single, isolated report of an adverse event involving a patient in California.
A warning about over-the-counter (OTC) sodium phosphate products because using more than 1 dose in 24 hours can cause rare but serious harm to the kidneys and heart, and even death. The FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes associated with use of the drugs to treat constipation. According to the reports, most cases of serious harm occurred with a single dose larger than recommended or with more than one dose in a day. Clinicians should use caution when recommending an oral dose of these products for children 5 and younger and the rectal form of these products should never be given to children younger than 2.
Label and packaging changes to over-the-counter topical antiseptic products for preoperative or preinjection skin preparation, due to reports of infections. The FDA is requesting that the products be packaged in single-use containers and labeled as either sterile or non-sterile. Clinicians should not dilute the products and should consider them as a possible source when investigating postoperative or postinjection infections.
A label change on regadenoson (Lexiscan) and adenosine (Adenoscan) regarding the rare but serious risk of heart attack and death. The label now recommends avoiding use of these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, and having cardiac resuscitation equipment and trained staff readily available before administering either drug.
A warning on clobazam (Onfi) about the risk of serious skin reactions. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) can occur at any time during treatment with clobazam, but the likelihood is greater during the first 8 weeks of treatment or when the drug is stopped and then re-started. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks or when re-introducing therapy. Clinicians should discontinue the drug at the first sign of rash.
A resumption of marketing for ponatinib (Iclusig) and new safety measures to address the risk of life-threatening blood clots and severe narrowing of blood vessels. The safety measures involve label changes to narrow the indication, provide additional warnings and precautions, revise recommendations about dosage and administration, and update the patient medication guide. A risk evaluation and mitigation strategy and postmarket investigations are also being required.
A recall of 20 lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips because they may produce erroneously low blood glucose results when used with the FreeStyle or FreeStyle Flash blood glucose meters (manufactured in 2010 or before) as well as the OmniPod insulin management system.
A recall of 1 lot of Baxter International Inc.'s nitroglycerin in 5% dextrose injection due to particulate matter found in 1 vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism or inflammation.
A recall of all lots of sterile products compounded by Nature's Pharmacy and Compounding Center (injectable drugs and eye drops, distributed in North Carolina) due to sterility assurance concerns during a recent FDA inspection.
A recall of Hospira's GemStar infusion system because the proximal and distal pressure sensor calibration can drift. A pump with this issue may shut down, not detect occlusions or issue false occlusion alarms. Potential risks include a delay or interruption in therapy or over-infusion.
A recall of Spacelabs Healthcare, Inc.'s anesthesia workstations and service kits because the bag-to-vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber, which could impede the ability to provide ventilation in bag mode.
Dapaglifozin (Farxiga) to treat type 2 diabetes, along with diet and exercise. Dapaglifozin is a sodium-glucose co-transporter 2 inhibitor. Safety and effectiveness were evaluated in 16 clinical trials of more than 9,400 patients, which showed improvement in hemoglobin A1c. It has been studied as a stand-alone therapy and in combination with other therapies including metformin, pioglitazone, glimepiride, sitagliptin and insulin. It should not be used to treat type 1 diabetes or patients with diabetic ketoacidosis, moderate or severe renal impairment or end-stage renal disease. The most common side effects are genital mycotic infections and urinary tract infections. An increased number of bladder cancers were diagnosed in patients on the drug so it is not recommended for patients with active bladder cancer. It can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. The FDA is requiring 6 post-marketing studies to assess cardiovascular, bladder cancer, liver and pregnancy risks, as well as use in pediatric patients.
Umeclidinium and vilanterol inhalation powder (Anoro Ellipta) for maintenance treatment of chronic obstructive pulmonary disease (COPD). The once-daily drug is a combination of umeclidinium, an inhaled anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). Safety and efficacy were evaluated in over 2,400 patients, showing it improved lung function compared to placebo. It carries a boxed warning that LABAs increase the risk of asthma-related death, and is not approved for the treatment of asthma. It may cause serious side effects, including paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma and worsening of urinary retention. The most common side effects are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain and chest pain.
The Cerena Transcranial Magnetic Stimulator (TMS) to treat migraine headaches preceded by aura. The first device approved to relieve pain from migraines, it is held against the back of the head. The user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain. In a trial of 113 migraine patients who used the device, nearly 38% of subjects were pain-free 2 hours later compared to about 17% of controls. After 24 hours, nearly 34% of the device users were pain-free compared to 10% of controls. The study did not show that the device is effective in relieving sensitivity to light, sensitivity to sound or nausea. Adverse events were rare but included single reports of sinusitis, aphasia and vertigo. Dizziness may be associated with the use of the device.
The AXIOS stent and delivery system for treating pancreatic pseudocysts. It is the first stent specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract. The stent and catheter are placed and then removed (after draining of the cyst) with endoscopic tools. A trial of 33 patients with pancreatic pseudocysts at least 6 centimeters in diameter found that 86% of the treated pseudocysts decreased in size by at least 50%. All stents were removed without injury to the surrounding tissue. Adverse events included abdominal pain, nausea and vomiting.
Coagulation Factor XIII A-subunit recombinant (Tretten) to treat congenital Factor XIII A-subunit deficiency. It is the first recombinant product approved for routine prevention of bleeding in adults and children with this disorder. It is a recombinant analogue of the human Factor XIII A-subunit, produced in yeast cells and then further purified. It is a sterile freeze-dried powder to be reconstituted with diluent and injected intravenously. In a study of 77 patients, it was effective in preventing bleeding in 90% when given monthly. Side effects include headache, pain in the extremities and pain at injection site.
The FDA is warning clinicians and the public that a nipple aspirate test is not a replacement for mammography, other breast imaging tests or breast biopsy. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition. Certain manufacturers are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, the agency said. The FDA is concerned that women will believe the misleading claims and not get mammograms and/or other needed breast imaging tests or biopsies.