Recalls and warnings
A recall of two lots of topiramate (Topamax) 100-mg tablets due to reports of an uncharacteristic odor, thought to be caused by a chemical in wooden pallets used to transport the drug.
A safety alert about continuing reports of hepatosplenic T-cell lymphoma in adolescents and young adults being treated with tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. The majority of cases were in patients being treated for Crohn's disease or ulcerative colitis, but a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis were also affected. Clinicians should monitor at-risk patients for the emergence of malignancies and educate patients and families about signs and symptoms, which may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats and weight loss.
A new requirement that all extended-release and long-acting opioid medications carry a Risk Evaluation and Mitigation Strategy, which will focus on educating doctors about proper pain management, patient selection and other requirements, and improving patient awareness about how to use the drugs safely. The changes are expected to become effective by early 2012 and will be required for drugs including hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl and transdermal buprenorphine.
A label change on natalizumab (Tysabri) about the risk of progressive multifocal leukoencephalopathy (PML). The label now warns that patients who take an immune-suppressing medication (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate) prior to natalizumab are at increased risk for PML. The label also now contains a table summarizing the rates of PML associated with different numbers of infusions.
A recall of one lot of American Regent's ammonium molybdate injection, 10- mL single-dose vials, because some vials of this lot were observed to contain particulates. Potential adverse events may include disruption of blood flow within small blood vessels in the lungs, localized inflammation and granuloma formation.
A recall of one lot of 1,000-count bottles of warfarin sodium (Coumadin) 5-mg tablets because a single tablet was found to be higher in potency than expected. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities.
A recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names due to a software problem that in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy, which may result in failure to resuscitate the patient.
A recall of the Axxent FlexiShield Mini, Model 5300, because it may shed particles of tungsten. If the device is used during intraoperative radiation therapy for breast cancer, these particles can be mistaken for suspicious calcifications during follow-up X-rays or scans.
A class I recall of the Penumbra Coil 400 system because the pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. This may cause the coil to unintentionally migrate, potentially leading to serious injury including blood clots and stroke.
A new indication for rituximab (Rituxan) to treat Wegener's granulomatosis and microscopic polyangiitis, two rare disorders that cause vasculitis. Used in combination with glucocorticoids, the drug induced remission in more patients than did cyclophosphamide. It carries boxed warnings about infusion reactions, severe mucocutaneous reactions and PML.
A new indication for the meningococcal vaccine Menactra, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children as young as 9 months. The vaccine is already approved for use in people ages 2 through 55 years. Expanded approval was based on a study of 3,700 in which the most common adverse events were injection-site tenderness and irritability.
Abiraterone acetate (Zytiga) to treat metastatic, castration-resistant prostate cancer in patients who have received prior docetaxel. The drug, a pill that's used in combination with prednisone, decreases production of protein CYP17A1 and lengthened survival from 10.9 months on placebo to 14.8 months. It was approved under the FDA's priority review program.
Linagliptin (Tradjenta) tablets to treat type 2 diabetes, along with diet and exercise. The drug blocks the enzyme dipeptidyl peptidase-4 or DPP-4, leading to better blood glucose control, and was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients. It has been studied as a stand-alone therapy and in combination with other therapies including metformin, glimepiride, and pioglitazone, but not in combination with insulin. It should not be used to treat people with type 1 diabetes or diabetic ketoacidosis.
The cPAX Aneurysm Treatment System, a device for surgery on large brain aneurysms that are difficult to manage because of their size and shape. It was approved under a Humanitarian Device Exemption for treatments affecting patients with rare medical conditions, based on safety data from two studies of 43 subjects.
A new indication for tocilizumab (Actemra), to treat active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older, either alone or in combination with methotrexate. Tocilizumab is an interleukin-6 receptor blocker approved last year for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to other approved therapies. In an 112-patient trial, 85% responded to tocilizumab, compared to 24% on placebo. The drug carries a boxed warning for serious infections.
The FDA has received reports that lansoprazole delayed-release orally disintegrating tablets have clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices. The tablets may not fully disintegrate when water is added to them and/or they may disintegrate but later form clumps, which can adhere to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced. The FDA recommends not dispensing the tablets when they will be administered through an oral syringe or feeding tube and instructing patients and caregivers not to administer the tablets through oral syringes and/or feeding tubes.
The FDA is requiring manufacturers of long-acting beta-agonists (LABAs) to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone, in order to establish the safety of combined treatment.