Recalls and warnings
A new warning on proton-pump inhibitors (PPIs) about their association with Clostridium difficile-associated diarrhea (CDAD). A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve, and patients should be advised to seek immediate care if they experience watery stool that does not go away, abdominal pain and fever while taking PPIs. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
A recall of norgestrel and ethinyl estradiol tablets (14 lots generic and 14 lots of Lo/Ovral®-28) because some blister packs may contain an inexact count of inert or active-ingredient tablets and the tablets may be out of sequence. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect.
A class I recall of Respironics, Inc. Trilogy 100 Ventilators due to a manufacturing issue that can stop delivery of therapy. Part of the blower may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.
A boxed warning and new contraindication on brentuximab vedotin (Adcetris) after two additional cases of progressive multifocal leukoencephalopathy (PML) developed in patients taking the drug. The new contraindication advises against use of Adcetris with bleomycin due to increased risk of pulmonary toxicity.
Additional information about the risk of PML in patients taking natalizumab (Tysabri). Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor. A patient's antibody status may be determined using an anti-JCV antibody detection test. The risks and benefits of continuing treatment with natalizumab should be carefully considered in patients who are found to be positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of 11/1,000 users.
A recall of one lot of bendamustine HCL (Treanda) for injection 25 mg/8 mL due to particulate matter found in a single vial, which has been identified as glass fragments.
A warning about drug interactions between boceprevir (Victrelis) and ritonavir-boosted HIV protease inhibitor drugs. A drug interaction study showed that taking boceprevir with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with lopinavir/ritonavir (Kaletra), reduced the blood levels of the HIV medicines and boceprevir in the body. Patients who are on this combination should be closely monitored for hepatitis C virus (HCV) treatment response and for potential HCV and HIV virologic rebound.
A class Irecall of Salter Labs 7600 Bubble Humidifier due to a manufacturing defect that causes the humidifier lids to fail to pop off at the intended pressure, which can lead to a leak. A humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop, resulting in death or serious adverse health consequences.
A warning about counterfeit bevacizumab (Avastin) which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, claims to be manufactured by Roche and does not contain the medicine's active ingredient. It was sold by Quality Specialty Products, a foreign supplier that may also be known as Montana Health Care Solutions.
A health advisory about Gris-PEG (griseofulvin ultramicrosize) 125 mg and 250 mg because an error in the manufacturing process may have caused tablets from one product to be placed in the bottle of another.
Glucarpidase (Voraxaze) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. The drug is an intravenously administered enzyme that rapidly reduces methotrexate levels by breaking it down to a form that can be eliminated from the body. The orphan drug was approved based on a study of 22 patients, in which it eliminated 95% of methotrexate overall.