Recalls, label changes, safety reviews
A recall of several devices made by Hospira, Inc. for defective AC power cords because reports were received of sparking, charring and fires on the plug of the power cord.
A review of safety data for orlistat (Xenical and Alli) after 32 reports of serious liver-related adverse events, including six cases of liver failure.
A recall of all Accusure insulin syringes, which have needles that can detach from the syringe and become stuck in the insulin vial, push back into the syringe, or remain in the skin.
A public health notification that GDH-PQQ test strips do not distinguish between types of sugars and may falsely indicate hyperglycemia in patients eating products containing non-glucose sugars such as maltose, xylose and galactose.
An update to prescribing information on mycophenolate mofetil (CellCept) to reflect reports of pure red cell aplasia in patients treated with the drug. The prescribing information for mycophenolic acid (Myfortic) was also updated based on reports of pure red cell aplasia in some patients taking the drug.
A class I recall of Stabilet infant warmers because the out-of-date devices may be the ignition source for a fire.
A revision of the warning label for etravirine (Intelence) after reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.
An update to the prescribing information for montelukast (Singulair), zafirlukast (Accolate), zileuton (Zyflo) and zileuton extended release (Zyflo CR) to include information about neuropsychiatric events reported in patients using these products.
A recall of Portex pediatric-sized tracheal tubes (sizes 2.0, 3.0 and 3.5 mm) because the tubes' internal diameters are slightly smaller than indicated on the labeling, as well as a class I recall of Pedi-Cap End-Tidal CO2 Detectors because the devices may increase the resistance of the flow of air into the lungs.
A class I recall of certain LIFEPAK CR Plus automated external defibrillators because an extremely humid environment may cause the devices to improperly analyze the heart rhythm and delay or fail to deliver therapy.
A public health alert on potential dosing errors with oseltamivir (Tamiflu) for oral suspension. The dosing dispenser has markings only in 30, 45 and 60 mg but U.S. health care providers usually write prescriptions for liquid medicines in mL or teaspoons. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg.
Vigabatrin (Sabril), an oral solution to treat infantile spasms in children ages 1 month to 2 years. It is the first drug in the U.S. approved to treat the disorder.
Asenapine (Saphris) tablets to treat adults with schizophrenia and bipolar I disorder. The most common side effects were akathisia, oral hypoesthesia, somnolence for schizophrenia and dizziness, movement disorders and weight increase in bipolar patients.
OVA1, a test to detect ovarian cancer in a pelvic mass that is already known to require surgery. The test scores a blood sample based on levels of five proteins and should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.
Warning letters were issued to eight companies that market unlawful over-the-counter topical drug products containing ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs.
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients taking natalizumab (Tysabri) for multiple sclerosis. The risk for developing PML appears to increase with the number of infusions received, with patients receiving an average of 25 infusions before diagnosis.