Recalls, warnings and label changes
A recall of all products distributed by New England Compounding Center (NECC) in conjunction with an investigation into an outbreak of meningitis among patients who had received an epidural. The FDA asks clinicians to retain, secure and withhold from use of all products distributed by NECC as well as follow up with patients who received an injectable product or cardioplegic solution purchased from or produced by NECC after May 21, 2012.
A recall of certain lots of hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg by Qualitest and Watson Pharmaceuticals due to the potential of some tablets to be oversized and extrapotent.
A warning about certain over-the-counter (OTC) products for muscle and joint pain and rare reports of serious skin injuries, ranging from first- to third-degree chemical burns when the products were applied. The pain relievers contain menthol, methyl salicylate, or capsaicin and are marketed under various brand-names, such as Bengay, Capzasin, Flexall, Icy Hot and Mentholatum. The various formulations include creams, lotions, ointments and patches. When recommending OTC topical muscle and joint pain relievers to patients, clinicians should counsel patients about appropriate use of the products and the risk of serious burns.
A recall of certain lots of Typhim Vi, Typhoid Vi polysaccharide vaccine by Sanofi Pasteur due to the possibility of lower antigen content. There is no safety concern with this recall.
A class I recall of the Neptune Rover Waste Management System, due to one death and one serious injury resulting from tissue damage associated with use of the surgical waste removal systems. Hospitals should cease using the systems and return them to the manufacturer.
A voluntary recall of one lot of Lactated Ringer's and 5% dextrose injection, USP, 1,000 mL flexible container by Hospira, Inc., due to one confirmed customer report of a leak in the primary container between the cobra cap and fill-tube seal. A spore-like structured particulate, consistent with mold, was noted in the solution.
A nationwide recall of Ultra PC% cabinet mount flowmeters by Accutron, Inc., because some of the flowmeters have been found to release nitrous oxide gas when the oxygen is turned off.
An expanded approval of adalimumab (Humira) for moderate-to-severe ulcerative colitis in adults. The anti-tumor necrosis factor is to be used when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. In a clinical trial, 16.5% to 18.5% of patients taking the drug achieved clinical remission compared with 9.2% to 9.3% of those on placebo. It was previously approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and juvenile idiopathic arthritis.
Regorafenib (Stivarga) to treat metastatic colorectal cancer. The multi-kinase inhibitor blocks several enzymes that promote cancer growth and was reviewed under the FDA's priority review program. Patients taking the drug in a trial survived a median of 6.4 months compared to a median of five months on placebo. It carries a boxed warning about the risk of severe and fatal liver toxicity.
A new positron emission tomography (PET) imaging agent (Choline C 11 injection) to detect recurrent prostate cancer in patients whose blood prostate-specific antigen levels are increasing after earlier treatment for prostate cancer. In four studies of about 100 patients, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas. However, falsely positive PET scans were observed in 15% to 47% of the patients.
Teriflunomide (Aubagio), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis. In a trial, the relapse rate of patients on the drug was about 30% lower than the rate for those taking a placebo. It carries a boxed warning about the risk of liver problems, including death, and a risk of birth defects. The most common side effects in clinical trials include diarrhea, abnormal liver tests, nausea and hair loss.
An increased risk of heart failure may be associated with Parkinson's drug pramipexole (Mirapex), the FDA recently announced. Recent studies have suggested such a link, but because the finding was not statistically significant, further review of data is needed before the FDA can determine whether the drug actually increases the risk of heart failure. The agency is currently conducting a safety review and advises clinicians to continue to follow the prescribing recommendations on the drug label. More information will be provided when it is available.