Recalls, warnings and alerts
A recall of some lots of 2% chlorhexidine gluconate cloth patient preoperative skin preparation product because some tested positive for Burkholderia cepacia, which can cause respiratory infections in susceptible patients. The recalled lots are 10722, 10729, 10718, 10357, 10365, 10641, 10672, 10753, 10755 and 10944.
A boxed warning for conventional antipsychotics about an increased risk of death associated with their off-label use in patients with dementia-related psychosis. Atypical antipsychotics carry this risk, as well.
A change in prescribing information to reflect that mycophenolate mofetil (CellCept, Myfortic) may carry a heightened risk of progressive multifocal leukoencephalopathy (PML) for transplant recipients. Doctors should consider PML as a cause if patients develop neurologic symptoms, and possibly consult a neurologist.
Vials of Genentech's Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent should be inspected in light of an increased number of complaints about damaged and broken vials of NDC #50242-0134-68, List #15534, which can lead to a loss of sterility and patient infections.
A boxed warning for becaplermin (Regranex Gel 0.01%) reflecting an increased risk of cancer death in diabetic patients who used three or more tubes of the cream to treat leg and foot ulcers. A retrospective study compared cancer incidence and cancer death among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. There was a five-fold higher risk of cancer death in those who were exposed to three or more tubes of Regranex.
A recall of lot number 91762 of ETHEX Corp.'s morphine sulfate 60-mg extended-release tablets, due to a report of a tablet with twice the appropriate thickness. Such tablets may contain double the dose. The white oval tablet has a “60” on one side and an “E” on the other.
An alert that life-threatening complications are associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine—an unapproved use by FDA. Complications have involved swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Doctors should use alternate treatments or enroll patients in approved clinical trials.
The SPOT-Light HER2 CISH genetic test to determine if patients with breast cancer are good candidates for treatment with trastuzumab (Herceptin), which targets HER2 protein production. If patients have more than two copies of the HER2 gene, they may overproduce HER2 protein and the breast cells will grow and divide too quickly. The test counts the number of HER2 genes in a tumor sample.
The OneTouch Ping Glucose Management System, the first insulin pump that wirelessly communicates with a remote blood glucose meter so patients can calculate and deliver insulin doses without touching their pumps.
Methylphenidate HCl (Concerta), a once-daily pill to treat attention deficit hyperactivity disorder in adults age 18 and older. The drug was already approved for children age 6-17.
Duloxetine HCl (Cymbalta) to treat fibromyalgia. Side effects may include nausea, dry mouth, constipation, lower appetite, sleepiness, sweating and agitation. The drug is already approved to treat depression, anxiety, and diabetic peripheral neuropathic pain.
Marketing of the ELISA DR-70 Blood Test, used to detect and monitor post-surgery tumors in patients with colorectal cancer.
Zoledronic acid (Reclast), for preventing new fractures in patients who recently had a low-trauma hip fracture. The once-yearly, IV bisphosphonate is already indicated for osteoporosis. Side effects may include transient post-dose symptoms like fever and muscle pain, which usually resolve within three days.
Risperidone, the generic version of anti-psychotic Risperdal, which treats schizophrenia, bipolar disorder and other psychiatric conditions.
XIENCE V everolimus-eluting coronary stent to treat coronary artery disease.
The NeuRx DPS RA/4 Respiratory Stimulation System, which uses implanted electrodes to stimulate contraction in the diaphragm and allows some spinal cord injury patients to breathe without a ventilator for at least four hours a day.