Recalls and warnings
A recall of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) with Catalogue No. 1355 or 102139. Wear and tear of the percutaneous lead connecting the pump with the system controller may interrupt pump function, and has led to 27 pumps needing to be replaced. Five people have died because their pumps couldn't be replaced. The estimated probability of the need to replace a pump because of lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months. All patients with the pump should be assessed by their doctors.
A class I recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The pumps have potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump, which have resulted in a blockage between the sutureless pump connector and the catheter port on the pump, and disconnection from the pump connector.
A recall of three lots (77946, 81141 and 81142) of dextroamphetamine sulfate 5 mg tablets due to the possible presence of oversized tablets, which may contain nearly twice the labeled amount of active ingredient. The recalled lots were distributed under an “ETHEX” label between January 2007 and May 2008. It is an orange round tablet with “ETHEX” and “311” on one side.
A warning about serious complications associated with transvaginal placement of surgical mesh to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). FDA has received more than 1,000 reports in three years of complications including erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. FDA recommends physicians get specialized training in mesh placement, watch for complications and tell patients about the risks.
Warnings to Bayer HealthCare about marketing two unapproved aspirin products, Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage. Bayer Women's is labeled for use against osteoporosis; both are labeled for use in lowering cardiac risk. These uses require a health care professional's supervision, so the products shouldn't be sold over-the-counter.
A warning letter to Lab Corporation of America for marketing OvaSure, a test the company says can detect ovarian cancer, without having FDA approval for the test.
Cinryze, a C1-esterase inhibitor, to prevent hereditary angioedema (HAE) attacks that can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. The IV drug can be used every 3-4 days for routine prevention.
Akten Ophthalmic Gel 3.5%, a topical eye anesthetic for use in cataract, refractive surgery and Lasik surgery. Boston Scientific's Taxus Liberte drug-coated stent, the follow-up to its Taxus Express2 stent.
Quetiapine (Seroquel XL), to treat both depressive and manic episodes of bipolar disorder. The drug is already approved to treat schizophrenia.
The NeuroStar transcranial magnetic stimulation device for treating depressed adults after one antidepressant has failed to work. The treatment uses a magnetic field to induce a small electric current in a certain part of the brain. Unlike electroconvulsive therapy, it doesn't cause seizure or loss of consciousness. It isn't meant to be used with patients who have tried more than one antidepressant.
Silodosin (Rapaflo) to treat symptoms of benign prostatic hyperplasia (BPH). The once-daily capsule is recommended at 8 mg for men without kidney or liver impairment, and 4 mg for those with moderate renal impairment. It's not recommended for men with severe renal or liver problems. Patients should be examined prior to therapy to rule out prostate cancer. The most common side effect is reduced or no semen during orgasm, but this stops when the patients stops using the drug.