Recalls and warnings
A recall of all lots of sterile and non-sterile alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad Group and sold under the names Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS and Conzellin due to concerns about potential contamination with Bacillus cereus. The recall prompted the FDA to remind clinicians that non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures (such as catheter insertion or surgery) and should not be used in hospitals or on patients with depressed immune systems.
A class I recall of CombiSet True Flow Series hemodialysis blood tubing set with priming set and transducer protectors for use with a blood volume monitor, due to the risk of kinking of the arterial line which can cause the destruction of red blood cells and may result in serious injury and/or death.
A labeling change on rosiglitazone medications (Avandia, Avandamet, Avandaryl) describing the drug's cardiovascular risks and noting that the drug should only be used in patients already being treated with these medicines or those whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines.
A recall of certain lots of American Regent potassium phosphates injection and sodium thiosulfate injection because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
A class I recall of the Merit Prelude short sheath catheter introducer because the tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, and/or introducer tip material may enter into the bloodstream, causing thrombosis.
A recall by Qualitest Pharmaceuticals of certain lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg, and phenobarbital tablets, USP 32.4 mg, after an individual bottle of hydrocodone bitartrate and acetaminophen tablets was found incorrectly labeled with a phenobarbital tablets label. As a result of this mix-up, patients may unintentionally take the wrong medication. Unintentional administration of hydrocodone or acetaminophen may result in serious adverse events. Additionally, missing doses of phenobarbital could result in loss of seizure control.
A class I recall of the Arstasis One Access System because components may fracture and/or separate during use, which may result in patient harm.
A strengthened warning on topiramate (Topamax and generic versions) about the increased risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy. Before prescribing topiramate, which is approved to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches, health care professionals should warn women of childbearing age about the potential hazard.
A market removal of a large number of prescription oral cough, cold, and allergy products because the drugs lack FDA approval due to changes in approval regulations. The products may contain risky combinations of ingredients, release active ingredients too slowly, too quickly, or inconsistently, or look or sound similar to other products, and therefore pose unnecessary risk.
A class I recall of central venous catheter trays distributed by Cook Inc. because leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility, which may lead to serious adverse health consequences and/or death.
A recall of the ACCU-CHEK FlexLink Plus infusion set, because of the potential for under delivery of insulin due to a kinked/bent cannula. If this remains unnoticed, it can result in under delivery leading to elevation of blood glucose levels.
A new warning on prescription proton pump inhibitors (PPIs) noting that the drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPIs and periodically during therapy in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia.
A warning that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor of the potential for serious maternal heart problems and death. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and poses similar safety concerns.
A recall of several medications manufactured by Upsher-Smith Laboratories after a bottle labeled as Jantoven warfarin sodium 3-mg tablets was found by a pharmacy to contain 10-mg tablets. The recall includes batches of amantadine, amlodipine, Androxy, baclofen, bethanechol, Jantoven and oxybutynin.
A labeling change on all antipsychotic drugs to contain more and consistent information about the potential risk for extrapyramidal signs and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
An additional indication of the human papillomavirus vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages 9 through 26 years. The vaccine was studied in a randomized, controlled trial of men who self-identified as having sex with men in which it was shown to be 78% effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia.
Spinosad (Natroba) topical suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older. The safety and effectiveness of the drug was established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment was approximately 86% compared to 44% of the control group. Common adverse events included redness or irritation of the eyes and skin. The product should be applied only to the child's scalp or hair.
Vilazodone hydrochloride (Viibryd), a combined selective serotonin reuptake inhibitor and serotonin 1A receptor partial agonist to treat major depressive disorder in adults. The drug will be available in 10, 20 and 40 milligram tablets and the most frequent adverse reactions reported by patients in clinical trials included diarrhea, nausea, vomiting, and insomnia. Like all other antidepressant drugs, it will have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
Hydroxyprogesterone caproate (Makena) injection for pregnant women with a history of at least one spontaneous preterm birth, to reduce the risk of delivery before 37 weeks of pregnancy. The FDA approved this drug under the agency's accelerated approval regulations that allow promising drugs to be approved while additional studies are ongoing. In a trial of 463 women who had a history of a prior spontaneous preterm birth, 37% of those taking the drug delivered early as compared with 55% of controls. The injections are given once a week into the hip, beginning at 16 weeks and no later than 21 weeks of pregnancy.
The first mobile radiology application for viewing medical images on the iPhone and iPad. The application allows physicians to view images and make medical diagnoses based on computed tomography, magnetic resonance imaging, and nuclear medicine technology, such as positron emission tomography. It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.
An FDA review has found a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL). Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. The FDA is recommending that health care professionals consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant.
The FDA ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced. An FDA analysis of adverse event reports found a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device based on premarket mechanical testing. The FDA is not currently recommending any changes in use of the implants but may issue recommendations after reviewing additional clinical data from the manufacturers.