FDA approves heart failure drug, looks into antiseptic safety

Recalls, warnings and label changes

A warning that sodium-glucose cotransporter-2 (SGLT2) inhibitors may cause ketoacidosis. There have been 20 cases identified in the FDA's adverse event reporting system, and the agency is investigating the issue to determine whether label changes are needed. Clinicians should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

An alert that household pets are at risk when exposed to topical pain medications containing flurbiprofen, based on reports of cats dying after owners applied the medication to their own necks or feet. Patients who use these medications should take care to prevent pets' exposure, and prescribing clinicians should advise patients of this issue.

A safety alert on LifeCare PCA3 and PCA5 infusion pump systems by Hospira about security vulnerabilities, which, if exploited, could potentially allow an unauthorized user to access the pump remotely and modify the dosage it delivers. Health care organizations should perform risk assessments of their use of the pumps and follow the manufacturer's risk mitigation strategies.

A recall of 1 lot of bupivacaine HCl injection by Hospira due to potential for iron oxide particulate in glass vials.

A recall of 8 lots of fluorouracil (Adrucil) injection by Teva due to the potential presence of particulate matter, identified as aggregate of silicone rubber pieces and fluorouracil crystals.

A recall of certain lots of injectable products by Mylan, including gemcitabine, carboplatin, methotrexate, and cytarabine, due to the presence of visible foreign particulate matter.

An alert that a counterfeit version of onabotulinumtoxinA (Botox) may have been sold to doctors' offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States and it should not be used. The counterfeit product may be identified by the vial missing the lot number, the outer carton not having any entries next to the LOT, MFG, and EXP listings, and the outer carton and vial displaying the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.”

A recall of Tiger Paw System II surgical staples by Maquet Medical Systems, because they may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall. One death and 51 adverse events have been reported.

A recall of 1 lot of reinforced dual-lumen ECMO catheters by OriGen due to potential for a separation of the clear extension tube from the hub.

An alert about quality problems with mammograms performed at Coastal Diagnostic Center in Pismo Beach, Calif., based on the American College of Radiology revoking the facility's accreditation. Patients who had mammograms there on or after Feb. 24, 2013, should consider having their mammograms re-evaluated at a certified facility.

Approvals

Ivabradine (Corlanor) to reduce hospitalization from worsening chronic heart failure. It is indicated for patients with stable symptoms and a normal heartbeat with a resting heart rate of at least 70 beats per minute who are taking beta-blockers at the highest tolerable dose. The drug was approved under priority review based on a trial of 6,505 patients, in which it improved the time to hospitalization for worsening heart failure compared to placebo. The most common side effects were bradycardia, hypertension, atrial fibrillation, and temporary vision disturbance.

The first generic version of glatiramer acetate (Copaxone) injection to treat relapsing forms of multiple sclerosis. The approved generic will be marketed by Sandoz in a 20 mg/1 mL daily injection. The most common adverse reactions have been skin problems at the injection site (redness, pain, swelling, and itching), vasodilation, rash, shortness of breath, and chest pain.

The first generic version of aripiprazole (Abilify) to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals are approved to market generic versions in multiple strengths and forms. All atypical antipsychotics carry a boxed warning about increased risk of death associated with off-label use in older patients with dementia-related psychosis, and aripiprazole's boxed warning also warns of increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

Deoxycholic acid (Kybella), to treat moderate-to-severe fat below the chin, known as submental fat. It is administered as an injection into the fat tissue in the submental area, with up to 50 injections in a single treatment, and up to 6 single treatments administered no less than 1 month apart. Safety and effectiveness are based on 2 clinical trials with 1,022 patients, showing that reductions in submental fat were observed more frequently on the drug than placebo. Serious side effects include nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.

Fibrin sealant (Raplixa) to help control bleeding during surgery. It is a biological product that can help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature, or cautery, are ineffective or impractical. It contains fibrinogen and thrombin and can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge. Approval is based on a study involving 719 patients, which found a reduction in the time needed for bleeding to stop compared to that with an absorbable sponge alone. The most common adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.

Miscellaneous

The FDA has issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients (including alcohol and iodines) used in health care antiseptics, such as hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative skin preparations. The rule is motivated by emerging science suggesting that systemic exposure to these ingredients is higher than previously thought. Existing data also raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients, the agency said. The new data will look at the long-term safety of exposure to these ingredients in health care settings and use of these products by certain populations, including pregnant and breastfeeding health care workers.