The BD GeneOhm StaphSR Assay, a blood test that can identify in two hours whether genetic material is from MRSA (methicillin-resistant Staphylococcus aureus) bacterium or from bacterium that can be treated with methicillin. The test identified 100% of MRSA infections and more than 98% of other staphylococcus infections in a multicenter clinical trial.
Nebivolol (Bystolic) to treat hypertension. Four clinical trials found it to be as safe and effective as other approved beta blockers.
Delayed release valproic acid capsules (Stavzor) to treat manic episodes associated with bipolar disorder, epilepsy and migraine headaches. The capsules are expected to be available sometime after July 1.
Cetirizine hydrochloride (Zyrtec), to be sold over the counter under store-brand labels for allergy and hive relief.
Voluven, an IV solution that prevents and treats serious blood volume loss during and after surgery. Voluven isn't recommended for dialysis patients, or those with kidney failure or bleeding inside the head.
Alerts, warnings and recalls
The fentanyl transdermal system (Duragesic) should only be used in patients with persistent, moderate-to-severe chronic pain who have taken a daily, around-the-clock narcotic pain medicine for more than a week and are considered opioid-tolerant. The FDA has received reports of death and life-threatening events from fentanyl overdose due to improper use.
A recall of test strips used with the Contour TS Blood Glucose Meter because strips from certain lots could result in readings with a bias showing 5%-17% higher test results. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G, then a series of numbers and letters (for example: WK7ED3E52C). Bottles with other lot numbers aren't affected.
A boxed warning for carbamazepine (Carbatrol, Tegretol, Equetro) now advises patients with Asian ancestry to get a genetic test before taking it so as to identify a higher risk of developing a rare, but serious, skin reaction.
New prescribing information for desmopressin should include the risk of severe hyponatremia, seizures and death for some patients. Desmopressin intranasal formulations are no longer indicated to treat primary nocturnal enuresis (PNE) and shouldn't be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illness that could lead to fluid and/or electrolyte imbalance, as well as during episodes of imbalance like fever, recurrent vomiting or diarrhea.
FDA received reports of patient deaths associated with using radio frequency (RF) ablation devices during lung tumor ablation, a use for which the devices haven't been specifically cleared. It advises special caution when using the devices, and adhering strictly to operating instructions.
Lovastatin (Mevacor) as an over-the-counter drug, because too many people would mistakenly use it, an FDA panel said.
Bevacizumab (Avastin) to treat breast cancer. Already approved to treat colon and lung cancer, the drug was being considered by a panel as an initial treatment for women whose breast cancer had spread or recurred. The FDA is expected to make a final decision this month.
Long-term use of omeprazole (Prilosec) and esomeprazole (Nexium) isn't likely to carry a higher risk of heart problems. The FDA reviewed research on the proton pump inhibitors after receiving results of studies last May that compared the drugs' effectiveness with surgery in treating severe gastroesophageal reflux disease (GERD). The FDA recommends health care providers continue to prescribe the drugs as labeled.
A panel will meet Feb. 20 to discuss icatibant solution for injection (Firazyr), a new drug for treating attacks of hereditary angioedema.