Possible increased VTE risk for drospirenone-containing OCs
The FDA notified healthcare providers and patients that two newly published studies evaluating the risk of venous thromboembolism (VTE) in women who use oral contraceptives (OCs) containing the progestin drospirenone found a greater risk of VTE associated with drospirenone-containing OCs compared with OCs that contain levonorgestrel. The studies reported a two to three times greater risk of VTE in women taking drospirenone-containing OCs than was seen among women taking levonorgestrel-containing OCs.
The FDA is evaluating these results and notes that other studies have not reported an increase in risk.
For more information, visit http://www.fda.gov/Safety/MedWatch/SafetyInformation.
Once-daily ER tablets now treat RLS
Gabapentin enacarbil (Horizant) extended-release tablets have been approved for once-daily treatment of moderate-to-severe restless legs syndrome (RLS). Horizant was developed by GlaxoSmithKline and Xenoport.
Data from two 12-week clinical trials of Horizant extended-release tablets in adults showed that those taking the medication experienced an improvement in their RLS symptoms compared with subjects taking placebo.
Horizant will be dispensed with a medication guide explaining the drug's uses and risks. Horizant will carry the same warning as all epilepsy drugs about a potential to possibly cause suicidal thoughts and actions in a small number of people.
Horizant may cause drowsiness and dizziness and can impair the ability to drive or operate complex machinery. For full prescribing instructions, consult the product labeling.
FDA advises low dose for anemia meds
The FDA has advised cutbacks on dosages for erythropoesis-stimulating agents sold by Amgen and Johnson & Johnson, including Aranesp, Epogen, and Procrit. The agency says high doses of these drugs can increase the risk of stroke and other cardiovascular problems in patients with kidney disease.
Studies have not been able to identify a safe dosing level, so the lowest possible dose should be used, according to the FDA.
New treatment for type 2 diabetes approved
The FDA approved linagliptin (Tradjenta) 5-mg oral tablets as an adjunct to diet and exercise and to improve glycemic control in the treatment of type 2 diabetes.
In clinical trials, linagliptin was shown to be safe and effective and to have improved blood glucose control compared with placebo. Linagliptin is a dipeptidyl peptidase-4 inhibitor. It was studied as a monotherapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, and pioglitazone. It has not been studied in combination with insulin and should not used to treat type 1 diabetic patients or those who have diabetic ketoacidosis.
The most common adverse reaction associated with linagliptin is nasopharyngitis. Hypoglycemia was more frequently reported in patients taking a combination of linagliptin and a sulfonylurea. Consult product labeling for warnings and prescribing instructions. Linagliptin is marketed by Boehringer Ingelheim and Eli Lilly.
Coumadin crystalline 5 mg tablets recalled
Bristol-Myers Squibb has initiated a voluntary recall of one lot of 1,000-count bottles of warfarin sodium (Coumadin) crystalline 5 mg tablets because company testing found a tablet in a returned bottle to be of higher-than-expected potency. The affected lot number is: 9H49374A (expiration date September 30, 2012).
For information related to this recall, call Stericycle, Inc. at 1-866-918-8739 and visit http://www.fda.gov/Safety/Recalls/ucm253523.htm.