FDA Actions

The FDA is continuing to review the association of oral contraceptives and thrombotic risk, particularly oral contraceptives containing drospirenone. On October 27, the FDA issued a preliminary Drug Safety Communication, with the full report due out in early December. Reviewing the records of Kaiser Permanente members in California and state Medicaid programs in Tennessee and Washington, which included 835,826 women receiving contraceptive prescriptions from 2001-2007, an increased risk of venous thromboembolism (VTE), deep venous thrombosis, and pulmonary embolism was noted with several contraceptives, with low estrogen hormonal contraceptives as a reference. Products containing drospirenone had relative risk of VTE of 1.74 (95% confidence interval [CI] 1.42-2.14). The norelgestromin/ethinyl estradiol transdermal patch was associated with relative risk of 1.55 (95% CI 1.17-2.07) and etonogestrel/estradiol vaginal ring was associated with a relative risk of 1.56 (95% CI 1.02-2.37). The risk was higher in younger users than older women (www.FDA.gov./DRUGS/DrugSafety/ucm277346.htm).

The FDA has approved the first generic olanzapine (Zyprexa) to treat schizophrenia and bipolar disorder. The generic carries the same warnings as the brand regarding increased risk of death in elderly people with psychosis or dementia. Generic olanzapine will be available from several manufacturers as tablets and orally disintegrating tabs.

The FDA has announced that drotrecogin alfa (Xigris) is being withdrawn from the market by Eli Lilly & Co. The withdrawal is based on the results of the recently completed PROWESS-SHOCK trial in which drotrecogin alfa failed to show a survival benefit in patients with severe sepsis and septic shock. The FDA is recommending that the drug should be stopped in any patients currently being treated and should not be initiated in new patients. All remaining product should be returned to the supplier.

The FDA has approved tadalafil (Cialis) for the treatment of benign prostatic hyperplasia (BPH)either alone or when it occurs along with erectile dysfunction (ED). The drug was approved in 2003 for treatment of ED. The approval was based on two trials in which men taking tadalafil 5 mg daily experienced significant improvements in BPH symptoms compared with those taking placebo. A third study in which men had both BPH and ED, tadalafil 5 mg daily improved both symptoms of BPH and ED compared to placebo. Tadalafil should not be used in patients taking nitrates or in combination with alpha blockers for the treatment of BPH.

The FDA has approved a combination of sitagliptin and simvastatin for the treatment of adults with type 2 diabetes and hypercholesterolemia. This represents the first combination drug for treating these two conditions. The fixed dose combination is available in three strengths: 100 mg sitagliptin/10 mg simvastatin, 100 mg/20 mg, and 100 mg/40 mg. The approval was based on "substantial experience with both sitagliptin and simvastatin" and is a "convenience combination," according to the FDA. Sitagliptin/simvastatin will be marketed as Juvisync by MSD International GmbH Clonmel in Tipperary, Ireland.