New anticoagulant and oral MS drug approved

Details on the approval of dabigatran etexilate, and more.

Recalls, warnings

A class I recall of certain lots of Excelsior Disposable 5 ml fill in 6 cc prefilled saline flush syringes with normal saline (0.9 % sodium chloride) because some of these syringes may leak and lose sterility and loss of sterility could result in systemic infection.

Photo by Comstock
Photo by Comstock.

A recall of certain lots of Epoetin alfa (Epogen and Procrit) vials as a precaution, because the vials may contain extremely thin, barely visible glass flakes (lamellae) resulting from the interaction of the formulation with glass vials over the shelf life of the product. The potential adverse events resulting from the use of the affected product by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.

A recall of a number of dietary supplements, including Advanced Muscle Science (Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol), ArimaDex, Clomed, Off Cycle II Hardcore, and iForce–Reversitol, because the products contain aromatase inhibitors and have a reasonable probability of resulting in permanent impairment of a body structure or function in at-risk consumers.

An order to stop manufacturing issued to companies producing and distributing unapproved single-ingredient oral colchicine, used for the treatment of gout. Companies are expected to stop manufacturing the product within 45 days and must stop shipping it in interstate commerce within 90 days. Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market.

A recall of some bottles of Lipitor (40 mg only) due to a small number of reports of an uncharacteristic odor. A medical assessment has determined that the odor is not likely to cause adverse health consequences.

A voluntary market withdrawal of weight loss drug sibutramine (Meridia) because of clinical trial data indicating an increased risk of heart attack and stroke.

A new warning on bisphosphonate medications, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic equivalents), about the risk of subtrochanteric and diaphyseal femur fractures. The warning is based on data showing that the unusual femur fractures have been predominantly reported in patients taking bisphosphonates. The FDA recommends that physicians be aware of the possible risk and evaluate any patient who presents with new thigh or groin pain to rule out a femoral fracture.

A recall of CareFusion Corporation Alaris PC Units (Model 8015) because under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units.

A recall of Tylenol 8 Hour Caplets 50 count bottles following a small number of complaints of a musty or moldy odor. The odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.


Dabigatran etexilate (Pradaxa capsules) for the prevention of stroke and blood clots in patients with atrial fibrillation. The anticoagulant acts by inhibiting thrombin and, unlike warfarin, it does not require monitoring. In a clinical trial, patients taking dabigatran etexilate had fewer strokes than those who took warfarin. The medication was approved with a medication guide that informs patients of a serious bleeding risk.

Fingolimod capsules (Gilenya), the first oral drug to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. Patients should be monitored for a decrease in heart rate upon starting the drug.

A new oral contraceptive (Beyaz) that combines estrogen and progestin and also contains a folate (levomefolate calcium 0.451 mg) tablets. The drug contains the same doses of estrogen and progestin as the previously approved product Yaz, but is also approved for women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.