Generic irbesartan, escitalopram, ibandronate approved

Recalls, warnings and label changes

A revision to the label of drospirenone-containing contraceptives (Beyaz and Yasmin) noting that some epidemiologic studies reported as high as a threefold increase in the risk of blood clots for these pills compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots. The FDA recommends that clinicians consider the risks and benefits of drospirenone-containing birth control pills and a woman's risk for developing a blood clot before prescribing.

A recall of two lots of cyanocobalamin injection, USP, 100 mcg/mL, 1 mL vial, produced by American Regent, due to cracks in the vials. No adverse events have been reported, but loss of sterility could result in systemic infection, abscess formation, or infection at the injection site.

A warning about a counterfeit version of bevacizumab (Altuzan) 400 mg/16 mL. The FDA warns that the drug has been purchased by U.S. medical practices from foreign sources and was found to contain no active ingredient. In addition, the drug has not been approved for use by the agency.

A recall of argatroban injection, 50 mg/50 mL, due to a potential for visible particulates. No adverse events have been reported, but visible particulates pose a risk of embolization/infarction to organs with potential organ complications.

A warning and dosing clarification for the antidepressant citalopram hydrobromide (Celexa and generic forms) regarding the risk of QT prolongation and torsade de pointes. In August 2011, the FDA advised that citalopram should no longer be used at doses greater than 40 mg/d. Now the maximum recommended dose for patients older than 60 years of age is 20 mg/d. The label has also changed regarding patients with congenital long QT syndrome, in whom use of the drug is now “not recommended” instead of “contraindicated” because some patients with the condition could benefit from a low dose of citalopram and lack viable alternatives.

A class I recall of the Acclarent Inspira AIR balloon dilation system because of potential for the balloon to not deflate or deflate slowly. Four reports of incidents, one resulting in patient injury, have been reported

A recall of the unapproved drug Brilliant Blue G (BBG) due to reports of fungal endophthalmitis in patients who were given the drug during eye surgeries.

A class I recall of Thoratec Corporation's HeartMate II Left Ventricular Assist System because detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow and potentially serious adverse health consequences, including death.

Approvals

The first generic versions of Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) tablets for the treatment of high blood pressure. The generic labels will include all current safety information, including a boxed warning for female patients who are pregnant or may become pregnant. Teva Pharmaceuticals, Inc. will manufacture the generics.

The first generic form of escitalopram tablets (Lexapro) to treat depression and generalized anxiety disorder in adults. Teva Pharmaceutical Industries/IVAX Pharmaceuticals has been granted a 180-day period of generic drug exclusivity and will market generic escitalopram in 5-mg, 10-mg, and 20-mg strengths.

The first generic forms of 150-mg ibandronate (Boniva), a monthly bisphosphonate tablet used for osteoporosis prevention and treatment in postmenopausal women. Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the approved manufacturers of the generic.

The LINX Reflux Management System to treat gastroesophageal reflux disease (GERD) in patients with chronic symptoms despite maximum medical therapy. The device is a series of titanium beads, each with a magnetic core, connected together with independent titanium wires, implanted at the lower esophageal sphincter. Approval is based on two studies, totaling more than 100 patients, which found that benefits outweighed risks. Most common adverse events included difficulty and pain when swallowing food, chest pain, vomiting, and nausea. Patients with the device will not be able to undergo MRI procedures because the magnetic beads interfere.

Peginesatide (Omontys), a new erythropoiesis-stimulating agent to treat anemia in adult dialysis patients who have chronic kidney disease. Approval is based on two trials in which patients received peginesatide once monthly or continued their epoetin treatment. Peginesatide was found as safe and effective as epoetin in maintaining hemoglobin levels within 10 to 12 grams per deciliter.

Florbetapir F 18 injection (Amyvid), a drug for positron emission tomography imaging of the brain to evaluate for Alzheimer's disease (AD) and other causes of cognitive decline. The scan can help estimate the brain β-amyloid neuritic plaque density. A negative scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques and can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition. The scan is not for predicting the development of AD-associated dementia, is not for monitoring patient responses to AD therapy, and does not replace other diagnostic tests used in the evaluation of cognitive impairment. Images should be interpreted only by health care professionals who successfully complete a special training program developed by the manufacturer.

A silicone gel-filled breast implant manufactured by Sientra Inc. for augmentation in women at least 22 years old and reconstruction in women of any age. Approval was based on three years of clinical data from 1,788 participants in which complications and outcomes reflected those found in studies of other breast implants. As a condition of approval, the manufacturer is required to conduct post-approval studies.