Safety data reviewed; one-dose emergency contraception pill approved


Review of safety data, recalls, label changes

A review of safety data for insulin glargine (Lantus), due to the recent publication of three studies that suggest an increased risk of cancer in patients with diabetes who have used the drug.

Art 1

A recall of several devices made by Hospira, Inc. for defective AC power cords because reports were received of sparking, charring and fires on the plug of the power cord.

A review of safety data for orlistat (Xenical and Alli) after 32 reports of serious liver-related adverse events, including six cases of liver failure.

A recall of two lots of Accusure insulin syringes, which have needles that can detach from the syringe and become stuck in the insulin vial, push back into the syringe, or remain in the skin. The affected syringes are 31 G–Short Needle, either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1, distributed from January 2007 through June 2008.

An update to prescribing information on mycophenolate mofetil (CellCept) to reflect reports of pure red cell aplasia (PRCA) in patients treated with the drug.

The prescribing information for mycophenolic acid (Myfortic) was also updated based on reports of PRCA in some patients taking the drug.

A class I recall of Stabilet infant warmers because the out-of-date devices may be the ignition source for a fire.

A revision of the warning label for etravirine (Intelence) after reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

An update to the prescribing information for montelukast (Singulair), zafirlukast (Accolate), zileuton (Zyflo) and zileuton extended release (Zyflo CR) to include information about neuropsychiatric events reported in patients using these products.

Approvals

A one-dose formulation of emergency contraception pill levonorgestrel (Plan B One-Step). The original pill requires two doses. People aged 17 and older will be able to buy Plan B One-Step over the counter; those 16 and under will need a prescription.

Vigabatrin (Sabril), an oral solution to treat infantile spasms in children ages 1 month to 2 years. It is the first drug in the United States approved to treat the disorder.

Asenapine (Saphris) tablets to treat adults with schizophrenia and bipolar I disorder in adults. The most common side effects were akathisia, oral hypoesthesia, somnolence for schizophrenia and dizziness, movement disorders and weight increase in bipolar patients.

Miscellaneous

The FDA is evaluating the interim findings of an ongoing study of asthma drug omalizumab (Xolair), which suggest an increased risk of several adverse cardiovascular and cerebrovascular conditions. The conditions include ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events. The FDA isn't advising patients to stop taking the drug, nor is it recommending changes to prescribing information at this time, but urges providers to be aware of the potential risks.

Warning letters were issued to eight companies that market unlawful over-the-counter topical drug products containing ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs.