Off-label use of antipsychotics for some treatments not supported
Although clinicians continue to prescribe atypical antipsychotics for off-label indications, there is little evidence to support this action, according to a new report from the U.S. Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ).
The report finds that atypical antipsychotics are commonly prescribed to treat behavioral conditions for which they are not FDA-approved.
The strongest evidence for off-label use of antipsychotics was for risperidone, olanzapine, aripiprazole to treat the symptoms of dementia; quetiapine to treat generalized anxiety disorder; and risperidone to treat obsessive-compulsive disorder. However, there was no evidence to justify the use of these and other atypical antipsychotic drugs to treat substance abuse problems, eating disorders, or insomnia. These medications have been linked to some harm, including a small increased risk of death in elderly patients with dementia.
The report also cautioned against assuming that all atypical antipsychotics are similar since these drugs vary in effectiveness and adverse effects.
OTC asthma inhalers with CFCs taken off the market
The FDA announced that epinephrine inhalers containing chlorofluorocarbons (CFCs) will not be made or sold in the United States after December 31, 2011.
The only FDA-approved epinephrine inhaler sold over the counter for the temporary relief of occasional symptoms of mild asthma is Primatene Mist, marketed by Armstrong Pharmaceuticals. The product uses CFCs to propel the medication out of the inhaler. To comply with an international agreement that phases out CFCs because of concerns that they deplete the ozone layer, no CFC-containing inhalers can be made or sold after the end of 2011. While many manufacturers have changed their inhalers to replace CFCs with an environmentally friendly propellant, hydrofluoroalkane (HFA), there is currently no HFA version of epinephrine inhalers.
The FDA notes there are many other safe and effective inhalers to treat asthma symptoms, but all require a prescription.
Certain OCs recalled due to packaging error
Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives (OCs) because of a packaging error that may result in an incorrect daily regimen, leaving women without adequate contraception and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, according to the FDA, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
This recall includes affected lots of Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem.
New indication for denosumab for bone loss in cancer patients
The FDA approved the use of Amgen's denosumab (Prolia) to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer, and as a treatment to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer.
Denosumab is the first and only treatment approved for cancer-treatment-induced bone loss in patients undergoing hormone ablation therapy. According to the FDA, denosumab also reduced the incidence of vertebral fractures in patients with prostate cancer.
Denosumab was previously approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Denosumab is contraindicated in patients with hypocalcemia. Consult product labeling for specific prescribing instructions and precautions.