Seroquel approved for bipolar depression, mania
Once-daily quetiapine fumarate (Seroquel XR Extended-Release Tablets) are now approved for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. It is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.
Patients should be periodically reassessed to determine the need for continued treatment and the appropriate dose.
Quetiapine fumarate is not approved for the treatment of patients with dementia-related psychosis. For more detail on prescribing precautions and potential adverse reactions, consult the product labeling.
Seroquel XR is a product of AstraZeneca.
HPV vaccine safety information
The CDC and the FDA have published a summary of human papillomavirus (HPV) vaccine (Gardasil) safety monitoring activities and findings for the public and healthcare professionals. On the basis of the review of available information, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks, the agencies state.
The agencies reviewed more than 9,700 reports of health problems following vaccination with Gardasil. Of these, 6% were deemed serious events, including 20 deaths.
New medication for BPH treatment
The FDA approved silodosin (Rapaflo) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH). Silodosin works by blocking the alpha-1 adrenoreceptors in the prostate, bladder, and urethra, which allows the smooth muscle in these tissues to relax, reducing BPH symptoms.
Silodosin is available in a once-daily capsule. An 8 mg daily dose is recommended for men who do not suffer from kidney or liver impairment, and a 4 mg dose will soon be available for men with moderate kidney impairment. The medication is not recommended for men with severe kidney or liver impairment and is not approved for pediatric use.
The safety and efficacy of silodosin were shown in two 12-week, randomized, double-blind, placebo-controlled, multicenter studies using an 8 mg daily dose of the medication. Silodosin produced a statistically significant improvement in BPH symptoms and urinary flow rate compared with placebo.
The most common adverse event reported with silodosin is little or no semen during orgasm. This adverse event does not pose a safety concern and is reversible with discontinuation of the product. Other adverse events include dizziness, light headedness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. Patients planning cataract surgery must notify their ophthalmologist that they are taking silodosin, and patients on alpha-blockers or those who have severe kidney or liver impairment should not use the medication.
Silodosin is a product of Watson Pharmaceuticals Inc.
Darunavir receives expanded indication
The FDA has approved darunavir (Prezista) tablets for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults. The FDA also granted approval to darunavir twice-daily for use in treatment-experienced adult patients.
Darunavir is already approved for use in combination with other antiretrovirals in treatment-experienced adult patients, such as those with HIV-1 that is resistant to more than one protease inhibitor.
Prezista was developed by Tibotec Pharmaceutials and is marketed in the United States by Tibotec Therapeutics, a division of Ortho Biotech Products.