Finally, additions to the drug label for lovastatin have been added related to drug–drug interactions, contraindications, and dose limitations. This information was evaluated subsequent to the 2011 simvastatin label change, due to similarities in metabolism between both simvastatin and lovastatin. Strong CYP3A4 inhibitors can significantly increase lovastatin exposure leading to rhabdomyolysis. New drug interactions added to the label include hepatitis C virus protease inhibitors and posaconazole. In addition, prescribers should avoid prescribing, and patients should avoid taking, cyclosporine or gemfibrozil with lovastatin, and limit the daily lovastatin dose to 20 mg with danazol, diltiazem, and verapamil. Lovastatin dosing should be limited to 40 mg daily with amiodarone, and patients should avoid drinking more than one quart of grapefruit juice daily if taking lovastatin.
Skin products, mostly cosmetics such as skin lighteners and antiaging products, have been under scrutiny by the FDA due to potential mercury contamination.3 Products with toxic mercury levels have been identified in at least seven U.S. states. Consumers are being warned not to use skin creams, beauty and antiseptic soaps, or lotions which are being marketed to remove age spots, freckles, blemishes, and wrinkles. Most of these products are manufactured abroad and illegally sold in the U.S. in ethnic markets. These products may have also been purchased abroad and brought home for use. Dangerous mercury exposure can include renal failure and nervous system damage. Children can inhale mercury vapors from topically used skin products or ingest products and develop mercury toxicity. Some of the more than 35 products that have been identified have been tested and contain more than 100 times the allowable mercury level. Physicians and patients should be alert to any of these skin products which are likely to contain mercury and have the following ingredients: mercurous chloride, mercuric, mercurio, mercury, or calomel. They should stop using them immediately. You can always call your local poison control center with any questions related to any potential or actual mercury-containing products.
Strontium ranelate (Protelos/Osseor) has been issued a safety warning from the European Medicines Agency (EMEA).4 This agent is not FDA approved. This drug is now contraindicated in patients with venous thromboembolism (VTE) or those who are immobilized due to the increased risk of VTE. The VTE risk also is higher in elderly patients. Additionally, new warnings were updated regarding the development of serious skin reactions, including drug rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Strontium ranelate is approved in Europe to treat postmenopausal osteoporosis.
Drug Approvals
Binosto (alendronate sodium) has been FDA approved as a strawberry-flavored, effervescent tablet for the treatment of postmenopausal osteoporosis.5 It was also FDA approved to increase bone mass in men with osteoporosis. It is available as a once-weekly 70-mg dosage form containing 70 mg alendronate sodium that rapidly dissolves in four ounces of plain, room temperature water, making a buffered solution. It will be available in the third quarter of 2012 and be available in one-month (#4) and 3-month (#12) packages.