Marketing Ban on Unapproved Hydrocodone
The FDA announced that it is taking action against companies that market unapproved prescription products containing hydrocodone, which is widely used as a cough suppressant and to treat pain. Hydrocodone can impair motor skills and judgment, and overdose can cause respiratory problems or cardiac arrest.
Any unapproved hydrocodone products currently labeled for use in children younger than 6 years of age were to end manufacturing and distribution by October 31. Any other unapproved hydrocodone products must stop manufacturing on or before December 31, 2007, and must cease further shipment of interstate commerce on or before March 31, 2008.
The action does not affect other hydrocodone formulations that have FDA approval.
First Topical NSAID Skin Patch in U.S.
The first prescription nonsteroidal anti-inflammatory drug (NSAID) skin patch approved for use in the United States will be marketed by Alpharma, Inc. and is expected to be available in early 2008. The product, diclofenac epolamine (Flector Patch), is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
The Flector Patch is a 10 cm x 14 cm adhesive patch containing 180 mg of diclofenac epolamine. Application to the injured area twice a day results in a local analgesic and anti-inflammatory effect with only minor systemic exposure to diclofenac.
Flector Patch was first approved in Switzerland in 1993 and is approved in 39 countries.
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. Consult product labeling for specific prescribing instructions.
FDA Approves New Indication for Raloxifene
The FDA has approved raloxifene (Evista, Eli Lilly) to reduce the risk for invasive breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer. Raloxifene is only the second drug approved to reduce the risk of breast cancer, according to the FDA.
Raloxifene is approved for the prevention of osteoporosis in postmenopausal women and for the treatment of postmenopausal women with osteoporosis.
The new approval was based on three clinical trials that demonstrated a reduction in the risk of invasive breast cancer by 44% to 71%; a fourth trial in women at high risk for developing invasive breast cancer compared raloxifene to tamoxifen and found the risk of developing invasive breast cancer was similar for the two treatments.
Because raloxifene can cause serious side effects including thromboembolism in the legs and lungs, the benefits and risks of taking the drug should be carefully evaluated for each individual, the agency statement cautioned.
Other potential side effects include hot flashes, leg cramps, edema of the legs and feet, flu-like symptoms, joint pain, and sweating. The drug should not be taken by premenopausal women and women who are or may become pregnant. Consult the product labeling for full prescribing information.
Health Agencies to Study ADHD Drugs
The FDA and the federal Agency for Healthcare Research and Quality are teaming up to create the largest study ever of possible risks associated with medications to treat attention-deficit hyperactivity disorder (ADHD) and the potential for increased risk of myocardial infarction, stroke, or other cardiovascular problems. Approximately 500,000 children and adults who have taken medications to treat ADHD will be examined to determine if the drugs increase cardiovascular risk. The analysis will take about 2 years to complete.
Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about an increased cardiac risk among users of these medications. These risks may be different for adults and children, the FDA notes. Data are needed on the long-term effects of using ADHD medications.