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OTC cough medicine questions arise

The FDA issued a Public Health Advisory concerning the use of over-the-counter (OTC) cough/cold products in children and its adverse events. The problems appear to arise when children are given more than the recommended dosage of OTC cough/cold medications, receive them too often, or are given more than one product containing the same active ingredient. The agency recommended that parents carefully follow directions for use of these products as found in the drug facts box on the package labels when using these medications in children. Other recommendations on the use of OTC cough/cold products are also provided in the advisory, which can be found at:


The FDA convened a meeting of the Nonprescription Drugs Advisory Committee to discuss the safety and effectiveness of cough/cold drug products when used by children. The agency reviewed safety and efficacy data prior to the meeting because of questions on the safety of these medications and whether their benefits justify any potential risks from use in children, especially those younger than 2 years of age.

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New indications approved for risperidone

The FDA approved Janssen's risperidone (Risperdal) tablets for two new indications: as a treatment for schizophrenia in adolescents age 13 to 17 and as monotherapy for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents age 10 to 17. This is the first FDA approval of an atypical antipsychotic medication to treat either disorder in these age groups.


Previously, there was no FDA-approved drug for the treatment of schizophrenia for pediatric use, and lithium was the only drug approved for the treatment of bipolar disorder in adolescents ages 12 years and up.


The efficacy of risperidone for these indications was demonstrated in clinical trials. The most common side effects were drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash.


Once-yearly osteoporosis drug approved

Zoledronic acid 5mg (Reclast, Novartis) has been approved for the treatment of postmenopausal osteoporosis. This medication is administered as a once-yearly 15-minute I.V. infusion. Zoledronic acid injection was previously approved for treatment of Paget's disease. Zoledronic acid (Zometa) by infusion is approved for treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases of solid tumors.


The FDA based its approval on data from a 3-year trial of the once-yearly treatment which showed that zoledronic acid decreased the risk of morphometric vertebral fractures by 70% and the risk for hip fractures by 41%. The reduction in spine fracture risk was sustained during the 3-year trial period. Women receiving zoledronic acid injection therapy also had significant mean increases in bone mineral density at the hip, lumbar spine, and femoral neck relative to placebo.


Treatment with zoledronic acid injection was generally well tolerated. The most commonly reported adverse events postdose were fever, muscle pain, flulike symptoms, headache, and bone pain that generally resolved within 3 days and decreased in incidence with subsequent doses. No spontaneous cases of osteonecrosis of the jaw were seen in this study.


First topical NSAID skin patch available in the United States

The first prescription nonsteroidal anti-inflammatory drug (NSAID) skin patch approved for use in the United States is expected to be available early this year. The product, diclofenac epolamine (Flector Patch), is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. The product 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.


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 woman, 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 shouldn't be taken by premenopausal women and women who are or may become pregnant. Consult the product labeling for full prescribing information.


Unapproved hydrocodone gets marketing ban

The FDA announced that it's 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, 2007. Any other unapproved hydrocodone products must cease further shipment of interstate commerce on or before March 31. The action doesn't affect other hydrocodone formulations that have FDA approval.


The agency has received reports of medication errors associated with unapproved hydrocodone products and confusion over the similar names of unapproved products and approved ones. According to the FDA, most of the hydrocodone formulations now marketed as cough suppressants haven't been approved.


Stronger warning added to diabetes drugs

Manufacturers of drugs in the thiazolidinedione class of type 2 diabetes medications have agreed to add a stronger warning label about the risk of heart failure. The upgraded boxed warning will emphasize that the drugs may cause or worsen heart failure in certain patients.


A review of postmarketing data showed that the updated warning was necessary for the entire class of drugs, which includes rosiglitazone (Avandia), pioglitazone (Actos), rosiglitazone-glimepiride (Avandaryl), rosiglitazone-metformin (Avandamet), and pioglitazone-glimepiride (Duetact). The FDA is concerned the drugs are being prescribed to patients with inadequate monitoring for signs of heart failure.


The strengthened warning advises healthcare professionals to observe patients carefully for signs and symptoms of heart failure. The warning also states that these drugs should not be used by people with serious or severe heart failure.

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