Combination Tablet Treats Type 2 Diabetes
The FDA approved Duetact, a combination tablet of pioglitazone (Actos) plus glimepiride 30 mg/2 mg and 30 mg/4 mg tablets, for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already receiving a combination of the two components or whose diabetes is not adequately controlled with a sulfonylurea alone. Duetact is a product of Takeda Pharmaceuticals North America, Inc.
According to Takeda, the two active ingredients are complementary: pioglitazone directly targets insulin resistance and glimepiride acts primarily to increase the amount of insulin produced by the pancreas.
The combination tablets should be administered no more than once daily at either of the tablet strengths to avoid exceeding maximum dosages for pioglitazone (45 mg/day) and glimepiride (8 mg/day).
Consult product labeling for detailed dosing information. Patients should be observed carefully for hypoglycemia for 1 to 2 weeks while transitioning to the new combination therapy. Combination therapy with pioglitazone is not recommended for patients with moderate-to-severe heart failure. Women of childbearing age receiving this combination therapy should be counseled to use adequate contraception because pioglitazone has the potential to cause ovulation in some premenopausal anovulatory women.
Beware of Overexposure with Lidocaine
The FDA approved new safety labeling revisions for lidocaine 5% patch (Lidoderm) to warn about accidental overexposure to the product in children. Lidocaine 5% patches are indicated for relief of pain associated with postherpetic neuralgia.
Serious adverse events may occur if children chew and/or ingest lidocaine patches because of the large amount of lidocaine contained in new and used patches (700 mg and at least 665 mg, respectively). The FDA warns that lidocaine 5% patches should be stored and disposed of away from the reach of children and pets, and for additional safety, used patches and cut pieces should be folded over so that they self-adhere before disposal.
Osteoporosis Medication for Men
Risedronate (Actonel) (Proctor & Gamble/Sanofi-Aventis) 35 mg tablets are now approved for increasing bone mass in men with osteoporosis. Risedronate 35 mg tablets were previously approved for the prevention and treatment of osteoporosis in postmenopausal women.
The new approval was based on a 2-year study of 285 men with osteoporosis. Weekly administration of risedronate produced significant improvements in bone mineral density compared with placebo. The most frequently reported adverse events associated with risedronate treatment in men were similar to those reported in studies of the drug in postmenopausal women: constipation, back pain, arthralgia, influenza, and nasopharyngitis.
Risedronate is contraindicated in patients with hypocalcemia or an inability to sit or stand upright for at least 30 minutes, and it is not recommended for use in patients with severe renal impairment. Consult product labeling for more detailed prescribing information.
Cardiac, Psychotic Issues with ADHD Drugs
New warnings about the risk of cardiac problems and psychotic behavior must be included in the product labeling of several medications used to treat attention deficit hyperactivity disorder. The drugs include dextroamphetamine (Dexedrine) and methylphenidate (Ritalin).
The drugs must also include warnings about the risk of behavior problems such as aggression and mania.
GlaxoSmithKline and FDA notified healthcare professionals of the new warnings concerning dextroamphetamine, which describe reports of sudden death in association with central nervous system stimulant treatment at usual doses in children and adolescents with serious heart problems.