FDA approves buprenorphine implant for opioid dependence
The FDA approved buprenorphine (Probuphine), the first subdermal implant for long-term maintenance treatment of opioid dependence. Probuphine, a partial opioid agonist, is designed to provide a constant, low-level dose of buprenorphine for 6 months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine as part of a complete treatment program that includes counseling and psychosocial support.
Probuphine consists of four ethylene vinyl acetate implants that are implanted under the skin on the inside of the upper arm and provide treatment for 6 months. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. Only healthcare providers who complete the Probuphine Risk Evaluation and Mitigation Strategy Program can insert and remove the implant.
The most common adverse reactions include implant-site pain, pruritus, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain. The safety and efficacy of the medication has not been established in children or adolescents under age 16.
Linagliptin/metformin combination approved for type 2 diabetes
The FDA approved extended-release Jentadueto XR, a once-daily oral combination of linagliptin and metformin hydrochloride, for type 2 diabetes mellitus (T2DM) treatment in adults as an adjunct to diet and exercise. The tablets combine 2.5 mg or 5.0 mg of linagliptin (a dipeptidyl peptidase-4) with 1,000 mg metformin. Jentadueto XR is a product of Boehringer Ingelheim and Eli Lilly.
Linagliptin increases hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose; metformin lowers glucose production via the liver and its absorption in the intestine. Jentadueto XR will carry a label with a Black Box Warning regarding the risk of lactic acidosis from the metformin component. The drug should not be prescribed to those with type 1 diabetes mellitus or diabetic ketoacidosis and has not been studied in patients with a history of pancreatitis.
The safety and efficacy of Jentadueto XR were established in clinical trials of the drug coadministered in patients with T2DM who were inadequately controlled on diet and exercise and in combination with a sulfonylurea.
FDA warns of rare but serious skin reactions linked with olanzapine
The antipsychotic medication olanzapine is associated with a rare but serious skin reaction that can progress to other parts of the body, the FDA warns. The condition, known as drug reaction with eosinophilia and systemic symptoms (DRESS), may start as a rash that spreads to all parts of the body, and can include fever, lymphadenopathy, and facial edema. DRESS causes a higher-than-normal number of eosinophils and can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas. DRESS can lead to death and is a potentially fatal drug reaction with mortality of up to 10%.
Twenty-three cases of DRESS associated with olanzapine were reported worldwide since 1996 when the first olanzapine-containing product was approved. The FDA has added a new warning to the drug labels of all olanzapine-containing products describing DRESS and advises that healthcare professionals immediately stop treatment with olanzapine if DRESS is suspected. Early recognition of the syndrome is important for the management of DRESS because there is no specific treatment for this condition. The olanzapine-containing product should be discontinued as soon as possible, and supportive care should be instituted; treatment with systemic corticosteroids should be considered when there is extensive organ involvement.