Medication Monitor

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  • August 20, 2015

    FDA has approved the use of extended-release oxycodone for long-term pain management in children aged 11 to 16 years old. The opioid is intended for pediatric patients whose pain has not responded to alternative treatments.

    Approval for the new indication was based on manufacturer-conducted studies on the safety of extended-release oxycodone and its pharmacokinetic profile in pediatric patients, according to FDA. The painkiller can only be prescribed to children who already tolerate at least 20 mg/d of oxycodone or its equivalent.

    Extended-release oxycodone was reformulated in 2010 to make the drug more difficult to abuse.



  • July 28, 2016

    FDA has approved lixisenatide, a once-daily injection to improve glycemic control in adults with type 2 diabetes when accompanied with diet and exercise.

    Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood glucose levels.

    Its safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. Lixisenatide was evaluated both as a stand-alone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone, and basal insulin. Use of lixisenatide improved glycosylated hemoglobin (A1C) levels in these trials.

    In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either lixisenatide or a placebo in a cardiovascular outcomes trial. Use of lixisenatide did not increase the risk of cardiovascular adverse events in these patients.

    Lixisenatide should not be used to treat patients with type 1 diabetes or those with diabetic ketoacidosis.

    The most common adverse effects associated with lixisenatide are nausea, vomiting, headache, diarrhea, and dizziness. Hypoglycemia in patients treated with both lixisenatide and other antidiabetic drugs, such as sulfonylurea and/or basal insulin, is another common adverse effect.

    In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials.

    FDA is requiring the following postmarketing studies for lixisenatide: clinical studies to evaluate dosing, efficacy and safety in pediatric patients, and a study evaluating the immunogenicity of lixisenatide.

  • May 1, 2011

    A lot of 1,000-count bottles of Coumadin 5 mg tablets (9H49374A) have been voluntarily recalled because the tablets may be a higher potency than expected, FDA said. Testing of a single tablet from a returned bottle of Coumadin showed that it was more potent than it should have been.

  • November 25, 2015

    FDA approved necitumumab in combination with two forms of chemotherapy to treat patients with metastatic squamous non–small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.

    Necitumumab is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors.

    Safety and efficacy of the new agent were evaluated in a multicenter, randomized, open-label clinical study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without necitumumab. Those taking necitumumab plus gemcitabine and cisplatin lived longer on average (11.5 months) compared with those taking only gemcitabine and cisplatin (9.9 months). Necitumumab was not found to be an effective treatment in patients with non-squamous NSCLC.

    The most common adverse effects are skin rash and magnesium deficiency, which can cause muscular weakness, seizure, and irregular heartbeats and can be fatal. 

    Necitumumab includes a boxed warning to alert health care providers of serious risks of treatment, including cardiac arrest and sudden death, as well as hypomagnesemia.


  • November 13, 2015

    FDA granted accelerated approval to osimertinib once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.  

    Approval was based on two multicenter, single-arm, open-label clinical trials in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI (Study 1 and 2).  All patients were required to have EGFR T790M mutation-positive NSCLC as detected by the cobas EGFR mutation test and received osimertinib 80 mg once daily. The major efficacy outcome measure was objective response rate (ORR). Duration of response (DOR) was an additional outcome measure.   Safety data were evaluated in 411 patients who received osimertinib at a dose of 80 mg daily. The most common adverse events were diarrhea, rash, dry skin, nail toxicity, eye disorders, nausea, decreased appetite, and constipation.  

    The most common nonfatal serious adverse events (SAEs) included pneumonia and pulmonary embolus. The most frequent adverse reaction leading to dose reductions or interruptions were prolonged QTc and neutropenia. Adverse events leading to discontinuation included ILD/pneumonitis  and cerebrovascular accident.  

    Fatal adverse events occurred in 3.2% of patients, including four cases of pneumonitis attributed to osimertinib.  

    The recommended dose and schedule for osimertinib is 80 mg given orally once daily.