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 30, 2018

    FDA is warning about genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of adverse effects compared with other medications due to genetic variations.

    Results from these tests may also indicate that the health care provider can or should change a patient's medication on the basis of these test results. FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, sufficient clinical evidence is not currently available for these genetic tests or software programs, and therefore, these claims are not supported for most medications.

    According to the agency, patients and health care providers should not make changes to a patient's medication regimen on the basis of results from genetic tests that claim to predict a patient's response to specific medications, but are not supported by sufficient scientific or clinical evidence to support this use. Doing so may put the patient at risk for potentially serious health consequences.

    There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA-approved medications. FDA-authorized labels for these medical products may provide general information on how DNA variations may affect the levels of a medication in a person's body, or they may describe how genetic information can be used to determine therapeutic treatment, depending on the available evidence.

    Recommendations for health care providers and laboratories

    • If you are using, or considering using, a genetic test to predict a patient's response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication's effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
    • If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person's response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
    • Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is sufficient evidence to support making treatment decisions based on the information provided by the genetic test.
    • Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
    • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by FDA.

  • 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.