Medication Monitor

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  • November 29, 2017

    FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results.

    The agency has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

    Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.

    For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. FDA received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.

    Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests.

    FDA is working with stakeholders to better understand biotin interference with laboratory tests and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.

    FDA is monitoring reports of adverse events associated with biotin interference with laboratory tests and will update the public if significant new information becomes available.

  • November 28, 2017

    Sun Pharmaceutical Industries is voluntarily recalling two lots (A160031A and A160031B) of metformin hydrochloride oral solution, 500 mg/5mL, to the retail level because the product was found to be contaminated with Scopulariopsis brevicaulis.

    Use of the product could result in a risk of infection, especially in immunocompromised patients. The most plausible portal of entry of S. brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis, and disseminated infections. To date, the manufacturer has not received any reports of adverse events related to this recall.

    The product, packaged in 118-mL (4 fl. oz.) and 473-mL (16 fl. oz.) bottles, is indicated to treat type 2 diabetes in adults and children aged 10 years and older.

  • November 21, 2017

    FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat compared with allopurinol, another gout medication. FDA required febuxostat's manufacturer, Takeda, to conduct this safety study when FDA approved the medicine in 2009. 

    Febuxostat is FDA-approved to treat gout in adults and works by lowering uric acid levels in the blood.

    Health professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should not stop taking the medication without first consulting their health provider.

    The febuxostat drug labels already carry a warning and precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared with allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, FDA required an additional safety clinical trial after the drug was approved and on the market to better understand these differences, and that trial was finished recently.

    The safety trial was conducted in more than 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, nondeadly heart attack, nondeadly stroke, and a condition of inadequate blood supply to the heart that requires urgent surgery.

    Preliminary results showed that overall, febuxostat did not increase the risk of these combined events compared with allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.

    Once FDA receives the final results, the agency will conduct a comprehensive review and update the public with any new information.

  • September 26, 2017

    After additional review, FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious adverse effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks.

    FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.

    Health professionals should take several actions and precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. 

    Patients taking MAT drugs should continue to take these medicines as prescribed. They should not stop taking other prescribed medications without first talking to their health professional. 

  • September 25, 2017

    FDA is warning that obeticholic acid is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label.

    Obeticholic acid may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on obeticholic acid are described in the current drug label.

    FDA is working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.

    The agent is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC).

    Health professionals should determine the patient’s baseline liver function before starting obeticholic acid. Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5-mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly. Patients should be monitored frequently for disease progression, and the dosing frequency should be reduced to once or twice weekly for patients who progress to moderate or severe liver impairment.

    In all patients treated with obeticholic acid, monitor frequently for liver injury (e.g., worsened liver blood tests and adverse liver-related reactions that may be inconsistent with the patient’s extent of disease). If liver injury is suspected, discontinue obeticholic acid. After the patient has stabilized, weigh the benefits against the risks when deciding whether to reinitiate treatment. Educate patients on the symptoms of potential liver injury.

    In the 13 months after obeticholic acid was approved in May 2016, FDA received reports of serious liver injury or death associated with its use.

    Nineteen cases of death were identified, of which eight provided information about the patient’s cause of death.