Medication Monitor

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  • September 11, 2018

    FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir, an antiretroviral medication used to treat HIV. Approved in 2013, dolutegravir has been on the market for 5 years and is available as a single-ingredient product under the brand name Tivicay and as a fixed-dose combination tablet with other HIV medications under the brand names Juluca and Triumeq.

    Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appeared to be at higher risk for these defects.

    Health professionals should inform women of childbearing age about the potential risk of neural tube defects when a dolutegravir-containing regimen is used at the time of conception and early in pregnancy.

    Patients should not stop taking dolutegravir without first talking to their health professional because stopping the medicine can cause the HIV infection to worsen. Stopping dolutegravir without first talking to a prescriber can cause the HIV infection to become worse. 

    More information is available on FDA's website.

    To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. FDA said it is investigating this new safety issue and will update the public when it has more information. Ongoing monitoring will continue as part of the observational study in Botswana. 

  • September 5, 2018

    Merck announced FDA approval of two new HIV-1 medications for adult patients with no prior antiretroviral treatment experience: a once-daily fixed-dose combination tablet of doravirine 100 mg, lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate (TDF) 300 mg, approved under the trade name Delstrigo; and doravirine 100 mg, a new nonnucleoside reverse transcriptase inhibitor that is administered in combination with other antiretroviral medicines and was approved under the trade name Pifeltro. 

    Both drugs are administered orally once daily with or without food.

    Approval was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase III trials, DRIVE-AHEAD and DRIVE-FORWARD.

    Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to 3TC. 

    Delstrigo and Pifeltro are contraindicated when coadministered with drugs that are strong CYP450 3A enzyme inducers because significant decreases in doravirine plasma concentrations may occur and lessen their effectiveness.

    Immune reconstitution syndrome can occur, including autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

    Renal impairment, including acute renal failure and Fanconi syndrome, has been reported with use of TDF. Delstrigo should be avoided with concurrent or recent use of a nephrotoxic agent, as cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

    Common adverse reactions in clinical trials included dizziness (7%), nausea (5%) and abnormal dreams (5%). 

    Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.

  • September 5, 2018

    HelloLife is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev, and Compulsin, within expiry, to the retail and consumer level because of possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

    Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table here) that were manufactured at the King Bio facility in Asheville, NC.

    To date, HelloLife has not received any reports of adverse events related to the recalled products.

  • September 4, 2018

    FDA is warning consumers and health professionals about a voluntary recall of one lot of montelukast sodium tablets (lot #MON17384, expiration 12/31/2019) by Camber Pharmaceuticals. Sealed bottles labeled as montelukast sodium tablets,10 mg, 30-count bottle were found to instead contain 90 tablets of losartan potassium tablets, 50 mg.

    This tablet mix-up may pose a safety risk because taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels, and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus.

    FDA recommends that consumers who have this recalled product contact their health care provider or pharmacist immediately.

    Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.

    This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

    To date, Camber has not received adverse event reports associated with this recall. 

  • August 31, 2018

    FDA has approved lenvatinib capsules for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

    Approval was based on an international, multicenter, randomized, open-label, noninferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC.

    Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight of ≥60 kg and 8 mg orally once daily for patients with a baseline body weight of <60 kg) or sorafenib (400 mg orally twice daily). Treatment continued until radiological disease progression or unacceptable toxicity.

    The trial demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival and a statistically significant improvement in progression-free survival compared with sorafenib. The overall response rate was higher for the lenvatinib arm compared with sorafenib (41% vs. 12% per mRECIST and 19% vs. 7% per RECIST 1.1).

    The most common adverse reactions observed in the lenvatinib-treated patients with HCC (≥20%) in order of decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

    The recommended lenvatinib dosages for patients with HCC are the following: 12 mg orally once daily in patients 60 kg or greater actual body weight or 8 mg orally once daily in patients less than 60 kg actual body weight.