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

    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 is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with sodium–glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. FDA said it is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

    SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood glucose levels in adults with type 2 diabetes. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

    Patients should seek medical attention immediately if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

    Health professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

    Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect. Having diabetes is a risk factor for developing Fournier’s gangrene; however, this condition is still rare among patients with diabetes.

  • August 29, 2018

    Pfizer is voluntarily recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle (NDC 0573-0207-30, lot R51129) because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

    Pfizer concluded that use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose. The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision, and dizziness.

    The product was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018.