Medication Monitor

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  • 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.

  • August 29, 2018

    Accord Healthcare is voluntarily recalling one lot (#PW05264 – 46632 bottles, NDC 16729-182-01) of hydrochlorothiazide tablets 12.5 mg to the consumer level.

    A 100-count bottle was found to contain 100 spironolactone tablets 25 mg. Since the individual lot of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

    Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of hydrochlorothiazide tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

    More information is available on FDA's website.

  • August 29, 2018

    Product Quest Manufacturing is voluntarily recalling lot #173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level.

    The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

    More information is available here.

  • August 29, 2018

    AbbVie announced FDA approval of ibrutinib plus rituximab to treat adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non–Hodgkin lymphoma. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected.

    With this approval, ibrutinib plus rituximab is the first and only chemotherapy-free combination treatment indicated specifically for the disease.

    The first-in-class Bruton's tyrosine kinase inhibitor was first approved as a single-agent therapy for WM in January 2015

    FDA approval of the combination for treatment of WM was supported by data from the Phase III iNNOVATE trial evaluating ibrutinib in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM.

    The most common adverse reactions (occurring in 20% or more of patients) in the iNNOVATE study were bruising, musculoskeletal pain, hemorrhage, diarrhea, rash, arthralgia, nausea, and hypertension.

    In combination with rituximab or as a single agent, the recommended dose for adults with WM is 420 mg taken orally once daily until disease progression or unacceptable toxicity.