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 20, 2018

    FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API because of inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015.

    This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism.

    FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use. Risks associated with over- or under- treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

    FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.

    However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.”  

    In addition, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices.

    FDA recommends patients talk to their health professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA approved.

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