Medication Monitor

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  • June 15, 2018

    FDA is alerting health professionals of adverse events associated with a drug containing triamcinolone (a steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas. FDA received adverse event reports on April 5 and June 1, 2017, and conducted follow-up concerning at least 43 patients who were administered intravitreal (eye) injections of the drug at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center.

    The purpose of the injection was to provide postoperative prophylaxis for ocular inflammation and endophthalmitis with the expectation that the patient would not need to use postoperative eye drops.

    Over the course of several months, patients developed various symptoms, including vision impairment (blurred or decreased vision), poor night vision, loss of color perception, photophobia (light sensitivity), glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. A number of the symptoms were not exhibited until at least 1 month postoperatively.

    During follow-up examinations, physicians observed that the patients had diminished visual function involving both visual acuity and visual fields. Optical coherence tomography testing initially showed macular edema, which was followed in some cases by retinal degeneration. While the symptoms reportedly improved in some patients over the 5-month postoperative period, a number of patients remain with a significant reduction in best-corrected visual acuity and visual fields.

  • June 2, 2018

    FDA is alerting health professionals, patients, and the drug supply chain of stolen injectable fertility medications Gonal-f RFF Redi-ject, Gonal-f Multi-Dose (follitropin alfa injection). Patients who have product with these lot numbers should not use them.

    All product with these lot numbers were in this stolen shipment. The lot numbers are located on the flap of each box, below the tamper-proof seal and next to the 2D barcode.

    The products were stolen in Italy on May 17, 2018, and were intended to be shipped to the United States. EMD Serono of Rockland, MA, reported the theft of more than 16,000 packages of follitropin alfa injection to FDA on May 18, 2018.

    Drug supply chain stakeholders that receive or possess these lot numbers must notify FDA via Form FDA 3911. Anyone who has received suspicious or unsolicited offers to purchase follitropin alfa injection products since May 17, 2018, should contact FDA Office of Criminal Investigations at 800-551-3989. 

    Drug supply chain stakeholders should continue to remain vigilant when buying or selling these products and check the lot number to prevent stolen product from entering the drug supply chain.

    Patients, health professionals, and drug supply chain stakeholders should check the product and label for signs of tampering before using.

    FDA also reminds health professionals, patients, and drug supply chain stakeholders to purchase products only from licensed wholesale distributors and pharmacies. See FDA’s Know Your Source and BeSafeRx programs for more information.

  • June 2, 2018

    FDA announced a recall of one lot of fluticasone propionate nasal spray 50 mcg per spray, 120 metered sprays (lot# NJ4501, expiration date July 2020). The product may contain small glass particles that could block the actuator, impact the functionality of the pump, and cause local trauma to the nasal mucosa in individuals who use it.

    The issue was discovered through a customer complaint. 

    The spray is indicated for treatment of seasonal and perennial allergic rhinitis and management of sinus pain and pressure associated with allergic rhinitis in patients 4 to 17 years of age.

    Patients, wholesalers, retailers, hospitals, or institutions should stop use and distribution of the remaining units and quarantine immediately.

  • June 2, 2018

    Allergan issued a voluntary recall of one lot (#5620706, Expiry May-2019) of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 1 mg/20 mcg, 6 x 28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack. Specifically, the first four days of therapy had four nonhormonal placebo capsules instead of active capsules.

    Oral contraceptive capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversed order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order.

    The product was distributed Nationwide to healthcare providers.

    Please refer here to the affected lot number as well as photographs of the affected product.

  • May 24, 2018

    FDA is warning that OTC teething products containing the pain reliever benzocaine pose a serious risk of methemoglobinemia in infants and children younger than 2 years old and should no longer be used, marketed, or sold. 

    This dangerous condition is the result of elevated levels of methemoglobin in the blood and can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced. 

    Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores, and irritation of the mouth and gums. The products are sold as gels, sprays, ointments, solutions, and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics. 

    Signs and symptoms of methemoglobinemia include pale or gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate. These adverse effects may occur after using benzocaine for the first time or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine. If any of these symptoms occur, the person should receive medical attention immediately. 

    FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to FDA’s letter about these new safety labeling dhanges. If companies do not comply, FDA stated it will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

    FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their health professional for safe alternatives.

    When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient.

    For advice on treating teething pain, FDA suggests the American Academy of Pediatrics’ (AAP) recommendationsdisclaimer icon.