Medication Monitor

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  • July 9, 2018

    FDA approved a labeling supplement for celecoxib, a COX-2 selective NSAID, to include results from a postmarketing cardiovascular outcomes trial that found that at the lowest dose, cardiovascular safety of celecoxib was similar to that of moderate doses of naproxen and ibuprofen.  

    Concerns about the cardiovascular thrombotic risk of COX-2 selective NSAIDs emerged in the early 2000s. Following an FDA Advisory Committee meeting held in 2005, which considered data from large clinical outcome trials in a wide range of indications and epidemiology studies of several individual NSAIDs, FDA concluded that the risk for cardiovascular thrombotic events was present for both COX-2 selective NSAIDs and nonselective NSAIDs.

    The Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen (PRECISION) trial was conducted to address the remaining concerns about the relative cardiovascular safety of COX-2 selective NSAIDS and nonselective NSAIDs. PRECISION was a large, randomized, double-blind controlled trial that began in 2006. Ninety percent of the patients enrolled in the trial had osteoarthritis, and the remaining 10% had rheumatoid arthritis.

    Results of the PRECISION trial demonstrated that celecoxib at the lowest approved dose of 100 mg twice daily is noninferior to (or no worse than) ibuprofen dosed in the range of 600 mg to 800 mg three times daily or naproxen dosed in the range of 375 mg to 500 mg twice daily on a composite cardiovascular endpoint consisting of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

    In an ambulatory blood pressure monitoring study that was part of the larger PRECISION trial, celecoxib dosed at 100 mg twice daily showed little effect on average 24-hour systolic blood pressure (SBP), whereas ibuprofen dosed in the range of 600 mg to 800 mg three times daily and naproxen dosed in the range of 375 mg to 500 mg twice daily increased average 24-hour SBP by 3.7 mmHg and 1.6 mmHg, respectively.

    Too few patients received higher doses of celecoxib to evaluate the risk of cardiovascular events or the effect on blood pressure for doses greater than 100 mg twice daily. The cardiovascular risks of the NSAID class are dose dependent; therefore, the results for celecoxib 100 mg twice daily on the composite cardiovascular endpoint and the lack of effect on SBP cannot be extrapolated to dosing regimens using the higher strengths of celecoxib (200 mg or 400 mg). 

    Patients with recent cardiovascular events such as acute MI, coronary revascularization, or coronary stent placement were not studied in the PRECISION trial. NSAID class labeling warns against use of NSAIDs in such patients.

  • June 25, 2018

    FDA is restricting the use of pembrolizumab and atezolizumab for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

    These changes are the result of decreased survival associated with the use of pembrolizumab or atezolizumab as single therapy compared with platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

    The labels of both drugs have been revised to reflect the restricted indications.

    The tests used in the trial to determine PD-L1 expression are listed in Section 14 of each label.

    FDA is reviewing the findings of ongoing analyses and will communicate new information about the PD-L1 assays and indications as it becomes available.

    In patients already receiving pembrolizumab or atezolizumab who are responding to treatment and are cisplatin ineligible, continuation of treatment could be considered, regardless of PD-L1 status. FDA has not changed the indications of pembrolizumab or atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment.

    Patients taking pembrolizumab or atezolizumab for other approved uses should continue to take their medication as directed by their health professional.

  • 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.