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 15, 2018

    FDA has approved moxidectin 8-mg tablets to treat river blindness (onchocerciasis) in patients aged 12 years and older. FDA has also awarded a priority review voucher (PRV) to the manufacturer, Medicines Development for Global Health (MDGH). 

    River blindness is caused by a parasitic worm, Onchocerca volvulus. The disease manifests as severe itching, disfiguring skin conditions, and visual impairment, including permanent blindness, caused by the worm’s larvae (microfilariae).

    Approval of moxidectin was based on data from two randomized, double-blind, active controlled clinical studies. Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in skin. Full results from the Phase III study were published in the Lancet in January 2018.

    Moxidectin is supplied as 2-mg tablets for administration as an 8-mg dose per oral to patients at least 12 years of age with O. volvulus infection.

  • June 15, 2018

    FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

    Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.

    At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their OUD cut their risk of death from all causes in half.

    One of the ways FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. Generic drugs approved by FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.

    Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema (accumulation of fluid causing swelling in lower limbs). These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

    Mylan Technologies and Dr. Reddy's Laboratories received approval to market buprenorphine and naloxone sublingual film in multiple strengths. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

  • June 14, 2018

    FDA approved bevacizumab for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for Stage III or IV disease after initial surgical resection.

    Approval was based on a multicenter, randomized, double-blind, placebo-controlled, three-arm study evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

    A total of 1,873 patients were randomized to carboplatin plus paclitaxel without bevacizumab, carboplatin plus paclitaxel with bevacizumab for up to six cycles, or carboplatin plus paclitaxel with bevacizumab for six cycles followed by single-agent bevacizumab for up to 16 additional doses. Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. On this trial, 1,215 patients received at least one bevacizumab dose.

    The primary efficacy outcome was investigator-assessed progression-free survival (PFS); overall survival (OS) was a secondary outcome. The estimated median PFS was 18.2 months for patients receiving bevacizumab with chemotherapy followed by single-agent bevacizumab (hazard ratio [HR] 0.62 [95% CI 0.52–0.75]; P < 0.0001). For those receiving bevacizumab with chemotherapy without single-agent bevacizumab, the estimated median PFS was 12.8 months (HR 0.83 [95% CI 0.70–0.98]; not significant).

    For patients receiving chemotherapy without bevacizumab, the estimated median PFS was 12.0 months. Estimated median OS was 43.8 months in the bevacizumab with chemotherapy followed by bevacizumab, compared with 40.6 months in the chemotherapy alone arm (HR 0.89 [95% CI 0.76–1.05]). 

    Adverse reactions occurring at higher incidence (at least 5%) of patients receiving bevacizumab were diarrhea, nausea, stomatitis, fatigue, arthralgia, muscular weakness, pain in extremity, dysarthria, headache, dyspnea, epistaxis, nasal mucosal disorder, and hypertension.

    Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms versus the control arm were fatigue, hypertension, decreased platelet count, and decreased white blood cell count.

    The recommended bevacizumab dose for Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to six cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.

  • June 14, 2018

    FDA granted accelerated approval of pembrolizumab to treat patients with cancer whose unresectable or metastatic solid tumors have a specific genetic feature (biomarker), referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

    This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

    MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial, and gastrointestinal cancers but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland, and other places. Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.

    Pembrolizumab works by targeting the PD-1/PD-L1 cellular pathway. By blocking this pathway, the drug may help the body’s immune system fight the cancer cells. FDA previously approved the agent to treat certain patients with metastatic melanoma, metastatic non–small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

    Safety and efficacy of pembrolizumab for this indication were studied in patients with MSI-H or dMMR solid tumors who were enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began. 

    A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials. The most common cancers were colorectal, endometrial, and other gastrointestinal cancers. Approval for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received pembrolizumab in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for 6 months or more.

    Common adverse effects  include fatigue, pruritus, diarrhea, decreased appetite, rash, fever, cough, difficulty breathing, musculoskeletal pain, constipation, and nausea.

    Pembrolizumab can cause serious conditions, known as immune-mediated adverse effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using pembrolizumab has occurred.

    Patients who experience severe or life-threatening infusion-related reactions should stop taking pembrolizumab. Women who are pregnant or breastfeeding should not take pembrolizumab because it may cause harm to a developing fetus or newborn baby.

    Safety and effectiveness of the agent in pediatric patients with MSI-H central nervous system cancers have not been established.