Medication Monitor



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  • April 25, 2019

    FDA has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an OTC naloxone product.

    Though the approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, generic injectable naloxone products have been available for years for use in a health care setting. FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

    In a press announcement, FDA said that while business and other considerations may affect how quickly this product becomes available, the approval is an important step for the agency as it works toward expanding access to this live-saving drug. FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.

    Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

    Use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

  • April 25, 2019

    SD Import is voluntarily recalling all lots of aphrodisiac capsules to the consumer level. An FDA analysis found the product is tainted with sildenafil, an FDA-approved active pharmaceutical ingredient (API) used to treat erectile dysfunction. Presence of the sildenafil renders the capsules an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

    Consumers with diabetes, hypertension, high cholesterol, or heart disease often take nitrates; consumption of undeclared sildenafil along with nitrates could result in a drop in blood pressure that is life-threatening and could result in serious adverse health consequences. 

    Aphrodisiac capsules are marketed as a dietary supplement for men for sexual enhancement and are packaged in a cardboard box with 12 plastic packs in a box (UPC Code 644118128135). The product was distributed nationwide to retail stores and a variety of online websites.

    SD Imports is notifying its distributors and customers by e-mail and arranging for return of all recalled products.

    The company indicated that, to date, it has not received any reports of adverse events related to this recall.

  • April 24, 2019

    FDA approved two new indications for pembrolizumab:

    –First-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation for metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥ 1%), as determined by an FDA-approved test.

    –With axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Approval for stage III or IV NSCLC was based on KEYNOTE‑042, a randomized, multicenter, open-label, active-controlled trial conducted in 1,274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumors expressed PD-L1 (TPS ≥ 1%). The trial demonstrated statistically significant OS improvements for those randomized to pembrolizumab compared with chemotherapy in all three populations.

    The recommended dosage for NSCLC is 200 mg as an I.V. infusion over 30 minutes every 3 weeks. The most common adverse reactions are fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.

    Approval for RCC was based on KEYNOTE‑426, a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumor expression status and were randomly allocated to receive either pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally twice daily, or sunitinib 50 mg orally once daily for 4 weeks and then off treatment for 2 weeks.

    Treatment continued until confirmed disease progression or unacceptable toxicity. Pembrolizumab was received for maximum of 24 months.

    The recommended dosage for this indication is pembrolizumab 200 mg every 3 weeks with axitinib 5 mg orally twice daily.

    The most common adverse reactions for pembrolizumab plus axitinib are diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.  

     

  • April 10, 2019

    FDA is extending the indication of palbociclib capsules in combination with specific endocrine therapies for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer in male patients.

    Palbociclib was initially approved in 2015 in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy.

    The most common adverse effects are infections, leukopenia  fatigue, nausea, stomatitis, anemia  hair loss, diarrhea, and thrombocytopenia. Other common adverse effects are rash, vomiting, decreased appetite, asthenia, and fever.

    Health care providers are advised to monitor a patient’s blood count for neutropenia. Patients should have their blood count checked before starting palbociclib and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated.

    Because of the potential for genotoxicity, health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. Women who are pregnant or breastfeeding should not take palbociclib because it may cause harm to a developing fetus or newborn baby.

  • April 10, 2019

    US WorldMeds announced that its subsidiary, Sloan Pharma, has received FDA approval to reintroduce tegaserod, a twice-daily oral treatment for irritable bowel syndrome with constipation (IBS-C) in women younger than 65.

    Tegaserod was originally approved by FDA in 2002 for treatment of IBS-C in women. It was voluntarily withdrawn from the U.S. market in 2007 because of safety concerns. The drug has remained consistently available in the United States through an expanded access program authorized by FDA and is used by patients with IBS-C in several other countries.

    Approval to reintroduce the agent came after a complete safety review by FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on evaluation of clinical data from 29 placebo-controlled trials and newly available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported its reintroduction for appropriate patients with IBS-C.

    Tegaserod is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. The drug targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the GI tract to induce contraction and relaxation and decrease pain signaling.

    In clinical trials, patients taking tegaserod saw improvement in some of the most bothersome IBS-C symptoms. In the first 4 weeks, significantly more patients treated with tegaserod than placebo-treated patients reported an improvement in their abdominal pain/discomfort and bloating. Frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month one.

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