FDA approves glecaprevir-pibrentasvir for HCV – APhA submits compounding comments to FDA.

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FDA approves glecaprevir-pibrentasvir for HCV – APhA submits compounding comments to FDA. – (866) 348-2889

FDA approved on Thursday glecaprevir–pibrentasvir (Mavyret—AbbVie) for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. The combination drug is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. This is the first treatment of 8 weeks duration approved for all HCV genotypes 1-6 in adults without cirrhosis who have not been previously treated. The standard treatment length was previously 12 weeks or more. “This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. Clinical trials involving about 2,300 adults with HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with mild cirrhosis found that 92%–100% of patients who received glecaprevir–pibrentasvir for 8, 12, or 16 weeks duration had no detectable virus in their blood 12 weeks after treatment completion.

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FDA approves treatment for chronic graft versus host disease – Drug for nerve pain boosts high for opioid abusers.

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FDA approves treatment for chronic graft versus host disease – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA expanded on August 2 the approval of ibrutinib (Imbruvica—Pharmacyclics) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, noted: “This approval highlights how a known treatment for cancer is finding a new use in treating a serious and life-threatening condition that may occur in patients with blood cancer who receive a stem cell transplant.” The drug, a kinase inhibitor, was previously approved for certain indications in treating chronic lymphocytic leukemia, Waldenström’s macroglobulinemia and marginal zone lymphoma, as well as under accelerated approval status for mantle cell lymphoma. A single-arm trial of 42 patients with cGVHD whose symptoms persisted despite standard treatment with corticosteroids found that 67% of patients experienced improvements in their cGVHD symptoms. In addition, 48% of patients in the trial saw their symptoms improve for up to 5 months or longer.

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FDA approves new targeted treatment for relapsed or refractory AML – APhA submits compounding comments to FDA.

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FDA approves new targeted treatment for relapsed or refractory AML – APhA submits compounding comments to FDA. – (866) 348-2889

FDA on August 1 approved enasidenib (Idhifa—Celgene) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML. The drug “is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “The use of (enasidenib) was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.” Enasidenib is an isocitrate dehydrogenase-2 inhibitor that works by blocking several enzymes that promote cell growth. If the IDH2 mutation is detected in blood or bone marrow samples using the RealTime IDH2 Assay, the patient may be eligible for treatment with enasidenib. Common adverse events of enasidenib include nausea, vomiting, diarrhea, increased levels of bilirubin, and decreased appetite.

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Cantrell Recalls All Lots of Unexpired Sterile Drug Products – Drug for nerve pain boosts high for opioid abusers.

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Cantrell Recalls All Lots of Unexpired Sterile Drug Products – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Cantrell Drug Company is recalling all lots of unexpired sterile drug products that were distributed from February 16, 2017, through July 19, 2017, to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina, and Vermont. The recall affects all lots that remain within expiry and that are packaged in a syringe or IV bag. To date, Cantrell has not received any reports of adverse events, notes a safety alert posted to Food and Drug Administration’s (FDA’s) website. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program.

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Opioid Misuse Rises Among Older Adults, SAMHSA Reports – APhA submits compounding comments to FDA.

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Opioid Misuse Rises Among Older Adults, SAMHSA Reports – APhA submits compounding comments to FDA. – (866) 348-2889

Opioid misuse among adults aged 50 or older in 2014 was higher than most years between 2002 and 2011, indicates a new spotlight report by Substance Abuse and Mental Health Services Administration (SAMHSA). In contrast, opioid misuse among young adults aged 18 to 25 years decreased from 11.5% in 2002 to 8.1% in 2014. Opioid misuse includes either the use of heroin or the non-medical use of prescription pain relievers. The report, “Opioid Misuse Increases Among Older Adults,” states that data from the 2014 National Survey on Drug Use and Health suggest opioid misuse is increasing among older adults even though the proportion of older adults who misuse opioids is relatively small compared to young adults. In a new SAMHSA press release, Director of the Center for Substance Abuse Treatment Dr Kimberly Johnson said, “The high rates of comorbid illnesses in older populations and the potential for drug interactions has profound implications for the health and well-being of older adults who continue to misuse opioids.”

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HHS OWH Announces Grants to Prevent Opioid Misuse Among Women and Girls – Drug for nerve pain boosts high for opioid abusers.

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HHS OWH Announces Grants to Prevent Opioid Misuse Among Women and Girls – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

In an effort to prevent opioid misuse among women and girls, 16 awards were granted to public and private nonprofit entities across the nation, according to the US Department of Health and Human Services (HHS) Office on Women’s Health (OWH) announcement. Throughout 16 cities in 12 states, 16 projects were selected to address the primary and/or secondary prevention of prescription and illegal opioid misuse by women. The funding will target girls aged 10 to 17 years, women of reproductive age, and women aged 50 years and older in underserved populations. For a list of the organizations each receiving awards of approximately $100,000, visit the HHS news release. “These awards will build partnerships among community-based organizations that consider the unique needs of women and girls; with the ultimate goal of preventing and reducing the impact of the opioid epidemic,” said Chief Medical Officer for the Office of the Assistant Secretary for Health at HHS, Vanila Singh, MD, in the HHS news release.

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FDA Issues Safety Alert for Compounded Triamcinolone and Moxifloxacin Drug – APhA submits compounding comments to FDA.

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FDA Issues Safety Alert for Compounded Triamcinolone and Moxifloxacin Drug – APhA submits compounding comments to FDA. – (866) 348-2889

The FDA has issued a safety alert after receiving serious adverse events reports regarding intravitreal (eye) injections of a medication containing triamcinolone and moxifloxacin.

Adverse events related to the administration of the product were reported in at least 43 patients who received the drug at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center and the Park Central Surgical Center in Dallas, Texas. The drug was compounded by Guardian Pharmacy Services.

According to the reports, patients who were administered the product experienced various symptoms over the course of several months, including vision impairment, poor night vision, loss of color perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. Several symptoms did not appear until at least 1 month after the surgery.

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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death – Drug for nerve pain boosts high for opioid abusers.

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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA on July 28 announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the agency has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products. FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.

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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death – APhA submits compounding comments to FDA.

6Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death – APhA submits compounding comments to FDA. – (866) 348-2889

FDA on July 28 announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the agency has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products. FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.

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Largest Criminal Internet Marketplace, AlphaBay, Seized by DOJ – Drug for nerve pain boosts high for opioid abusers.

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Largest Criminal Internet Marketplace, AlphaBay, Seized by DOJ – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The infrastructure of AlphaBay – which operated for over two years on the dark web and was used to sell deadly illegal drugs and other goods – was seized by the US Department of Justice (DOJ), and involved cooperation and efforts by law enforcement authorities in Thailand, the Netherlands, Lithuania, Canada, the United Kingdom, and France, as well as the European law enforcement agency Europol. The investigation into AlphaBay revealed that numerous vendors sold fentanyl and heroin, and several overdose deaths across the country have been attributed to purchases on the site. AlphaBay was also used to sell stolen and fraudulent identification documents and access devices, counterfeit goods, malware and other computer hacking tools, firearms, and toxic chemicals throughout the world. Alexandre Cazes (also known as Alpha02 and Admin), 25, a Canadian citizen residing in Thailand, was arrested by Thai authorities on behalf of the US for his role as the creator and administrator of AlphaBay.

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