FDA Issues Warnings to Certain Marketers of Products Labeled as Dietary Supplements for Making Unproven Claims – Drug for nerve pain boosts high for opioid abusers.

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FDA Issues Warnings to Certain Marketers of Products Labeled as Dietary Supplements for Making Unproven Claims – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The FDA today posted warning letters issued to 2 companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

Warning letters have been issued by the FDA to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product. Each of these products is marketed as a dietary supplement and declares tianeptine sodium on the label.

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FDA OKs First Treatment for Pediatric, Adult Patients with Rare Immune Disease – APhA submits compounding comments to FDA.

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FDA OKs First Treatment for Pediatric, Adult Patients with Rare Immune Disease – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the FDA have approved emapalumab-lzsg (Gamifant) for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH), making it the first FDA-approved drug specifically indicated for this disease, according to a press release.

HLH is a rare, life-threatening condition in which the body produces too many activated immune cells. The disease, which typically affects children, can cause symptoms such as fever, enlarged liver or spleen, decreased number of blood cells, and neurological abnormalities. It can be inherited, which is known as primary HLH, or have non-inherited causes.

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FDA Approves New Combination HIV Drug – Drug for nerve pain boosts high for opioid abusers.

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FDA Approves New Combination HIV Drug – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The FDA has approved lamivudine and tenofovir disoproxil fumarate (Temixys, Celltrion) tablets, 300 mg/300 mg in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.

The approval of lamivudine and tenofovir disoproxil fumarate tablets authorizes bottles containing 30 once daily tablets. The approval also authorizes bottles containing 60 and 100 tablets for PEPFAR (President’s Emergency Plan for AIDS Relief) use, according to the FDA, in its approval letter to Celltrion, a biopharmaceutical developer in South Korea.

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Eltrombopag Granted FDA Approval for Severe Aplastic Anemia – APhA submits compounding comments to FDA.

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Eltrombopag Granted FDA Approval for Severe Aplastic Anemia – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia (SAA), according to Novartis, the manufacturer of eltrombopag.1 The agency also granted the agent a breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome (H-ARS).

The approval is based on a Novartis analysis sponsored by the National Heart, Lung, and Blood Institute (NHLBI) Division of Intramural Research Program and conducted under a Cooperative Research and Development Agreement. Findings showed that treatment with eltrombopag given concurrently with standard IST led to an overall response rate (ORR) of 79% (95% CI, 69%-87%) and a 44% complete response (CR) rate in patients with definitive IST-naïve SAA, both at 6 months. This compares with a 27% CR rate historically observed with standard IST alone.

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FDA OKs Rifamycin for Travelers’ Diarrhea Caused by Noninvasive E coli – Drug for nerve pain boosts high for opioid abusers.

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FDA OKs Rifamycin for Travelers’ Diarrhea Caused by Noninvasive E coli – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the US Food and Drug Administration (FDA) approved the broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic rifamycin (Aemcolo, Cosmo Technologies, Ltd) for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli not complicated by fever or blood in the stool.

As the most common travel-related illness, travelers’ diarrhea—defined as 3 or more unformed stools in 24 hours—affects about 10% to 40% of individuals who travel each year. Most commonly caused by bacteria found in water, individuals at highest risk are those who travel to most of Asia as well as the Middle East, Africa, Mexico, and Central and South America, according to the FDA.

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E-Cigarette Use Rising Among Youth – APhA submits compounding comments to FDA.

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E-Cigarette Use Rising Among Youth – APhA submits compounding comments to FDA. – (866) 348-2889.

A significant increase in e-cigarette use among middle school and high school students in the United States has driven an overall rise in youth tobacco consumption, according to survey results released by the FDA and the CDC.1

The survey results, published in Morbidity and Mortality Weekly Report, reveal that the number of United States high school students who reported being current e-cigarette users increased 78% to 3.05 million between 2017 and 2018, while the number of middle school students who identified as current e-cigarette users increased 48% to 570,000 during this time period. The survey results also show the high school students who reported being current e-cigarette users also tended to use the product more frequently, with the proportion of those using the product on 20 or more of the past 30 days rising from 20% to 27.7%.

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Survey: Pharmacists Want to Expand Role in Patient Care, but Burdens Must Lessen – Drug for nerve pain boosts high for opioid abusers.

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Survey: Pharmacists Want to Expand Role in Patient Care, but Burdens Must Lessen – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

While pharmacists look forward to an expanded role in patient care, certain activities and barriers need to diminish to help them bring this to reality, according to research presented recently by AmerisourceBergen.

The research, titled: Pharmacy Check-Up: Activity & Barriers to Care Analysis, surveyed 252 pharmacists working in chain, health system, independent and specialty settings between August 27 and September 7. among those in the Pharmacy Industry. The study was conducted by global research company Maru/Matchbox.

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New Clinical Consensus Statement Designed to Address Gout Treatment – APhA submits compounding comments to FDA.

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New Clinical Consensus Statement Designed to Address Gout Treatment – APhA submits compounding comments to FDA. – (866) 348-2889.

Dietary modification, medication adherence, and follow-up care with a health care providers are opportunities to educate patients with gout, according to a joint clinical consensus statement issued recently by The American College of Foot and Ankle Surgeons ACFAS and the American Association of Nurse Practitioners.

Published in the November/December issues of The Journal of Foot & Ankle Surgery and The Journal for Nurse Practitioners, the statement is intended to serve as a discussion guide for the risk factors, diagnosis, treatment and prevention of the disease.

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Updated Campaign Urges Public to Learn Risks of Prediabetes – Drug for nerve pain boosts high for opioid abusers.

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Updated Campaign Urges Public to Learn Risks of Prediabetes – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

An updated campaign sheds light on the fact that more than millions of Americans may be living with prediabetes, and urges them to find out whether they have prediabetes through discussions with their health care providers.

“[We urge the public] to talk with their physician as soon as they find out they may be at risk,” said AMA President Barbara L. McAneny, MD, in a press release about the updated campaign, which was released this week, as part of World Diabetes Day activities. “We encourage anyone who learns through the test that they may be at risk for prediabetes to consult their doctor to confirm a prediabetes diagnosis and find out how lifestyle changes can help them prevent type 2 diabetes.”

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One Health Brings Together Different Health Sectors to Fight Antibiotic Resistance – APhA submits compounding comments to FDA.

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One Health Brings Together Different Health Sectors to Fight Antibiotic Resistance – APhA submits compounding comments to FDA. – (866) 348-2889.

In this clip, Debra Goff, PharmD, FCCP, infectious disease clinical pharmacist and Associate Professor at The Ohio State University, tells Pharmacy Times about One Health, a movement dedicated to bringing together different fields who handle antibiotics to prevent the misuse of these bacteria killing drugs.

Antibiotic resistance is a major global health threat, with an estimated 700,000 deaths occurring from drug-resistant bacterial infections every year, according to a press release from the World Health Organization (WHO). Additionally, drug resistance in animals is a concern, as animals are often affected by the same microbes as humans, with 60% of human diseases traced back to animals. When bacteria in animals becomes drug resistant, humans have a greater risk of being infected with difficult-to-treat diseases, according to the WHO.

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