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fungal infections 46 articles

FDA warns of dosing errors with antifungal drug Noxafil

Reports of hospitalizations and a patient death related to dosing errors with the antifungal medication Noxafil (posaconazole) have prompted the Food and Drug Administration (FDA) to issue a Drug Safety Communication cautioning health care providers that there has been confusion with differences in dosing regimens between two oral formulations of the drug Noxafil. Noxafil is used to treat or prevent fungal infections such as Aspergillus and Candida, especially in people with weakened immune systems such as those undergoing chemotherapy, stem cell transplantation and those with HIV infections. It is also used to treat a fungal infection called thrush caused by ... Read More

Infant, pediatric support pillows recalled due to mold contamination

Children’s Medical Ventures is recalling all Gel-E Donut gel pillows and Squishon 2 gel cushion products used to help support an infant’s head or body in neonatal or pediatric intensive care units because the products may be contaminated with mold. This issue could cause invasive and life threatening fungal infections to critically ill babies. Children’s Medical Ventures, a Phillips Healthcare business, said the contamination occurred during the manufacturing process. The mold types detected have been identified as types that are commonly found outdoors. The presence of the mold on the pillows and cushions can be transferred to patient environments once ... Read More

Former NECC pharmacist arrested on criminal charges stemming from fungal meningitis outbreak

A man was arrested last week as part of an ongoing investigation into the deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts. Glenn Adam Chin was attempting to board a plane to Hong Kong when federal authorities arrested him on one count of mail fraud. According to the Department of Justice, the maximum sentence under the statute is 20 years in prison followed by three years of supervised release and a $250,000 fine. The U.S. Attorney’s Office and the Civil Division’s Consumer Protection ... Read More

FDA warns doctors, consumers not to use compounded drugs from Unique Pharmaceuticals

The Food and Drug Administration (FDA) is warning health professionals, pharmacies and consumers not to use drugs marked as sterile manufactured by Unique Pharmaceuticals Ltd., because they may be contaminated and using them may result in serious and potentially life threatening infections or death. The FDA conducted two recent inspections of Unique Pharmaceuticals and found unsanitary conditions that inspectors say could compromise the sterility of the purportedly sterile products, which puts patients at risk. The inspections revealed sterility failures in several lots of drug products intended to be sterile, reoccurring contamination problems, and poor sterile production practices. Unique Pharmaceuticals’ products ... Read More

Maker of tainted steroid shots reaches settlement agreement in meningitis outbreak case

Patients and their families harmed or killed by contaminated steroid injections made by New England Compounding Center (NECC) could start receiving compensation next year now that a $100-million multidistrict litigation (MDL) settlement has been reached between the plaintiffs and trustees of the now-bankrupt company. Tuesday’s settlement agreement came as welcome news to dozens of plaintiffs whose lives were marred by a deadly 2012 meningitis outbreak traced to NECC injections that killed 64 people in 20 states and injured 750 others. “There are hundreds of victims and their families feeling some relief today, even though grief for many is still fresh,” ... Read More

Japan approves new type 2 diabetes drug dapagliflozin

Japanese drug authorities have approved Forxiga (dapagliflozin) for the treatment of type 2 diabetes. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, is a once-daily oral treatment that works independent of insulin to help remove excess glucose from the body. It is currently approved in more than 40 countries around the world, including the United States, where it is marketed under the brand name Farxiga. SGLT-2 inhibitors are a relatively new class of diabetes medications. It was the first of its kind to be approved in Europe, and the second, behind Johnson & Johnson’s Invokana, in the United States. The class ... Read More

FDA cracks down on compounding pharmacies, issuing warning letters for unsanitary practices

The Food and Drug Administration (FDA) is coming down hard on compounding pharmacies, issuing warning letters for unsanitary conditions and producing drugs without individual prescriptions. The action comes four months after congress passed the Drug Quality and Security Act, which puts compounding pharmacies that outsource their products under FDA oversight instead of being governed by state pharmacy boards like traditional pharmacies. Nora Apothecary and Alternative Therapies, Pallimed Solutions Inc., and Wedgwood Village Pharmacy received warning letters outlining sterility issues with facility procedures from visible sterile drug contaminants to inadequate clean rooms and monitoring programs. The FDA’s oversight into compounding pharmacies ... Read More

$100 million settlement for fungal meningitis victims expected soon

Victims of the deadly fungal meningitis outbreak linked to contaminated steroid shots could receive a share of a $100 million multidistrict litigation settlement if trustees with the now-bankrupt New England Compounding Center (NECC) and other parties complete a proposed deal. A bankruptcy attorney for the compounding pharmacy responsible for manufacturing and distributing the tainted steroid shots said he has been working with a committee representing victims of the outbreak since the settlements-in-principle were announced in December. He told a Massachusetts federal judge that a completed deal was expected soon. The agreement calls for a victims fund that would first have ... Read More

Europe approves new combination diabetes treatment despite bladder cancer concerns

European drug regulators have approved AstraZeneca and Bristol-Myers Squibb’s combination type 2 diabetes drug Xigduo, making it the first treatment to combine a SGLT2 inhibitor with metformin. Xigduo is a combination of the widely used diabetes drug metformin and dapagliflozin, a new diabetes treatment sold in Europe as Forxiga. It was approved earlier this month by the U.S. Food and Drug Administration (FDA) under the name Farxiga. Dapagliflozin is in a new class of diabetes drugs known as SGLT2 inhibitors. Johnson & Johnson’s SGLT2 Invokana was approved in the U.S. in 2013. Other SGLT2 drugs are currently in development. The ... Read More

FDA approves new type 2 diabetes medication Farxiga

A new drug has been approved by the Food and Drug Administration (FDA) to help regulate blood sugar in patients with type 2 diabetes. Farxiga, developed by AstraZeneca and Bristol-Myers Squibb, has been available in Europe under the name Forxiga. U.S. drug regulators rejected the drug last year because of bladder cancer, heart disease and liver toxicity concerns. Farxiga is the second in a class of drugs known as SGLT2 inhibitors to be approved in the United States. Johnson & Johnson’s Invokana was approved earlier this year. Other drugmakers, including Boehringer Ingelheim, are also developing SGLT2 inhibitors. Drugs in this class ... Read More