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fungal infections 46 articles

New type 2 diabetes drug Invokana must prove its safety, efficacy with doctors

Last spring, Johnson & Johnson’s new type 2 diabetes drug Invokana, previously known as canagliflozen, became the first medication approved in the United States from a new class of drugs known as SGLT-2 inhibitors. While the honor of being the first treatment in a drug class has its benefits, it also has drawbacks. Novel drugs offer the promise of a new approach to treating diseases and conditions, but they are also met with caution by doctors, many of whom prefer to take a wait-and-see approach, until more safety and efficacy data comes available. These drugs, like Invokana, are being pitted ... Read More

NECC agrees to pay more than $100 million to compensate victims of fungal meningitis outbreak

The owners and insurers of the Massachusetts compounding pharmacy blamed for a deadly, multistate fungal meningitis outbreak have agreed to pay more than $100 million to settle lawsuits and compensate victims, families of victims and creditors. At least 751 people were sickened and 64 died after receiving contaminated steroid injections manufactured by New England Compounding Center (NECC). About 18,000 tainted shots were distributed to medical facilities in 23 states, and an estimated 14,000 people were exposed to the fungus after receiving the shots commonly used to treat back, neck and joint pain. Hundreds of patients developed fungal infections, including meningitis. ... Read More

Bill requires more government oversight for larger compounding pharmacies

President Barack Obama signed into law new legislation that gives the Food and Drug Administration (FDA) more regulatory control over compounding pharmacies. The move comes 15 months after authorities linked a multistate fungal meningitis outbreak to contaminated steroid shots manufactured and distributed by a Massachusetts-based specialty pharmacy. The new law does not give the FDA as much control over compounding pharmacies as the agency had hoped, but it does give FDA the authority to conduct on-site inspections of pharmacies that mass produce custom-mixed drugs for distribution across state lines. The FDA oversees drug companies that produce pharmaceuticals and over-the-counter medicines. ... Read More

Compounding pharmacy’s insurance company claims it does not owe victims of fungal meningitis outbreak

The insurance company for Ameridose, the parent company of the compounding pharmacy blamed for producing and distributing contaminated steroid shots that led to a multistate fungal meningitis outbreak, is asking a federal judge to declare that a $5 million insurance policy cannot be used to pay victims’ claims. The outbreak sickened at least 750 people with fungal infections including fungal meningitis, and killed 64. Treatment for the infections involve months of antifungal medication with grueling side effects. One patient who had recovered from a related infection has suffered a relapse, sending a wave of unrest to those who assumed they ... Read More

Fungal meningitis victim suffers re-occurrence, raises new concerns for health officials

The deadly fungal meningitis outbreak stemming from contaminated steroid shots made by a compounding pharmacy continues to wreak havoc on its victims. Saint Thomas West Hospital in Nashville announced that a patient was admitted last week after suffering a re-occurrence of fungal infection. New England Compounding Center (NECC) had distributed about 18,000 contaminated steroid shots to medical centers across the country between late May and late September 2012. The shots are commonly used to treat neck, back or joint pain. An estimated 14,000 people received the injections before the drugs were recalled. Since then, at least 750 people have been sickened and ... Read More

New bill aims to stiffen federal oversight of compounding pharmacies

One year after a multistate fungal meningitis outbreak linked to contaminated steroid shots manufactured by a compounding pharmacy, Congress is considering legislation that will clarify the Food and Drug Administration’s (FDA) role in the oversight of large-operation compounding pharmacies that act much like drug manufacturers. Compounding pharmacies custom-mix FDA-approved drug ingredients according to a physician’s prescription generally on a per patient basis. Pharmacies are currently regulated by state pharmacy boards. Comparatively, the FDA oversees drug companies that manufacture drugs. However, some compounding pharmacies have started mass-producing these custom drugs and shipping them to medical facilities across state lines, which has raised ... Read More

Compounding pharmacy issues recall of prescription vitamin products

A Food and Drug Administration (FDA) inspection of a compounding pharmacy laboratory has resulted in a recall of B12 and neonatal vitamins to the consumer level. Park Pharmacy & Compounding Center is recalling two lots of Methylocobalamin (5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013) and Multitrace-5 Concentrate (10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection) after FDA inspectors observed methods used by the laboratory to assess the sterility of the products may have resulted in pharmacies receiving inaccurate laboratory test results. The agency is concerned that the results obtained from the laboratory are not reliable. The prescription preparations ... Read More

Bacterial infections linked to drugs made by Texas compounding pharmacy

At least 15 people have fallen ill with bacterial infections after receiving intravenous infusions of a drug manufactured by Specialty Compounding pharmacy in Cedar Park, Texas. As a precaution, the pharmacy is recalling all sterile products that have been dispensed since May 9, 2013. All the patients received calcium gluconate infusions and later developed infections caused by Rhodococcus bacteria. The infection can cause fever and pain. Calcium gluconate is a drug used to treat patients with calcium deficiencies and those with excessive potassium in their blood. The affected patients received the injections at one of two Texas hospitals – Corpus Christi ... Read More

Another compounding pharmacy recalls all products due to sterility issues

All sterile products made by Beacon Hill Medical Pharmacy d/b/a Rxtra Solutions, a compounding pharmacy in Southfield, Mich., have been recalled because the Food and Drug Administration (FDA) has raised questions about the sterility of the products. Microbial contamination of products that are intended to be sterile can cause serious infections that can be life threatening. To date, there have been no reports made to Beacon Hill of any adverse reactions related to the recall, nor has any evidence of contamination been found in the recalled products or any products previously prepared by the pharmacy. The recall affects more than ... Read More

Life threatening liver damage, adrenal gland problems, harmful drug interactions with anti-fungal drug

The Food and Drug Administration (FDA) is taking several actions to limit the use of the oral, anti-fungal medication Nizoral (ketoconazole) tablets, warning that the drug can cause potentially fatal liver injuries and adrenal gland problems, and advising that it can have harmful interactions with other medications. The FDA is advising that Nizoral oral tablets not be a first-line treatment for fungal infections. The drug should be used for certain fungal infections, known as endemic mycoses, only when alternative anti-fungal therapies are not available or tolerated by the patient. Nizoral tablets are indicated for the following systemic fungal infections: candidiasis, chronic ... Read More