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fungal infections 46 articles

Another compounding pharmacy recalls all products after contaminant found in several drug compounds

Once again, the Food and Drug Administration (FDA) is ordering the recall of all sterile products manufactured by a compounding pharmacy, this time because visible particles were seen floating in several different compounds. The FDA says the potential health risks are unknown at this point because the contaminant is as yet unidentified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material. The recall was ordered on all sterile products made by Pallimed Solutions, Inc., based in Woodburn, Mass., which does business as ... Read More

Compounding pharmacy recalls products due to mold contamination

Med Prep Consulting, Inc., a compounding pharmacy based in Tinton Falls, NJ, is recalling all products after mold was discovered floating in plastic infusion bags. The mold was discovered in five bags of magnesium sulfate 2GM in Dextrose 5% in water, 50ml for injection, a product used for magnesium electrolyte replacement. If an intravenous product found to contain mold is injected into a patient, it could have deadly results. In an abundance of caution, Med Prep Consulting has recalled all products compounded by the pharmacy due to lack of sterility assurance. The affected products are administered for a wide range ... Read More

CDC urges doctors to remain vigilant for fungal infections in patients who received tainted steroid shots

The Centers for Disease Control and Prevention (CDC) is urging health care professionals to use continued vigilance for fungal infections among patients who received contaminated steroid shots from New England Compounding Center (NECC). The CDC continues to receive new reports of fungal infection among patients who were given injections of contaminated methylprednisolone acetate (MPA) from NECC. The fungal infections are part of the deadly multistate fungal meningitis outbreak that, to date, has killed 48 people and sickened at least 720 with meningitis, spinal infections, strokes and peripheral joint infections. All patients received steroid shots for back or joint pain that ... Read More

Indiana Board of Pharmacy revokes license of pharmacy blamed for meningitis outbreak

The Indiana Board of Pharmacy has revoked the license of New England Compounding Center (NECC), the Massachusetts-based specialty pharmacy that produced and distributed nationwide contaminated steroid shots tied to a deadly fungal meningitis outbreak. NECC will not be allowed to operate in Indiana for at least seven years. The Indiana Attorney General’s office said in a statement that the action was a necessary step to ensure that NECC “which put patients unnecessarily at risk, does not operate within our state’s borders going forward.” After seven years, NECC will be able to apply for a new license, but the Indiana Board ... Read More

Fungal meningitis outbreak victim files lawsuit against Nashville medical facility

Victims of the deadly meningitis outbreak tied to steroid shots mass produced by New England Compounding Center (NECC) and distributed to medical facilities across the country are now aiming their lawsuits at bigger fish than the pharmacy in question. To date, two multimillion-dollar lawsuits have been filed against Saint Thomas Neurosurgery Center in Nashville, Tenn., one of the hundreds of facilities that received the tainted shots. NECC distributed three lots – or about 18,000 – steroid shots that were found to be contaminated with fungus. The shots are commonly used to treat back, neck or joint pain. An estimated 14,000 patients ... Read More

Attorneys seek to freeze assets of owners of compounding pharmacy blamed for meningitis outbreak

The compounding pharmacy blamed for mixing and distributing contaminated steroid shots that have killed dozens of people and sickened hundreds more paid out more than $70 million to company insiders since 2006, attorneys for creditors of the pharmacy said. The disclosure was made at a U.S. Bankruptcy Court hearing during which the creditors’ attorneys argued that creditors should be allowed to seek to freeze the assets of the pharmacy’s owners. New England Compounding Center (NECC) paid its four owners or companies they owned $70.5 million during the past six years. The motion was granted and a hearing is currently underway ... Read More

Owners of pharmacy blamed for fungal meningits outbreak received $16 million in payouts last year

The owners of New England Compounding Center (NECC), the specialty pharmacy accused of mixing and distributing contaminated steroid shots that created a multistate fungal meningitis outbreak that has killed dozens of people and sickened hundreds more, received more than $16 million in wages and profits last year. The pharmacy was investigated last fall at the height of the outbreak, and in October all operations ceased. The company filed for Chapter 11 bankruptcy just before the end of 2012. NECC faces hundreds of lawsuits from people or their family members who received the tainted shots. In documents filed in U.S. Bankruptcy ... Read More

Experimental diabetes drug tied to heart attacks, strokes, death

An increased risk of heart attacks, strokes and deaths may hurt the chances of Johnson & Johnson’s experimental diabetes drug canagliflozin being approved by the Food and Drug Administration (FDA). Data from nine large patient studies showed the drug raised levels of LDL, or bad cholesterol, and slightly increased risk of cardiovascular events or death compared to two other types of diabetes medications. The drug was also tied to urinary tract infections and fungal infections in the genital area, likely because the drug works by increasing the amount of sugar excreted in the urine, and germs thrive on that sugar. ... Read More

Compounding pharmacy blaming tainted steroid shots on cleaning service

New England Compounding Center (NECC), the specialty pharmacy a the center of the multistate fungal meningitis outbreak that has sickened more than 650 people and killed 39, is hoping to pass blame for the contaminated steroid shots it mixed on its cleaning service. Attorneys for NECC have sent a letter to UniFirst Corp., demanding that it take legal responsibility for claims against the pharmacy. UniFirst acknowledges that one of its subsidiaries helped clean portions of the pharmacy’s cleanroom where drug cocktails were mixed to doctors’ orders, but says its services were limited and that it could not be held liable ... Read More

Fungal meningitis outbreak could have been much worse if not for fast-acting health officials

Dr. Rachel Smith was immediately concerned when she got a call last September from the Tennessee Department of Public Health informing her that a patient at a pain clinic there had a very rare type of fungal meningitis. A fungal diseases expert with the Centers for Disease Control and Prevention (CDC), Smith first speculated that the infection might be caused by unsterile needles at the clinic where the patient was treated. Investigators quickly deduced that the source of the contamination was steroid shots given for back or neck pain. It was the first clue Smith had that a national emergency ... Read More