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steroid shots 39 articles

NIH shuts down drug making processes after vials found tainted with fungus

The National Institutes of Health (NIH) has suspended all drug making practices and halted clinical trials using products made at its facility after federal regulators discovered some of the products were contaminated with fungus. Six patients who reportedly received the tainted meds are being watched for any adverse effects. “This is a distressing and unacceptable situation,” said NIH Director Dr. Francis Collins, who expressed concern for putting patients in “harms way because of a failure to follow standard operating procedures.” NIH is a biomedical research facility primarly located in Bethesda, Md. It is an agency of the U.S. Department of ... 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

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 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

Pharmacy records from medical clinics subpoenaed for fungal meningitis outbreak investigation

Pharmacy records from three Tennessee medical clinics have been subpoenaed as part of a legal investigation into deaths and injuries allegedly caused by contaminated steroids shots manufactured by New England Compounding Center (NECC) based in Framingham, Mass. The subpoenas were sent to St. Thomas Outpatient Neurological Center in Nashville, Specialty Surgery Center in Crossville, and PCA Pain Center in Oak Ridge. The records were requested by attorneys representing patients in a consolidated federal lawsuit against the compounding pharmacy that made the shots. The documents requested include records between the clinics and NECC that would detail purchases, quantities, pricing and dates. NECC manufactured ... Read More

FDA identifies fungus, bacteria in steroid shots made by Tenn. pharmacy

Federal investigators have identified bacterial and fungal growth in two unopened steroid injections used by medical facilities to treat back or joint pain, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn. The vials of preservative-free methylprednisolone acetate (MPA) are the same type of compound that has sickened at least 745 people with fungal infections including fungal meningitis, and killed 58. Those injections were compounded by New England Compounding Center, a Massachusetts-based pharmacy. To date, seven infections, none of which appear to be meningitis, but no deaths have been reported in patients who received the Main Street ... Read More

Potentially contaminated steroid shots from Tenn. pharmacy distributed to 13 states

Seven people in Illinois and North Carolina have developed “adverse effects” after receiving steroid shots from a Tennessee compounding pharmacy. The injections, used to treat neck, back or joint pain, are the same drugs as those compounded by New England Compounding Center (NECC) that were identified as the culprit in the multistate fungal meningitis outbreak that – to date – has killed 58 people and sickened 745 with fungal infections including fungal meningitis. The facility where the shots were manufactured was later found a sterility risk. Main Street Family Pharmacy, located in Newbern, Tenn., distributed the injections of methylprednisolone acetate, or MPA, to ... Read More