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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

FDA warns of serious risks associated with epidural injections of corticosteroids

Injections of corticosteroids into the epidural space of the spine may cause rare but serious side effects including vision loss, stroke, paralysis and death, the Food and Drug Administration (FDA) warned. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. However, the effectiveness and safety of epidural administration of corticosteroids has not been established and the FDA has not approved corticosteroids for this use. The agency is requiring warnings be placed on the safety labels of injectable corticosteroids to explain these risks to health care providers and patients. While the FDA ... 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

FDA proposes stricter guidelines for widely prescribed painkiller hydrocodone

Proposed new guidelines for painkillers aims to put drugs containing hydrocodone, such as Lortab and Vicodin, in the same category as potent opioids like Oxycontin and morphine. The Food and Drug Administration’s (FDA) recommendation for the highly addictive class of painkillers must first be approved by other Health and Human Service Department officials before it can go into effect. The major policy change comes more than a decade after the Drug Enforcement Administration (DEA) first asked that hydrocodone-containing drugs be more restricted. Hydrocodone drugs are the most widely prescribed medications in the country, with more than 131 million prescriptions written ... 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

Texas woman files lawsuit against makers of Mirena IUD

Rachel Coe had no idea the injuries she could suffer from her Mirena interuterine device (IUD) when she received one in 2006 to prevent pregnancy. The insertion of the device was uncomplicated and properly placed, her physician said. However, something went frightfully wrong. Rachel began to suffer from fatigue, abdominal and pelvic pain, abnormal bleeding, ovarian cysts, urinary incontinence and other issues. She returned to her doctor in 2008, who could not locate the IUD by digital examination, nor could she locate the device during two subsequent ultrasounds. Two years later, Rachel sought treatment for her symptoms at a hospital ... 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

Mirena IUD side effect lawsuits expected to grow into hundreds

Sarah says her experience with Mirena IUD for birth control was so horrendous that she would never recommend the device to anyone. The mother of three says she felt pain the minute the intrauterine device was inserted. The pain got so bad she went to the emergency room where doctors told her she would have to have her IUD removed as soon as possible. The device had perforated her uterus and floated into her abdomen. She had to undergo surgery to remove it. It was a frightening experience, but one that is being reported more and more with the T-shaped, ... 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