Tag: FDA

Posted on

Garrett Calls on FDA to Answer Questions About EpiPen Monopoly

Epi-pen

September 24,2016
the staff of the Ridgewood bog

Ridgewood NJ, Rep. Scott Garrett (NJ-05) called on the Food and Drug Administration (FDA) to express concerns over the near monopoly currently held by Mylan Pharmaceuticals on the EpiPen (epinephrine injection) which is used in the treatment of severe allergic reactions. The price of these life-saving devices has skyrocketed recently, making them unaffordable for many Americans families.

“Like many government bureaucracies, the Food and Drug Administration stifles innovation and creates unnecessary roadblocks that end up hurting the American people,” said Garrett. “In this case, their short-sightedness has made a common treatment that millions of Americans rely on prohibitively expensive. The FDA has a job to protect Americans and ensure the food and drugs we use are safe, but they also need to make sure their actions don’t hurt the very people they’re trying to protect.”

The letter, signed by a number of Members of Congress, asks the EPA to allow other companies to make alternatives to the EpiPen product by streamlining the FDA review process. Specifically, the letter asks:

–          If the FDA can clarify whether any barriers exist to the approval of safe alternative products to EpiPens.

–          How many alternatives to Mylan’s EpiPen are currently being reviewed by the FDA

–          Where these alternatives are in the review process

To read the entire letter, click here.

 

Posted on

FDA Orders Antibacterials Removed From Consumer Soaps

The Robot from Lost In Space

by MAGGIE FOX

Say goodbye to those “antibacterial” soaps. The Food and Drug Administration says they do little or nothing to make soap work any better and said the industry has failed to prove they’re safe.

Companies will have a year to take the ingredients out of the products, the FDA said. They include triclosan and triclocarban. Soap manufacturers will have an extra year to negotiate over other, less commonly used ingredients such as benzalkonium chloride.

“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” the FDA said in a statement.

https://www.nbcnews.com/health/health-news/fda-orders-antibacterials-removed-consumer-soaps-n642036

Posted on

Woman suing The Valley Hospital dies

Valley_Hospital_theridgewoodblog

SEPTEMBER 12, 2015    LAST UPDATED: SATURDAY, SEPTEMBER 12, 2015, 1:21 AM
BY LINDY WASHBURN
STAFF WRITER |
THE RECORD

A woman who sued The Valley Hospital, her doctors and the maker of a medical device that she claimed caused the spread of her cancer has died, just days after providing videotaped testimony to be used when her lawsuit comes to trial.

Viviana Ruscitto, a radiology administrator and the mother of a 2-year-old boy, was 43.

Ruscitto was diagnosed with metastatic leiomyosarcoma, a rare and aggressive cancer, a few weeks after undergoing surgery for uterine fibroids at the Ridgewood hospital last October.

During the minimally invasive procedure, a device known as a laparoscopic power morcellator was used to shred and grind the tissue to be removed so that the fragments could be sucked out through a small incision.

The morcellator’s spinning blade disperses particles from the shredded tissue throughout the abdomen and enables some cells to be absorbed and transported by the lymph system.

The federal Food and Drug Administration recently said that 1 in every 350 women who undergoes a hysterectomy for fibroids has a cancer that may not have been detected but would be spread through morcellation.

https://www.northjersey.com/counties/woman-suing-hospital-dies-1.1408599

Posted on

Dying woman sues her New Jersey doctors for using a hysterectomy device that the FDA says can spread cancer

Vally_Hospital_theridgewoodblog

BY ASHLEY LEWIS
NEW YORK DAILY NEWS

Friday, August 14, 2015, 6:08 PM

A 43-year-old New Jersey mother is lying on her death bed, her body racked with cancer a year after she underwent a hysterectomy, and she’s blaming her doctor for using a controversial device in the procedure.

Viviana Ruscitto is suing her oncologist, Dr. Howard Jones, for malpractice, alleging he used a device that she blames for spreading cancer cells in her uterus throughout her internal organs.

“My sister’s prognosis is poor, and I do not know how much longer she can continue fighting this cancer,” Mirian Riviera told a judge last week in a sworn statement.

Ruscitto had a minimally invasive hysterectomy performed in October 2014 to remove a large fibroid in her uterus at The Valley Hospital in Ridgewood, N.J.,The Record reported.

Jones used a controversial surgical tool, a power morcellator, to cut and tear tissue so it could be removed from her body.

The device was approved to remove uterine fibroids in 1991 because the small incisions from morcellation helped patients recover quicker and easier.

The device has come under heavy scrutiny in recent years, however, and in April 2014 the FDA released a safety alert against morcellators, acknowledging that the device can spread undetected cancer cells.

The agency said some of the minced undetected cancerous tissue fragments could be left behind in the abdominal cavity and spread to other parts of the body.

The government discouraged doctors from using the morcellators and encouraged professionals to discuss the risks and benefits with their patients.

The device’s largest manufacturer, Ethicon, a division of Johnson & Johnson, promptly pulled the morcellator off the market.

 

https://www.nydailynews.com/news/national/woman-sues-doctors-controversial-hysterectomy-device-article-1.2326455