Wednesday, December 12, 2012
Framingham's Congressman Edward Markey pushes the FDA for action, after workers, customers report serious health impacts from exposure to formaldehyde in hair straightening products.
Framingham's U.S. Rep. Ed Markey wants the U.S. Food and Drug Administration to investigate hair straightening treatments, including the Brazilian Blowout. Markey, along with democratic congressmen from Oregon and Illinois, sent a letter to Food & Drug Administration Commissioner Margaret Hamburg Tuesday urging the agency to protect salon workers and consumers from these straightening treatments which contain formaldehyde. Formaldehyde has been classified as a known human carcinogen (cancer-causing substance) by the International Agency for Research on Cancer and as a human carcinogen by the U.S. Environmental Protection Agency, in amounts that exceeds FDA guidelines. Across America, complaints have been reported by hair salon workers and…
Tuesday, December 4, 2012
As there is the possibility the tainted drugs could cause illness, federal health officials recommend doctors and other health care providers be alert for signs of fungal infection in patients who received these additional NECC medications.
As part of the ongoing investigation of the deadly, national outbreak of fungal meningitis the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been continuing to test products produced at Framingham-based New England Compounding Center. Monday, the two federal health agencies released a new report, which identified products beyond the original steroids, that contained fungi and bacteria. Federal health officials stressed there’s no evidence the new drugs have caused any additional outbreaks of fungal meningitis or any other illnesses. Nationally, 36 people have died and more than 510 infected with fungal meningitis linked to NECC. Monday, CDC and FDA said they have identified additional …
Saturday, November 17, 2012
Federal health officials and New England Compounding Center have insisted none of the contaminated steroids were distributed in Massachusetts; this could mean other shipments may have been contaminated
State and federal health officials are investigating whether a Massachusetts woman contracted fungal meningitis after receiving steroid shots manufactured by New England Compounding Center, the Framingham specialty pharmacy at the center of a national fungal meningitis outbreak. Nationwide, 33 people are dead, and more than 475 individuals are infected with fungal meningitis in 19 states. The Andover woman, 71, received shots for back pain in August, September, and on Oct. 1 at the Merrimack Valley Pain Management Associates in Lawrence, her attorney, Peter G. McGrath told Boston.com. “Around Oct. 23rd, she became terribly ill, was rushed to the hospital suffering headaches, body aches, fever and all the classic symptoms for meningitis,” …
Wednesday, November 14, 2012
Subpoenaed to appear before lawmakers is Barry Cadden, managing pharmacist of New England Compounding Center of Framingham.
Two congressional committees will hold hearings Wednesday and Thursday as part of an investigation into the fungal meningitis outbreak that has killed 32 patients and infected more than 435 individuals in 19 states. At the center of the investigation is New England Compounding Center (NECC) on Waverly St. The Framingham specialty pharamacy has had its license revoked in Massachusetts. The FDA, following a raid, said it discovered unsetrile conditions. A subcommittee of the House Energy and Commerce Committee is slated to hear testimony from Food and Drug Administration Commissioner Margaret Hamburg today, Nov. 14. Also subpoenaed to appear is Barry Cadden, managing pharmacist of NECC, which manufactured and distributed the tainted steroids…
Monday, November 12, 2012
Ameridose responded to the findings in a statement.
Federal Food and Drug Administration inspectors saw insects and a bird while inspecting Ameridose, a Westborough facility that shares owners with the Framingham specialty phramcy connected to a national meningitis outbreak, WCVB reported today. The insects were seen "within 10 feet of a supposedly sterile area where drugs are manufactured," WCVB reported. "In another case, inspectors reported a bird flying into a room where drugs are stored." Ameridose responded to the findings in a statement. “We have received the FDA’s written observations included in their Form 483 that is based on a comprehensive 30-day review of our facilities and our processes, conducted by more than 20 inspectors representing both state and federal agencies," the …
Friday, November 2, 2012
The pharmacy says the move expands its cooperation with the FDA.
UPDATE, 3:30 p.m. Nov. 2: Ameridose, the Westborough facility that shares owners with the Framingham company connected to a national meningitis outbreak, will be closed until at least Nov. 19. The temporary closure of Ameridose LLC, by mutual agreement with state regulators, was extended to give investigators more time to inspect the facility, the Boston Globe reported. ORIGINAL STORY: The Boston Globe reports that Ameridose voluntarily has recalled all of its drugs following an ongoing FDA inspection of the Westborough facility. In a press release today, Ameridose officials said the recall "represents an expansion of our cooperation with the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy." "…
Friday, October 26, 2012
The Framingham facility is at the center of a deadly meningitis outbreak.
The FDA has issued a copy of the FDA Form 483, which found problems with New England Compounding Center. The FDA cited a problem as the Framingham company's “ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination.” In a press release, the FDA reported: Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container. The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices …
Thursday, October 25, 2012
The FDA list includes all customers of the Framingham specialty pharmacy and not just those who received the steroids, which have been linked to a deadly meningitis outbreak.
The Federal Drug Administration has released a list of customers, who received products from New England Compounding Center in Framingham on or after May 21. The list does not identify what products the customers received. New England Compounding Center (NECC) recalled more than 17,000 steroids in September indictaing they may contain a fungus. The fungus has been linked to a deadly meningitis outbreak that has infected more than 300 in 17 states and killed 23 individuals. NECC has maintained the steroids were not distributed in Framingham or Massachusetts. Over Columbus Day weekend, NECC recalled all of its 1,200 products. For a list, click here. This new list by the FDA indicates which health care facilities and hospitals received any …
Wednesday, October 24, 2012
"it is hard to imagine that the (Massachusetts) Board (Of Registry in Phramacy) has not been fully apprised of both the manner and scale of the company’s operations," said New England Compounding Center's counsel in a statement.
Gov. Deval Patrick, in a press conference Tuesday, announced New England Compounding Center has had its pharmacy license permanently revoked and will be the subject of a federal criminal investigation. He said the Framingham company will never practice again in Massachusetts. The Framingham company has been at the center of a deadly national meningitis outbreak. Federal health officials say more than 300 people have been infected with fungal meningitis, in 17 states, and 23 are dead. Health officials have tied a steroid produced by the Waverly Street company to the fungal meningitis outbreak. Tuesday evening, NECC, through it's attorney, released a statement. "NECC has had a long standing practice of working closely and cooperatively with …
Tuesday, October 23, 2012
Congressman Ed Markey told Framingham Patch a law is needed to ensure compounding pharmacies don't turn into compounding manufacturers.
Congressman Ed Markey (D-Malden), in Framingham Monday to celebrate the opening of a biomedical manufacturing plant, spoke a few minutes to Framingham Patch about the deadly meningitis outbreak, linked to tainted steroids produced at New England Compounding Center in Framingham. The Centers for Disease Control now says almost 300 people have been infected with fungal meningitis in 16 states, including 23 deaths. Markey, who represents Framingham, is the senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA). He said NECC fell into a "blackhole" between federal and state regulators and became a "compounding manufacturer" and not a compounding pharmacy.