Navigation Links
FDA: More Tainted Products at Firm Tied to Meningitis Outbreak

By Steven Reinberg and Margaret Steele
HealthDay Reporters

FRIDAY, Nov. 2 (HealthDay News) -- Lab tests have found bacteria in two other medical products made by the Massachusetts-based specialty pharmacy at the center of the ongoing fungal meningitis outbreak, U.S. Food and Drug Administration officials said Thursday.

It's not yet clear just how dangerous the various bacteria found in three batches of a steroid used during eye surgery and one batch of a solution used to stop the heart during cardiac surgery might be, FDA officials said in a news release.

However, tests for fungal contamination in both products are pending and FDA officials reiterated their concern about the safety of any medical products made by the New England Compounding Center. Since the meningitis outbreak began more than a month ago, the company has recalled all of its medical products and shut down its manufacturing plant in Framingham.

Meanwhile, Massachusetts officials said Thursday that they had put emergency regulations in place that give the state greater control and scrutiny over specialty pharmacies such as the New England Compounding Center, the Boston Globe reported.

Under the new rules, the state can now track the volume and distribution of drugs made by these pharmacies to see if they should be subject to FDA licensing regulations, the Globe reported. Pharmacies that fail to follow the stricter state regulations will be subject to penalties that include being shut down or quarantined by the state pharmacy board. Specialty pharmacies will also have to report when they are being investigated by another state or federal agency, according to the Globe.

As of Friday, 29 people had died and 404 had been sickened in the fungal meningitis outbreak, federal health officials said.

The U.S. Centers for Disease Control and Prevention on Friday had the following state-by-state breakdown of cases: Florida: 23 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 2 cases; Indiana: 50 cases, including 3 deaths; Maryland: 23 cases, including 1 death; Michigan: 112 cases, including 7 deaths; Minnesota: 10 cases; New Hampshire: 11 cases; New Jersey: 21 cases; New York: 1 case; North Carolina: 3 cases, including 1 death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 2 cases; South Carolina: 1 case; Tennessee: 78 cases, including 12 deaths; Texas: 2 cases; Virginia: 46 cases, including 2 deaths.

Nine of the 404 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.

Meningitis is inflammation of the lining surrounding the brain and spinal cord. The steroid injections are used to treat pain in the lower back as well as joints.

Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the New England Compounding Center. All of the fungal meningitis patients identified so far were thought to be injected with methylprednisolone acetate, according to the CDC.

The New England Compounding Center is what's known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, but some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.

More information

The U.S. National Library of Medicine has more about injections for back pain.

SOURCES: Nov. 2, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Nov. 1, 2012, news release, U.S. Food and Drug Administration; Boston Globe

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Tainted Tattoo Ink Led to Skin Infection Outbreak
2. Researchers find evidence of banned antibiotics in poultry products
3. Pig stomach mucins are effective as anti-viral agents for consumer products
4. Probiotic Products May Prevent Antibiotic-Linked Diarrhea
5. Fieldtex Products Launches a New Wellness Rewards Service for Companies
6. Announces Beauty Products Under $30 Sale
7. Swanson Health Products Introduces a New Alkalizing Drink Mix, Swanson® pH Balance Alka-Tone with Alka-Plex™ Technology
8. The Biochar Company Partners with Hawaii Biochar Products
9. Law Firm Aggressively Litigating against Birth Control Makers for their Newer, but Allegedly Unsafer Products: Nuvaring, Yaz, BeYaz, Yasmin, Ocella, Gianvi
10. GTC Green Cleaning Products Now Available from UNFI - United Natural Foods
11. Chemicals in personal care products may increase risk of diabetes in women
Post Your Comments:
Related Image:
FDA: More Tainted Products at Firm Tied to Meningitis Outbreak
(Date:10/13/2017)... ... October 13, 2017 , ... Dickinson Insurance ... insurance and financial preparation services, is providing an update on a charitable event ... Rock City Rescue is a locally recognized nonprofit that provides shelter and care ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... their devotion to personalized service, SMP Pharmacy Solutions announces their ... South Florida Business Journal,s 50 Fastest-Growing Companies, and listed for ... specialty pharmacy has found its niche.  To that end, the ... by SFBJ as the 2017 Power Leader in Health Care. ... award in October, Bardisa said of the three achievements, "It,s ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/19/2017)... --  ZirMed Inc ., a recognized leader in cloud-based revenue ... been ranked #1 by its users for the seventh consecutive ... Survey. ZirMed was recognized as the top-ranked end-to-end revenue cycle ... over 200 beds and holds one of the longest #1 ... ...
Breaking Medicine Technology: