Navigation Links
Congress to Open Hearings Into Steroid/Meningitis Outbreak
Date:11/13/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

TUESDAY, Nov. 13 (HealthDay News) -- Congress will open hearings this week into the fungal meningitis outbreak linked to tainted steroid injections that has killed 32 people so far and sickened 438 others.

On Wednesday, a subcommittee of the House Committee on Energy and Commerce will hold a hearing titled "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"

And on Thursday, U.S. Food and Drug Administration Commissioner Margaret Hamburg is scheduled to testify before the Senate Committee on Health, Education, Labor, and Pensions for a hearing, "Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak."

A Massachusetts specialty -- or "compounding" -- pharmacy is the suspected source of the tainted steroid injections, which are typically used for back and joint pain. The New England Compounding Center, in Framingham, has ceased operations since the meningitis outbreak first surfaced last month.

Compounding pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such custom-made 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. But some members of Congress now say the meningitis outbreak underscores the need for more regulatory control.

Meningitis is inflammation of the lining surrounding the brain and spinal cord. Infected patients have developed a range of symptoms approximately one to four weeks following their injection.

Massachusetts officials said earlier this month they had put emergency regulations in place that give the state greater control and scrutiny over specialty pharmacies like the New England Compounding Center.

Late last month, FDA investigators who toured the Framingham plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, federal health officials said. The contaminated product was one of a host of potential violations discovered during the recent inspection, the officials said.

"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during an Oct. 26 news conference.

In addition, the company couldn't prove that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.

The FDA also found that the company wasn't able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.

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: 52 cases, including 4 deaths; Maryland: 23 cases, including 1 death; Michigan: 128 cases, including 7 deaths; Minnesota: 11 cases; New Hampshire: 13 cases; New Jersey: 27 cases; New York: 1 case; North Carolina: 3 cases, including 1 death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 3 cases; South Carolina: 1 case; Tennessee: 81 cases, including 13 deaths; Texas: 2 cases; Virginia: 50 cases, including 2 deaths.

Ten of the 438 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.

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 the steroid methylprednisolone acetate, according to the CDC.

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.

More information

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

SOURCES: Nov. 13, 2012, news release, U.S. Food and Drug Administration; Nov. 9, 2012, updated statistics, U.S. Centers for Disease Control and Prevention


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Latest coffee and health research to be debated at the World Congress on Prevention of Diabetes
2. CONRAD to host HIV symposium at 2nd Annual Antivirals Congress
3. ESMO 2012 Congress: Press conference schedule
4. ACP urges Congress to halt across-the-board sequestration cuts in health programs
5. ESMO 2012 Congress: Program preview
6. New data on pPCI rates to be launched at ESC Congress 2012
7. New heart attack definition to be launched at ESC Congress 2012 topics: Myocardial disease
8. Healthcare researchers recognized at SingHealth Duke-NUS Scientific Congress 2012
9. Defining tomorrows medicine - SingHealth Duke-NUS Scientific Congress 2012
10. Pediatric kidney expert receives Young Investigator Award from American Transplant Congress
11. ESC Congress 2012 media alert
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Congress to Open Hearings Into Steroid/Meningitis Outbreak
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, ... The purpose of these scholarships is to encourage applicants to pursue a degree ... employment within these two parishes. , “We have available jobs in St. Landry ...
(Date:2/12/2016)... VA (PRWEB) , ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to ... , As Winston Churchill said, “Those who don’t learn from history ... show what to expect when they come knocking this year. But that takes time. ...
(Date:2/12/2016)... Angeles, CA (PRWEB) , ... February 12, 2016 , ... ... With a hectic schedule, a demanding job, and no time to decompress, Rabinowitz found ... she dedicated herself to meditation for its impact on her life, implementing a 20-minute-per-day ...
(Date:2/12/2016)... Appleton, Wis. (PRWEB) , ... February 12, 2016 ... ... its second Lean Leadership Series at Zuckerberg San Francisco General Hospital on April ... to practice new behaviors and create new habits. The workshops cover a broad ...
(Date:2/12/2016)... ... February 12, 2016 , ... Fisher House Foundation Chairman ... John J. Lee, Nevada Military Support Alliance president Scott Bensing, and Peggy Kearns Director, ... VA Southern Nevada Healthcare System. This will be the first Fisher House in ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... N.J. , Feb. 12, 2016  Innophos Holdings, Inc. ... and nutritional specialty ingredients, today announced that it will host ... 10:00 am ET to discuss its fourth quarter and full ... --> The press release detailing fourth quarter and full ... after market close. --> ...
(Date:2/12/2016)... 2016 (Kanadische ... http://www.sedar.com ) und der Website ... --> http://www.sedar.com ) und ... abrufbar.    --> Telesta ... Konzernabschluss des zweiten Quartals und die ...
(Date:2/12/2016)... JOSE, Calif. , Feb. 12, 2016  SI-BONE, Inc., a ... System ® ("iFuse"), a minimally invasive surgical (MIS) device indicated ... that National Government Services, Inc. (NGS), the Medicare Administrative Contractor (MAC) ... Illinois , Maine , Massachusetts ... , New York , Rhode ...
Breaking Medicine Technology: