Drug manufacturers and pharmacies in the U.S.A. have recently been found to violate the rules and guidelines laid down by the U.S. Food and Drug Administration. On investigation, samples containing the steroid used to relieve back pain have been found that is supposed to be the cause of Fungal Meningitis. Preliminary investigations by the FDA revealed that contamination in the process of drugs manufacturing of steroid injections has caused a fungal meningitis outbreak from steroid back injections resulting in deaths and serious sickness according to the article below. Investigations also revealed non-sterilized pharmaceutical ingredients were being used for the manufacture of drugs.

Over 30 cases of fungal meningitis have been linked to a steroid treatment for back pain. ABC WorldNews Report.

Fungal Meningitis Outbreak From Steroid Back Injections

What should patients know about steroid back injections? Read in this article.

 
The Massachusetts pharmacy at the heart of a probe into a deadly meningitis outbreak may have violated federal health laws, U.S. Food and Drug Administration investigators said Friday, saying mold and bacteria were found in areas where drugs were mixed.

 

Cases of fungal meningitis have reached 28 states, including Maryland, where 19 people have been sickened and one has died. The report came as Maryland health officials criticized the oversight of “compounding” facilities like the one in Massachusetts, which make specialized drugs.

 

The FDA said it had uncovered 83 vials from the New England Compounding Center that contained the steroid linked to the outbreak; they contained a “greenish black foreign matter.” Seventeen other vials of the drug, methylprednisolone acetate, contained a threadlike white matter.

 

The findings were outlined Friday by the FDA in a report investigators issue when they find evidence that federal health laws may have been violated. The investigators also found potential contamination in other areas of the center where drugs weren’t directly handled.

 

Three lots of steroids from the company are linked to the meningitis outbreak that has killed 25 people and sickened 338.

 

The FDA declined to provide any broad analysis or conclusions from the findings because the investigation is not complete. The report does not have legal force and the investigation needs to be completed before a decision on any action against New England Compounding Center is made, said FDA official Paul Teitell.

 

New England Compounding Center officials said they are reviewing the FDA report.

 

“We will review this report and will continue our cooperation with the FDA,” the company said in statement. “We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”

 

The steroid implicated in the outbreak was used to ease back pain. About 1,500 people in Maryland are among the 13,000 nationwide possibly exposed to meningitis, an infection of the membranes that protect the brain and spinal cord.

 

FDA investigators said they found greenish-yellow discolorations and tarnished discoloration on sterilization devices at New England Compounding Center. The pharmacy also used nonsterile pharmaceutical ingredients to make drugs even though it said the raw materials it used were sterile, the report said.

 

New England Compounding Center’s monitoring also found contamination from January though September, including visible mold, according to the report.

 

The FDA report points out that a recycling facility that abuts the pharmacy handles mattresses and plastics, and contains large equipment that produces airborne particles. Rooftop air-conditioning units serving the pharmacy are about 100 feet from the recycling facility, the report said. FDA officials declined to say whether that could have been a source of the contamination.

 

The agency’s findings are similar to those from an investigation by the state of Massachusetts, which said the facility released drugs before determining whether they were sterile, issued drugs without a prescription and, in general, did not follow proper sterilization guidelines.

 

As more evidence of widespread contamination at New England Compounding Center has grown, the FDA has told medical facilities nationwide to discard any drugs sold by the facility after May 21, including those unrelated to the meningitis outbreak. Earlier this week, the agency listed more than 3,000 medical facilities that brought products from the company, including 89 in Maryland.

 

But Maryland health officials said most of the risk comes from the three lots of steroids.

 

The problems at New England Compounding Center have raised questions about the regulation of compounding pharmacies, which make specialized drugs that cannot be found or are in short supply commercially. Many are small operations, but some have grown into large manufacturers.

 

Compounding facilities are regulated by state boards, but many are questioning whether the FDA should regulate the pharmacies because they behave more like large drug manufacturers.

 

The critical article written by Sharfstein and two other officials points out that the compounding pharmacy industry boasts about technology paving the way for more pharmacies to customize medications.

 

“The debacle at the New England Compounding Center, however, indicates that compounding has yet to fully emerge from the Dark Ages,” the article reads. “All compounding pharmacies must take responsibility for the quality of what they produce.”

 

read more of the article here

 

The fungal meningitis outbreak from steroid back injections is currently being investigated. It appears to be due to a contaminated drug manufacturing process in which steroids for back pain relief having been found to be used. The FDA has instructed all medical facilities in the U.S. not to use the injections manufactured after May 21. Questions have been raised about the regulatory guidelines for pharmacies that are engaged in the manufacture of rare drugs.
 
Although compounding pharmacies regulated by the State Board boast about using the latest technology, it is suggested that the FDA take over the monitoring of compounding pharmacies because they have been operating inappropriately. These questions have been raised due to non-sterilized pharmaceutical ingredients were used in drug manufacture. The risks come from the three vials of steroids found in the New England Compounding Center, which have posed a danger to society. As a result, an outbreak of Meningitis has caused a death and serious illness. The responsibilities lie with the compounding pharmacies to produce quality drugs rather than be so dangerous as to kill rather than cure you.

Attorney Anthony Castelli discusses 5 things you need to know about the meningitis outbreak