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methylprednisolone

The CDC has published a list of clinics that received shipments of Methylprednisolone Acetate, which was recalled on 26 September.

Find here the full list of healthcare facilities that received three recalled lots of Methylprednisolone Acetate (PF) from New England Compounding Center on September 26, 2012.

 

Investigators in the US have raided the premises of Massachusetts pharmaceutical company New England Compounding Center (NECC) linked to fungal meningitis outbreak.

The Food and Drug Administration (FDA) raised concerns about sterility and cleanliness at the NECC.

So far 16 people have died from a rare fungal form of meningitis, apparently after using contaminated drugs.

More than 200 people in 15 US states have been affected.

Steroids and heart drugs produced by the Boston-based NECC are under investigation and the FDA has warned doctors not to prescribe any of the company’s products.

Meningitis is an inflammation of the membranes covering the brain and spinal cord. Symptoms include severe headache, nausea and fever as well as slurred speech and difficulty walking.

Fungal meningitis is not contagious, according to US health officials.

Criminal investigators from the FDA searched the NECC premises on Tuesday as part of a broad state and federal investigation into the deadly outbreak.

Paul Cirel, a lawyer for the pharmaceutical company, told Associated Press that it was “difficult to understand the purpose” of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.

They have been several calls by US congressmen for a full-scale criminal investigation into the NECC’s practices.

The outbreak has raised questions about the practice of drug compounding, where pharmacies prepare specialized doses of medication. Compounding is not regulated by the FDA, which generally oversees drug makers.

NECC has suspended operations and recalled the steroid injection initially linked with the outbreak, methylprednisolone.

The FDA says it is looking into reports of a patient with possible meningitis who received an injection of triamcinolone, a different steroid, from NECC.

Two transplant patients also developed a fungal infection after receiving an unnamed heart drug made by the firm.

The FDA has not confirmed that these three infections were caused by NECC products, and has said that it is very possible that the heart patients were infected by another source.

On Monday, the drug regulator expanded its recommendation for doctors to warn anyone who received any injection made by the company, including drugs used in eye surgery.

Last week, health officials said 12,000 of the roughly 14,000 people in 23 states who received the steroid shots had been contacted.

The CDC has published a list of clinics that received shipments of the drug, which was recalled on 26 September.

Drug compounding:

• Drug compounding is used to make unique drugs for individual patients when there are no existing licensed treatments

• It is common practice around the world to make medicines for rarer conditions and children, for example

• Individual pharmacists or specialist drug companies combine, mix, or alter ingredients to create medications to meet these specific needs

• In the US, compounded drugs are not approved by the regulator the FDA, which means their safety and efficacy are unverified

• Poor practices on the part of drug compounders can result in contamination or in products that don’t possess the strength, quality and purity required

 

The US Centers for Disease Control (CDC) say 15 people have now died from an outbreak of fungal meningitis linked to steroid injections to treat back pain.

CDC said the latest death occurred in Indiana – the second in the state.

In all, nearly 200 people in 13 US states have been affected.

A company in Massachusetts earlier recalled more than 17,000 vials of steroid it had sent to more than 70 clinics across America.

Thirteen states have been affected: Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Illinois, Idaho and Texas.

Fungal meningitis is not contagious, the CDC says.

Meningitis is an inflammation of the membranes covering the brain and spinal cord. Symptoms include severe headache, nausea and fever as well as slurred speech and difficulty walking.

The drugs have been traced to Massachusetts’ New England Compounding Center.

The drug manufacturer last week voluntarily recalled all products in circulation that were made at its Framingham facility.

Massachusetts health regulators have said there were complaints against the pharmaceutical company in 2002 and 2003.

According to the Massachusetts Health Department, 17,676 vials of the steroid methylprednisolone acetate were sent to 76 healthcare providers in 23 states between July and September.

The CDC has published a list of clinics that received shipments of the drug, which was recalled on 26 September.

 

An outbreak of rare fungal meningitis in the US has now affected 47 people in seven states, Center for Disease Control (DCD) officials say.

Doctors at about 75 medical clinics are being warned to alert patients who received suspect steroid injections.

Five people have died from the illness, which the CDC has linked to products from a Massachusetts-based pharmacy firm.

Officials say they found contamination in a sealed steroid vial at the New England Compounding Center.

The firm recalled the steroid doses and has since shut down operations, but the vials have already been shipped to 23 states.

Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, and fever as well as slurred speech and difficulty walking.

The fungal meningitis causing concern in the US is not infectious, the CDC says.

Confirming that 47 people were now affected – an increase of 12 in the space of 24 hours, the CDC said new cases were reported for the first time in Michigan.

In Tennessee, which has the majority of the cases, a total of 29 people have now fallen ill. There were six cases in Virginia, three in Indiana Indiana, two each in Maryland and Florida and one in North Carolina, the CDC said.

It is not yet clear how many patients may have been exposed to any contamination, and fungal meningitis can have a lengthy incubation period.

A briefing by the CDC and the Food and Drug Administration (FDA) on Thursday said a fungus linked to the steroid medication had been identified in tests of five patients.

“Out of an abundance of caution, we advise all health care practitioners not to use any product” from the company, said Ilisa Bernstein, director of compliance for the FDA’s Center for Drug Evaluation and Research.

New England Compounding Center is a type of pharmacy that mixes ingredients for customized medicines. The steroid in question was three lots of methylprednisolone acetate from the firm.

On Friday, the CDC listed about 75 clinics and medical centres that received the suspected lots, and told doctors to immediately contact patients who have had an injection.

Tests are under way to confirm if the contamination is the same fungus blamed in the outbreak. The disease cannot be passed from person to person.

Three people have died in Tennessee, with one death in Virginia and one in Maryland, reports say.

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