Posts Tagged 'outbreak'

Meningitis pharmacy was violating law

According to a USA Today story about an ongoing fungal meningitis outbreak, the specialty pharmacy responsible has been flagrantly violating both sanitation standards and the terms of the federal laws permitting it to operate.

But the story characterizes the problem not simply as the practices of a single irresponsible business, but a systemic failing that’s permitted “compounding pharmacies” to operate on a large scale under relatively lax regulatory standards.

And patients who ...

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Hepatitis outbreak linked to frozen berries

An outbreak of hepatitis A has been reported in five western states, and government officials say frozen berries may be the source.

A CBS News report says the illnesses were first reported in April, and 30 people have since been infected in Colorado, New Mexico, Nevada, Arizona and California. Nine of them have been hospitalized.

Officials with the U.S. Centers for Disease Control and the U.S. Food and Drug Administration have linked the ...

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Senate compounding pharmacy bill criticized as too soft

A U.S. Senate committee has approved a bill designed to impose tighter restrictions on compounding pharmacies, such as the one blamed for a deadly meningitis outbreak. The legislation is now headed for the full Senate.

But according to a story in the Washington Post, consumer health and public advocacy groups are criticizing the proposed legislation for not going far enough.

Compounding pharmacies are specialty pharmacies that prepare medications from ingredients provided by ...

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Fungal meningitis presents danger of relapse

A deadly fungal meningitis outbreak apparently caused by tainted medication may present yet another hazard for patients, according to a NBC News story.

Officials with the U.S. Centers for Disease Control and Prevention report a relapse in an 80-year-old man who developed meningitis last year.

The CDC officials wrote of that case in a recent edition of the New England Journal of Medicine.

According to the CDC, the outbreak has read more.... --> continue reading...

Inspection prompts medicine recalls

Following an inspection by the U.S. Food and Drug Administration, a Florida specialty pharmacy called The Compounding Shop is recalling all of its sterile products, ABC News reports.

According to the story, FDA inspectors were concerned about sterility problems with company drugs that could lead to bacterial contamination. The agency advised health care professionals to keep drugs produced at the company away from patients.

The FDA investigation was part of a wave ...

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FDA chief says more authority needed on compounders

Food and Drug Administration Commissioner Dr. Margaret A. Hamburg has admitted that her agency wasn’t aggressive enough in investigating compounding pharmacies, such as the one responsible for a deadly, nationwide meningitis outbreak.

But in a hearing before a House Energy and Commerce subcommittee, Hamburg also said the agency needs stronger legal authority if it’s going to make such pharmacies conform to stricter safety standards, the New York ...

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