Infections from tainted steroids ranged in severity: update

by Amy Norton, Healthday Reporter
Infections from tainted steroids ranged in severity: update
CDC study looked at meningitis, other conditions in 6 hardest-hit states.

(HealthDay)—The tainted steroid injections that caused a deadly meningitis outbreak last year seem to have triggered a broad range of symptoms in patients, according to a new study by the U.S. Centers for Disease Control and Prevention.

Since it began in September 2012, the outbreak of fungal has sickened 750 people in 20 states, resulting in 64 deaths, based on the latest CDC figures from last month.

The illnesses have all been traced to fungus-contaminated steroid medications that were given in injections to treat back and joint pain. A single company, the Massachusetts-based New England Compounding Center, distributed the drugs.

In the Oct. 24 issue of the New England Journal of Medicine, CDC researchers give a fuller account of the illnesses in six U.S. states that were hardest hit by the outbreak.

"This is the first detailed look at the early clinical course of patients involved in this outbreak," said study author Dr. John Jernigan, of the CDC's division of healthcare quality promotion.

Of 328 people who fell ill after having near the spine, 81 percent had an affecting the (CNS)—the brain or spinal cord. That usually meant meningitis, which is an inflammation of the membranes around the spinal cord and brain.

Some people had other types of infections of the central nervous system, either in combination with meningitis or not. Thirty-five people suffered a stroke—believed to be caused by the meningitis, Jernigan said—and strokes were to blame for most of the 26 deaths in these states.

The rest of the patients (19 percent) had infections that stayed localized to the injection site and did not get into the central nervous system—such as infections of the discs between the vertebrae.

Overall, the severity of patients' symptoms ranged from "very mild" to "life-threatening," the CDC team reported.

According to Jernigan, it's not clear why some people's infections did not invade the central . But nearly all of those non-CNS infections were seen in one state, Michigan. "We don't have an explanation for that," Jernigan said.

Whatever the details of the infections, the bottom line remains the same, according to Dr. Michael Carome of the Washington, D.C.-based watchdog group Public Citizen.

"This was a public health disaster," said Carome, who heads Public Citizen's health research group. "We think the great tragedy is, this was wholly preventable."

The tainted steroids behind the outbreak were made in a process called compounding, where a pharmacist mixes or alters drug ingredients to create a medication that meets particular patients' needs.

According to the U.S. Food and Drug Administration, compounding fills a vital role for people who have special medication needs. If they are allergic to a dye used in an FDA-approved drug, for instance, compounding pharmacies can remove that dye.

The problem, according to Public Citizen and other groups, is that some compounding pharmacies have moved into widespread drug distribution that goes beyond their traditional scope. Compounded drugs are not approved by the FDA, Carome pointed out, and the pharmacies themselves have escaped the FDA scrutiny that drug manufacturers face.

But that's not because the federal agency lacks the authority, Carome said. Oversight of the specialty pharmacies has traditionally fallen to states, but when the companies take on large-scale manufacturing, the FDA should, and needs to, step in, according to Public Citizen and other critics.

"We believe they already have the authority to intervene," Carome said. "Moving forward, we think the FDA needs to be more aggressive in its enforcement."

Since the outbreak, the agency has stepped up its inspections of compounding pharmacies, and there have been a number of injection-product recalls from various pharmacies due to concerns about contamination.

For its part, the New England Compounding Center ceased operations after the start of the fungal last fall.

The CDC and state officials estimate that around 14,000 Americans may have gotten steroid injections from the . One particular steroid, methylprednisolone acetate, has been linked to the disease outbreak.

As for what the public can do, Carome advised asking questions. If your doctor recommends an injection medication, he said, ask whether it's a compounded product. "If it is," Carome said, "ask why you're getting it, and whether there's an FDA-approved alternative."

At this point, study author Jernigan said, it's "very unlikely" that anyone exposed to steroids from the New England Compounding Center will fall ill. "But we can't say there's no risk," he added.

Jernigan agreed that the highlights the dire consequences of medication contamination. "Very bad things can happen when people are exposed to contaminated drugs," he said. "We need to take steps to make sure the medication supply is safe."

More information: The U.S. Food and Drug Administration has more about the risks of pharmacy compounding.

add to favorites email to friend print save as pdf

Related Stories

FDA chief renews push for specialty pharmacy rules

Dec 19, 2012

(AP)—The head of the Food and Drug Administration renewed her push for new rules to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest ...

Consumer watchdog asks FDA to revisit compounders

Nov 29, 2012

(AP)—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded ...

Recommended for you

Ebola reveals shortcomings of African solidarity

19 hours ago

As Africa's leaders meet in Ethiopia to discuss the Ebola crisis, expectations of firm action will be tempered by criticism over the continent's poor record in the early stages of the epidemic.

Second bird flu case confirmed in Canada

Jan 30, 2015

The husband of a Canadian who was diagnosed earlier this week with bird flu after returning from a trip to China has also tested positive for the virus, health officials said Friday.

What exactly is coronavirus?

Jan 30, 2015

The conflicts in Syria and Iraq are straining public health systems and public health efforts meant to prevent and detect the spread of infectious diseases. This is generating a "perfect storm" of conditions for outbreaks. Among the infections raising concern is Middle East Respiratory Syndrome, caused by a type of coronavirus, which emerged in 2012. ...

Scientists find Ebola virus is mutating

Jan 30, 2015

(Medical Xpress)—Researchers working at Institut Pasteur in France have found that the Ebola virus is mutating "a lot" causing concern in the African countries where the virus has killed over eight thous ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.