Tag Archives: Outbreak
Oct. 15, 2012 — More patients — not just those who got steroid shots — will be getting calls from their doctors warning them they might have a dangerous fungal infection.
The FDA now suspects fungal contamination is possible in all of the supposedly sterile products made by the New England Compounding Pharmacy (NECC) on or after May 21, 2012. People who got shots of any of these medicines — particularly those given during eye treatments or heart surgery — are at risk.
There’s already one possible case of fungal meningitis in a patient who received a different NECC steroid product (triamcinolone acetonide) than the three lots of methylprednisolone known to have infected patients.
Two people who received an NECC heart medication during transplant surgeries have fungal infections. The heart drug is called cardioplegic solution and is used to temporarily stop the heart during open heart surgery.
It’s not clear whether those infections came from the NECC drug or something else. So far, there have been no reported cases of eye infections linked to NECC products.
“At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC, are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the FDA today warned in a statement.
The CDC now has two reports of fungal infections in patients who received NECC steroid shots in the knee, hip, shoulder, or elbow.
Including these cases, 214 people in 15 states got fungal infections traced to NECC products. Fifteen patients have died.
Today’s warning applies only to sterile drugs delivered by injections. “At this time,” the FDA notes, the warning does not include NECC products applied as lotions, creams, eye drops, or suppositories. Before shutting down operations, the NECC offered more than 2,100 different products for sale in all 50 states.
The FDA advises doctors that they may get a lot of calls from patients and to use their judgment about who is at risk.
Symptoms of Fungal Infection, Fungal Meningitis
People who received injections of NECC drugs should be alert for symptoms of fungal infection:
- Increasing pain, redness, or warmth at injection site
- Changes in vision (if injection was in the eye)
- Pain, redness, or discharge from the eye (if injection was in the eye)
- Chest pain (if drug was used during heart surgery)
- Drainage from the surgical site (infection within the chest, if drug was used during heart surgery)
Symptoms of fungal meningitis may be very mild at first. They may include slight weakness, slightly worse pain, or a mild headache. Other symptoms include fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status.
The CDC warns patients who received suspect medications to be alert for:
- New or worsening headache
- Sensitivity to light
- Stiff neck
- New weakness or numbness in any part of your body
- Slurred speech
- Increased pain, redness, or swelling at your injection site
While most patients with infections developed symptoms one to four weeks after infection, the CDC remains unsure how long those who received suspect medications should be on the alert.
The FDA has extended its investigation to include Ameridose, another Massachusetts compounding pharmacy owned by some of the same people who own the NECC. So far, no Ameridose products have been linked to fungal meningitis.
THURSDAY Oct. 11, 2012 — Most Americans had probably never heard the term “compounding pharmacy” until the meningitis outbreak tied to contaminated steroid injections produced at a Massachusetts facility erupted last month.
Compounding is a time-honored practice in which pharmacists “combine, mix, or alter ingredients to create unique medications to meet specific needs of individual patients,” according to the U.S. Food and Drug Administration.
The customized drugs are frequently required to accommodate special needs, such as a smaller dose, or the removal of an ingredient a patient is allergic to. Sometimes compounding pharmacies also produce drugs when FDA-approved manufacturers are unable to meet demand, as during drug shortages.
But over time, the practices of some compounding pharmacies — traditionally community-based neighborhood druggists — have expanded, often beyond their intended limits, experts explained.
In the last decade, firms with “pharmacy licenses making and distributing unapproved new drugs in a way that’s clearly outside the bounds of traditional pharmacy” has become a worrisome trend, according to the FDA website.
“Consumers need to be aware that compounded drugs are not FDA-approved,” said Kathleen Anderson, deputy director of the FDA’s Division of New Drugs and Labeling Compliance in the Center for Drug Evaluation and Research. “This means that FDA has not verified their safety and effectiveness.”
Steve Silverman, assistant director of the FDA’s Center for Drug Evaluation and Research, added: “The methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies. Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship.”
On Wednesday, the governor of Massachusetts, Deval Patrick, said the compounding pharmacy at the center of the meningitis outbreak — New England Compounding Center of Framingham — may have deceived state officials and done work not authorized by its state license. The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said, the Associated Press reported.
“What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license,” Patrick said.
A spokesman for the compounding center declined to respond to the governor’s remarks, the AP said. The company has shut down operations and recalled its products.
Gary Dykstra, a professor at the University of Georgia College of Pharmacy who worked for the FDA for 40 years, said that while “pharmaceutical compounding started out with clear intentions, it has grown to be a very commercialized enterprise.”
Why would physicians order routine medications from a compounding pharmacy rather than an FDA-approved manufacturer?
“It’s a dollar-and-cents world out there and this particular compounding center was very adept at marketing their product at a good price,” said Dykstra.
Dr. Neil Roth, an orthopedic surgeon at Lenox Hill Hospital in New York City, agreed that money is a big motivator. “It’s cheaper,” he said. “Buying from a compounding pharmacy gives a greater profit margin. People are doing this for cost effectiveness.”
To date, 12 people have died and 137 have been sickened in the meningitis outbreak apparently linked to contaminated steroid injections produced by the New England Compounding Center.
Health authorities believe that all of the patients were injected with methylprednisolone acetate, a steroid drug routinely used to treat stubborn back pain. Investigators suspect the product was tainted with a fungus that’s common in the environment and is often found in leaf mold, according to the U.S. Centers for Disease Control and Prevention.
As many as 13,000 people in 23 states may have gotten the shots, federal health officials said. The 13,000 figure includes not only people who got injections for back pain and are most at risk for meningitis, but also others who received injections for pain in their knees and shoulders. While nonsterile injections into the spine can make people susceptible to meningitis, the shots are likely to cause localized infections when injected into joints.
The steroid methylprednisolone acetate is available from large vendors that manufacture it on a large scale, Roth explained. “It’s a widely available soluble type of cortisone that doesn’t erode cartilage or tendons and gives a quick dosing effect,” he explained.
While the reported meningitis cases have been related to patients getting spinal injections, Roth noted that injections of the drug — if tainted — into other joints, such as the knee, hip or shoulder, could cause troubling infections.
How could a rare fungal infection taint a drug while it is being manufactured?
The production of methylprednisolone acetate requires sterile conditions, said Dykstra. “Mold is everywhere. If the drug is not produced properly, adhering to the necessary manufacturing processes, anything is possible,” he said.
According to the International Academy of Compounding Pharmacists (IACP), an industry group, about half of the 56,000 community-based pharmacies create “custom drugs” by compounding. It estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services, with 3,000 providing sterile compounding.
The IACP said that compounding pharmacies have been typically used to create drugs when FDA-approved drug makers are unable to fulfill demand. The organization estimates that as much as 3 percent of the approximately $ 300 billion in prescription drugs sold in the U.S. annually are produced by compounding pharmacies.
While the FDA oversees the manufacture of pharmaceutical products, states oversee compounding pharmacies, typically through pharmacy boards.
The FDA has tried in the past to increase its role in overseeing compounding pharmacies. But it was stopped, Dykstra said, by a 2002 U.S. Supreme Court decision that struck down a portion of a 1997 law that had given the FDA the ability to develop regulations for the compounding industry.
“The FDA was up against a wall and couldn’t do much after that,” said Dykstra.
Dykstra said Congress now needs to act. “They need to deal with the fact that the fix they put in place in 1997 did not do the job and it paralyzed the FDA.”
Some in Congress are already responding to the crisis.
“This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws,” Rep. Henry Waxman, (D-Calif.) and two other Democrats on the House Energy and Commerce Committee — Diana DeGette of Colorado and Frank Pallone Jr. of New Jersey — said in a statement.
However, Dykstra cautioned that implementing constraints on compounding pharmacies may create shortages and raise costs, at least in the short term, especially if some are shut down or avoided because of the issues raised by the meningitis outbreak.
Dykstra said people who are considering getting a spinal injection for pain relief should ask their physician specifically where the drug came from, and “maybe even see it for themselves to be sure it’s from a known drug company.”
Roth agreed. “A physician may not know where the drug they use is coming from,” he said. “I buy methylprednisolone acetate from a big distributor. We put our trust in the manufacturer of the drug.”
Roth believes there’s a role for compounding pharmacies but creating this type of drug isn’t it. “If it were me, I wouldn’t want some pharmacy creating methylprednisolone with a mortar and a pestle going into my spine or knee. I’d want the most sterile thing available.”
To learn more about compounding pharmacies, visit the U.S. Food and Drug Administration.
Posted: October 2012
Recalled Frescolina Ricotta Salata Linked to 14 Illnesses in 11 States, D.C.
Sept. 12, 2012 — Three people have died and 11 others are hospitalized after eating recalled Frescolina brand ricotta salata cheese contaminated with listeria bacteria.
The Sept. 10 recall by Forever Cheese Inc. included one lot of the imported Italian cheese. It was sold to restaurants and retailers in California, Colorado, Washington, D.C., Florida, Georgia, Illinois, Indiana, Maine, Maryland, Massachusetts, Montana, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Virginia, and Washington between June 20 and Aug. 9.
The recall affects lot number T9425 and/or production code 441202. Products were sold to supermarkets, restaurants, and wholesale distributors. Ricotta salata is a crumbly, solid cheese. It is not the same as ricotta cheese, normally sold in plastic containers or tubs.
As of Sept. 11, the CDC had reports of 14 illnesses, in California (1 case), Colorado (1), Washington, D.C. (1), Maryland (3), Minnesota (1), Nebraska (1), New Jersey (1), New Mexico (1), New York (1), Ohio (1), Pennsylvania (1), and Virginia (1).
The three deaths occurred in Minnesota, Nebraska, and New York.
Four of the illnesses were linked to pregnancies. There were no fetal deaths, but two of the cases were in newborns.
The CDC advises people not to eat imported Frescolina brand ricotta salata cheese, particularly if they are pregnant, have a weakened immune system, or are older adults.
The cheese has a four-month shelf life, so it still may be in refrigerators or for sale at stores.
If the cheese is found in your home:
- Throw it away in a sealed plastic bag into a sealed trash can.
- Use hot water and soap to wash areas of the refrigerator where the cheese was stored.
- Wash all cutting boards, utensils, and surfaces that came into contact with the cheese. If possible, use the dishwasher to clean these items.
- While pregnant women usually get a mild flu-like illness, listeria infection can cause miscarriage, stillbirth, premature delivery, or fatal infection of the newborn.
- Other adults may develop headache, stiff neck, mental confusion, loss of balance, and convulsions.
- Young children, older adults, and people with weakened immune systems are at greater risk of serious infection.
Cooking kills listeria bacteria, but they can grow and multiply in the refrigerator.
3 Deaths, 8 Cases as Warnings to Park’s Summer Visitors Expand
Sept. 7, 2012 — A third person has died of hantavirus infection in this summer’s outbreak at Yosemite National Park.
Two other park visitors now have become ill, bringing the total case count to eight.
Seven of the eight were infected after staying in the Boystown tents that are part of the Curry Village area of the park. But one of the new cases had no contact with Curry Village. That person stayed miles away in four of Yosemite’s remote High Sierra tents used by hikers and horseback riders.
The hantavirus strain common to the Yosemite area is sin nombre virus. It’s carried by deer mice. The animals’ droppings, urine, and saliva contaminate dusty areas with virus. When the dust is disturbed, people breathe in the virus and become infected.
The National Park Service and park contractor DNC Parks & Resorts already sent emails and letters to people who stayed in the popular Curry Village tents from mid-June through August. They now are sending new emails and letters to those who stayed in the High Sierra tents and other areas. In all, about 22,000 park visitors have received the warnings.
The letters warn visitors to get immediate medical help if they have any flu-like symptoms. It could be a sign they’re on the way to hantavirus pulmonary syndrome. Early treatment is the best way to avoid this serious, life-threatening illness.
Hantavirus illness begins one to six weeks after exposure to the virus. Early symptoms include feeling tired, fever, chills, and muscle aches. Half of patients also get headaches, nausea, vomiting, dizziness, and abdominal pain. Over the next four to 10 days, they begin to cough and feel short of breath. They soon have great difficulty breathing.
Different kinds of mice and rats carry different hantavirus strains in different parts of the U.S. Nationwide, about 20% of these rodents are thought to carry hantavirus.
When cleaning up after a rodent infestation, first be sure to eliminate living rodents and seal the area against new infestations. Disturbed areas and dead animals should be sprayed with disinfectant (one part bleach to nine parts water), left to sit for five minutes, and wiped up wet while wearing rubber or plastic gloves. Be sure to disinfect the gloves and wash your hands when you’re done. Never sweep or vacuum up rodent droppings or rodent nests — this can throw hantavirus-carrying dust into the air.