FDA: Check all patients who got drugs from pharmacy suspected in meningitis outbreak

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The New England Compounding Center is shown here on October 5, 2012 in Framingham, Mass. The pharmacy is currently being investigated for producing a contaminated steroid injection, and possibly other contaminated drugs.

Federal health officials have expanded their investigation of an outbreak of fungal meningitis, asking doctors to follow up with all patients treated with any products from a Massachusetts pharmacy. They said 233 people have been diagnosed with infections, and 15 of them have died, and federal agents raided the center on Tuesday.

Food and Drug Administration officials said an inspection of the New England Compounding Center raises concerns about its cleanliness procedures, and doctors need to reach out and make sure patients are all right. They want doctors to check not only people who got injections of steroids into their spines to treat pain, but patients treated with any product, from nipple cream to painkillers and steroids.

“We have looked at practices of the firm and we are concerned that we cannot provide assurances of sterility,” said the FDA’s Dr. Janet Woodcock. Woodcock said confidentiality concerns prevented her from giving details about what those practices might be.

“We are asking that clinicians who administered these products since the end of May actively contact their patients in some way,” Woodcock told doctors on a conference call. “We cannot assure right now that these products that were administered were sterile.” She says doctor's offices and clinics should call or write patients to ask about any symptoms they may have.

At first the outbreak only involved people treated with a steroid called methylprednisolone and only three specific lots of that drug made by NECC.

On Monday the FDA raised concerns about two more drugs -- a steroid called triamcinolone acetonide and another a product called cardioplegia used during heart surgery. At least three patients treated with those products have infections, although it's not certain they have fungal infections.

Woodcock said the FDA wasn’t sure how many patients might need follow-up from their doctors. Nearly 14,000 people got injections from three suspect lots of methylprednisolone, but the company shipped dozens of different drugs, many of them injectibles.

"We would like clinicians to report to us. We would like them to follow up with the patients and if there are any infections, we would like to hear about it," Woodcock said. "We know that NECC shipped large volumes of various products. We do not know how many."

A third mold called Cladosporium has now been found in a patient as well, said Dr. Tom Chiller of the Centers for Disease Control and Prevention. It is similar to Exserohilum, the mold most commonly found in patients with meningitis affected in the outbreak. CDC experts said it was possible other contaminants may be found, as well.

But the CDC still advises that only patients with clear signs of inflammation be treated with antifungal drugs. Patients who do need treatment likely face a minimum of three months of therapy, experts said.

Dr. Peter Pappas of the University of Alabama at Birmingham said doctors have never had to deal with anything like the current outbreak, and he said they are learning as they go along.  "It’s not clear to me at all what is going to occur," he said on the conference call. Fungal infections can grow very slowly, and it could take a long time for infected patients to have any symptoms.

Two patients who were injected with steroid from NECC in the ankle have some kind of infection, CDC officials said. They are being counted among the 233 total victims because the infections are bacterial or viral in origin, so are presumed to be fungal. They're not in immediate danger in the same way meningitis patients are, but could also have to undergo months of antifungal therapy.

Some of NECC's products are creams or eye drops and the experts were reassuring about patients who may have used those, even if they turn out to have been contaminated. All three molds that have been identified are fairly common in the outdoors. "These are things we are exposed to every day in nature," he said. Most healthy patients who get them on the skin, in the eye or even who inhale them are not likely to become infected, he said. The biggest risk is to patients who had contaminated drugs injected into the spinal fluid.

The FDA and state regulators are checking to see how and why NECC shipped so many drugs to so many different places when it was supposed to be a compounding pharmacy -- one that makes drugs to order for individual patients. FDA had warned NECC several times both about sterility procedures and about doing business beyond its licensed permission.

Members of Congress say they are investigating the matter, as well. The House Energy and Commerce Committee has asked FDA, CDC and NECC officials to appear before a hearing by the end of the week. Members have also asked the Justice Department to investigate whether the NECC broke Drug Enforcement Administration regulations by selling morphine and other controlled substances.

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Remember. Only WITH DEREGULATION, can American business succeed! Keep on going! Tell the FDA and other nosy regulators where to stick their nosy noses! No regulations are BEST for American companies! And of course, what's good for business is good for citizens! (This of course, is ALL heavy sarcasm. But wait and listen. In 2 or 3 years after all this fall-out ends and new regulations are created, some politician looking for money will propose undoing all these "harmful, unnecessary regulations strangling" American business. I remember the 1970s, 1980s and 1990s.)

  • 4 votes
Reply#1 - Tue Oct 16, 2012 4:25 PM EDT

This is all so sad. If this is because of the lack of drug regulation (if there is any), shame on you for being lazy...

Many people are on the brink of death now, and a handful already have died.

  • 2 votes
Reply#2 - Tue Oct 16, 2012 5:15 PM EDT

They were operating totally outside the scope of their license. 15 counts of manslaughter and counting. Zombie capitalists, they kill for money.

  • 1 vote
Reply#3 - Tue Oct 16, 2012 6:29 PM EDT

Bet this has happened befor and the hospital blamed the doctor or nurse for unsanitary conditions.

    Reply#4 - Tue Oct 16, 2012 6:37 PM EDT

    I am in south carolina. only one dr firm got the bad meds. Does the mass compounding pharmacy sell at a lower price?

      Reply#5 - Tue Oct 16, 2012 6:40 PM EDT

      Does this compounding pharmacy sell meds cheaper than most "regular" supply chains?

        Reply#6 - Tue Oct 16, 2012 6:43 PM EDT

        Will the upcoming election affect FDA funding? There’s a lot of money and public health issues riding on the answer. The good news is the FDA recently secured more revenue through the approved user fee act. The bad news is Willard Mitt Romney has stated he will Repeal the Affordable Care Act which contains the benefits of the approved user fee act.

        Currently there is not enough money in the Budget to hire enough inspectors. The Affordable Care Act tried to rectify this by implementing the approved user fee act. Romney-Ryan want to dismantle the entire program leaving even more of the population vulnerable to such instances as this one.

          Reply#7 - Tue Oct 16, 2012 6:44 PM EDT

          I really don't know how these comments are going to help save lives. This bad practice is killing people when are they going to be held accountable. If any one of us poisoned some one we would surly go to prison.

          And the government keeps blowing it off. People eating contaminated food because all they care about is profits.

          And it seems to me no one is prosecuted just a slap on the hand, does the Gov care about children that have been sickened or die from bad food or all the drugs they put out that the side affects are worse than the the the medical problem one has?

          We must demand more for are safety is it not why the food and drug Admin. Was established?

          It seems to me they have no teeth these people who do harm should be prosecuted.

          What do all of you think do we not deserve this for us and are family's.

            Reply#8 - Tue Oct 16, 2012 6:45 PM EDT

            doctors are telling the people if they got the drug from/ that lab i know this many doctors are saying nothing and hopeing for the best it just dum

              Reply#9 - Wed Oct 17, 2012 10:04 AM EDT

                Reply#10 - Wed Oct 17, 2012 7:33 PM EDT

                Darkfield Microscopy will identify the fungus and what stage in it's life cycle it is.

                  Reply#11 - Wed Oct 17, 2012 7:35 PM EDT

                  These victims are like I was........scared.....because the US banned the Darkfield.......guess why?

                  • 1 vote
                  Reply#12 - Wed Oct 17, 2012 7:38 PM EDT

                  Why? And what is "the Darkfield"??

                    #12.1 - Thu Oct 18, 2012 1:12 PM EDT

                    Hello Laurie.........the Darkfield saved my life. After dental surgery I became very ill. Went all over this country including the Mayo Clinic for two weeks. ......and got nothing answered except that it was all in my head. So, I went to a clinic outside of the US where they did a live blood test (Darkfield )....... Which showed aspergillus in my blood and at what stage the fungus was in of it's life cycle. It was in a late stage so my prognosis was not good. After many therapies( not the toxic anti-fungals they use here )... I started to improve. So this is a simple, quick, inexpensive test that should be used in the US. Especially for fungal infections as you keep reading how hard they are to diagnose. Have reached out to some of the victims....don't know if I am helping by telling them there is a better test for them......but, oh by the way, they can't get it here. Such a sad medical world we have.

                      #12.2 - Fri Oct 19, 2012 3:44 PM EDT
                      Reply

                      I want to hear more about the nipple cream.

                      • 1 vote
                      Reply#13 - Wed Oct 17, 2012 8:28 PM EDT

                      I used to have a Gynecologist that would view specimens under a microscope herself, not trust outside labs with questionable or over-worked technicians. At times modern, up-to-the-minute is not always better. I like the idea of hospitals doing compounding on their own, sterile premises when possible.

                      At least one hospital system, Maryland-based Medstar, says it has begun compounding its own products when possible now to ensure their sterility. Bonnie Levin, who heads pharmacy services at Medstar, told NBC News the hospitals have rooms that are as sterile as operating rooms to do this. - http://vitals.nbcnews.com/_news/2012/10/17/14513607-four-more-die-in-fungal-meningitis-outbreak#comments

                        Reply#14 - Wed Oct 17, 2012 9:21 PM EDT

                        Not sure if your reference is towards the Darkfield or not. However I spent 3 years going to major medical facilities including the Mayo Clinic and got not one answer except it was all in my head. It definitely was in my head.......my jaw was infected with aspergillus and they never found anything after three weeks! I finally found answers outside of the US. These people can be diagnosed quickly if we help them!

                          Reply#15 - Wed Oct 17, 2012 9:44 PM EDT

                          I use Triamcinolone Acetonide Cream USP, 0.1%. Is the cream safe to use? I can't find any info re: this.

                            Reply#16 - Sun Oct 21, 2012 3:51 AM EDT
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