Announcement

Collapse
No announcement yet.

US - CDC reports 63 dead, 749 infected with fungal meningitis in 20 states (Update Aug 5, 2013)

Collapse
This is a sticky topic.
X
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • Re: US - 19 dead, 247 sick from suspected fungal meningitis as outbreak worsens

    CDC update for Oct. 20th ((NOTE: As of 5 pm there are no updates to case definitions, clinician or patient guidance.):



    • Status: Ongoing Investigation
    • Infection: Fungal
    • Facility Type: Outpatient Setting
    • Case Count: 284
    • States: 16
    • Deaths: 23



    "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

    "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

    Comment


    • Re: US - 23 dead, 284 sick from suspected fungal meningitis as outbreak worsens

      The case number is only up by 1 today - with a new case being reported in Indiana.

      CDC Update for Oct. 21st (NOTE: As of 3 pm there are no updates to case definitions, clinician or patient guidance.):

      • Status: Ongoing Investigation
      • Infection: Fungal
      • Facility Type: Outpatient Setting
      • Case Count: 285
      • States: 16
      • Deaths: 23



      "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

      "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

      Comment


      • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

        Meningitis outbreak: Tracing steroid path in body proves difficult

        Spinal dura may have been pierced in some fatal cases

        <?xml:namespace prefix = fb ns = "http://www.facebook.com/2008/fbml" /><fb:like class="fb_edge_widget_with_comment fb_iframe_widget" width="429" action="recommend" show_faces="false" href="" fb-xfbml-state="rendered" send="false" font="" ref="artrectop"></fb:like>3:37 AM, Oct 22, 2012

        ...
        Dr. Michael Baden, a high-profile forensic physician in New York, said it was possible that in at least some of the fatal cases the person administering the epidural steroid may inadvertently have pierced the spinal dura, the protective coating around the spinal canal.

        If that occurred, the fatal fungus would have a direct path to the victim?s brain, he said.

        That also could explain why some victims died much more quickly than others, Baden said. Health officials with the U.S. Centers for Disease Control and Prevention have said that while some patients became ill with fungal meningitis within a week, others did not show symptoms for six weeks.

        But Baden and others say that determining whether that protective coating was breached could be difficult.

        ?Any perforation of the dura will heal after a few days,? he said. ?The chances of finding that puncture are remote.?

        He said it also was possible that the fungus could penetrate the dura even if there were no puncture.
        ...
        Dr. Cyril Wecht, a Pittsburgh pathologist, said piercing the dura ?is something that should not happen.?

        But he added that he would not be surprised if it did happen in some of the meningitis cases being studied by state and federal health experts.
        ...

        Full text:
        "Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear."
        -Nelson Mandela

        Comment


        • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

          ?Worried Sick?: Meningitis Risk Haunts 14,000</NYT_HEADLINE>

          By DENISE GRADY
          Published: October 21, 2012
          ...

          As early as Monday, health officials may be able to offer doctors a method to estimate a patient?s risk and help decide how aggressive the follow-up should be, Dr. Marion Kainer of the Tennessee Health Department said on Friday during a telephone conference.

          In Tennessee, which has had more cases and deaths (69 cases and 9 deaths as of Saturday) than any other state, the State Health Department has found that one lot (06292012@26) infected more patients than others, and that the older the medicine when it was given and the higher the dose, the more likely a patient was to get sick. But Dr. Kainer emphasized that another lot (08102012@51), more of which went to other states, also appeared to be heavily contaminated and risky. She said researchers thought older medicine was riskier because the fungus was multiplying in the vials and making them more dangerous.

          The earlier treatment begins, the better. Doctors do not want to wait until patients become seriously ill ? but they say they must also avoid treating people who are not infected, because the drugs have severe side effects.
          Yet doctors responding to the outbreak say it can be extremely difficult to determine whether symptoms are getting worse in people who were probably already suffering from chronic pain.

          The stress of knowing that they have been exposed to a potentially deadly infection is also making matters more difficult. During the teleconference, one doctor said, ?To be real honest, I believe I would have symptoms if I had been told I was given this medication.?
          ...

          Full text:
          "Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear."
          -Nelson Mandela

          Comment


          • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

            I still can't find out any clear information about whether or not this stuff was exported. It's seem plausible, given that drugs seem to come from all over the world, that some lots were sent to out countries like Canada and Mexico. But a call to CDC sent me to Tennessee - both useless - and then to FDA which won't even take calls from outside the US. Of course, Health Canada has not responded yet to emails.

            Anyone know more about how the world of drug shipments work?

            J.

            Comment


            • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

              Interesting question.

              No products from NECC should be used. The company has recalled all products.

              I called the FDA and The Office of Drug Information has a recording that says their office is closed.

              To be on the safe side any public health authority could issue a nationwide advisory citing USA FDA info and the above recall notice.

              Comment


              • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                Originally posted by sharon sanders View Post
                Interesting question.

                No products from NECC should be used. The company has recalled all products.
                Canada assigns a unique identifier to each drug: "drug identification number" or DIN.

                With that unique key, insurers of any type can search "backwards": look at each payment transaction for that DIN to identify the cohort of purchasors, and perhaps the patient, Dr., and pharmacy

                Drs. can find out what drugs a patient has taken, but that's a "forward" analysis: going from the individual to gain the set of drugs taken by that person.

                The FDA list doesn't have any such number, just the generic name of the drug. Aside from the fact that numerous manufacturers make the same product, matching databases is next to impossible without the unique key.

                So another angle is to ask if any of the NECC products were in the country in the first place.

                J.

                Comment


                • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                  I will start sending out emails. I am not sure who has that information now. The FDA raided NECC. Groan. What a mess.....

                  Comment


                  • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                    This just came out.

                    Update on Fungal Meningitis

                    FDA provides NECC Customer List

                    [10-22-2012] On October 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed from its Framingham, Massachusetts facility. A complete list of all NECC products subject to this recall can be accessed here [HTML | PDF]. On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.

                    Today, FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.
                    FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
                    • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
                    • The medication was shipped by NECC on or after May 21, 2012, and
                    • The medication was administered to patients on or after May 21, 2012.

                    Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination. Now that we have shipping information available, we are updating FDA’s recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.

                    Advice to NECC Customers

                    Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

                    Advice to Patients

                    Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.
                    Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with their healthcare providers unless they are experiencing symptoms of infection.

                    Advice to Healthcare Professionals

                    FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012. Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.
                    Health care professionals should retain and secure all remaining products purchased from NECC. All NECC products are subject to voluntary recall. Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
                    Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.
                    Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.
                    If you have identified NECC customers who received product that do not appear on these lists, please contact FDA’s Drug Information Line to report this problem.
                    FDA continues its investigation and may issue additional public communications as appropriate.

                    -

                    Related Information




                    -




                    Contact FDA

                    1-800-332-1088
                    1-800-FDA-0178 Fax
                    Report a Serious Problem MedWatch Online
                    Regular Mail: Use postage-paid FDA Form 3500
                    Mail to: MedWatch 5600 Fishers Lane
                    Rockville, MD 20857



                    Update on Fungal Meningitis

                    FDA provides NECC Customer List

                    [10-22-2012] On October 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed from its Framingham, Massachusetts facility. A complete list of all NECC products subject to this recall can be accessed here [HTML | PDF]. On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
                    Today, FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.
                    FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
                    • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
                    • The medication was shipped by NECC on or after May 21, 2012, and
                    • The medication was administered to patients on or after May 21, 2012.

                    Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination. Now that we have shipping information available, we are updating FDA’s recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.
                    Advice to NECC Customers

                    Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
                    Advice to Patients

                    Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.
                    Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with their healthcare providers unless they are experiencing symptoms of infection.
                    Advice to Healthcare Professionals

                    FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012. Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.
                    Health care professionals should retain and secure all remaining products purchased from NECC. All NECC products are subject to voluntary recall. Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
                    Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.
                    Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.
                    If you have identified NECC customers who received product that do not appear on these lists, please contact FDA’s Drug Information Line to report this problem.
                    FDA continues its investigation and may issue additional public communications as appropriate.

                    -

                    Related Information




                    -




                    Contact FDA

                    1-800-332-1088
                    1-800-FDA-0178 Fax
                    Report a Serious Problem MedWatch Online
                    Regular Mail: Use postage-paid FDA Form 3500
                    Mail to: MedWatch 5600 Fishers Lane
                    Rockville, MD 20857

                    Comment


                    • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                      Number of U.S. meningitis cases from tainted injections nears 300
                      3:41 p.m. EDT, October 22, 2012


                      (Reuters) - The number of U.S. cases of meningitis from tainted injections of a steroid medication reached 294, up 12 from a day earlier, the Centers for Disease Control and Prevention (CDC) said on Monday.

                      There were three other cases of joint infections from the steroid medication that have not resulted in meningitis cases, bringing the national total of infections to 297, according to the CDC.

                      There were no new deaths reported, leaving the total number of fatalities at 23, the CDC said. The number of cases has continued to mount despite recall of the product by New England Compounding Center. Meningitis cases have been identified in 16 states and deaths in seven states.http://www.courant.com/health/sns-rt...3406602.story?
                      CSI:WORLD http://swineflumagazine.blogspot.com/

                      treyfish2004@yahoo.com

                      Comment


                      • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                        Originally posted by cartski View Post
                        Canada assigns a unique identifier to each drug: "drug identification number" or DIN.

                        With that unique key, insurers of any type can search "backwards": look at each payment transaction for that DIN to identify the cohort of purchasors, and perhaps the patient, Dr., and pharmacy

                        Drs. can find out what drugs a patient has taken, but that's a "forward" analysis: going from the individual to gain the set of drugs taken by that person.

                        The FDA list doesn't have any such number, just the generic name of the drug. Aside from the fact that numerous manufacturers make the same product, matching databases is next to impossible without the unique key.

                        So another angle is to ask if any of the NECC products were in the country in the first place.

                        J.

                        I do not see Health Canada listed as a customer but the FDA says this is the list given to them by NECC so.......

                        Comment


                        • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                          I've also tried to do some digging on this question and I'm not finding anything about exports. But it's pretty complicated as there are actually at least 3 other companies that are interconnected with NECC. They are Ameridose LLC, Alaunus Pharmacy, and Medical Sales Management. The last 2 companies seem to handle the management, marketing and distribution of products made by Ameridose and NECC.

                          I suspect that if there is an export license, it would be under the name of either Alaunus or Medical Sales Management. The website for Alaunus (here) does not mention anything about international business:

                          "Company Profile

                          Based in Framingham, Massachusetts, privately held Alaunus Pharmaceutical is an emerging pharmaceutical company that identifies, develops, and markets generic pharmaceutical products to physicians and pharmacies throughout the United States."
                          A good article that gives a pretty thorough background on the companies and their owners can be found at Pharmaceutical Intelligence.



                          "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

                          "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

                          Comment


                          • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                            The CDC update for Oct. 22nd (NOTE: As of 4:30 pm, there are no updates to the Current Situation, case definitions, or patient and clinician guidance.):

                            • Status: Ongoing Investigation
                            • Infection: Fungal
                            • Facility Type: Outpatient Setting
                            • Case Count: 297
                            • States: 16
                            • Deaths: 23



                            "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

                            "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

                            Comment


                            • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                              UPDATE 1-Meningitis probe could hit hospital drug supplies - FDA

                              Mon Oct 22, 2012 3:54pm EDT
                              By Bill Berkrot

                              Oct 22 (Reuters) - The extended shutdown of a sister company of the pharmacy at the center of the deadly U.S. meningitis outbreak may exacerbate drug shortages for some hospitals and healthcare providers as the number of infection cases neared 300, U.S. health regulators said.

                              Ameridose, a drug manufacturer owned by the same people who own New England Compounding Center (NECC), has been closed since Oct. 10 and will remain shuttered until Nov. 5, while authorities complete an inspection of the plant as a precautionary measure - at least temporarily cutting off supplies to its customers.

                              NECC shipped thousands of potentially contaminated vials of a steroid used for injections to treat severe back pain. Some 14,000 patients may have been exposed to the medicihttp://www.reuters.com/article/2012/...121022?rpc=401
                              CSI:WORLD http://swineflumagazine.blogspot.com/

                              treyfish2004@yahoo.com

                              Comment


                              • Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

                                I happened to come across this notice while looking for further information on Ameridose, etc. This notice is dated Oct. 12th and obviously only applies to Baptist Health System hospitals but this may be an issue elsewhere as well.



                                Baptist Health System:
                                ATTN: DRUG SHORTAGE - OXYTOCIN


                                Ameridose and Alaunus Pharmaceutical are temporarily ceasing distribution of all products. This impacts our supply of some narcotics and Oxytocin. This situation has created an immediate shortage of Oxytocin. We are aggressively working to obtain additional supplies from other channels through our pharmacy vendors.

                                ACTION REQUIRED: Please make every effort to conserve in a clinically-appropriate manner the use of Oxytocin. We are asking that use of L R 1000 mL with 20 units Oxytocin be used sparingly. We will keep you posted as new information is available on this situation...



                                "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

                                "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

                                Comment

                                Working...
                                X