マサチューセッツ州のNew England Compounding Center (NECC)製の心臓病薬の投与を受けたのちに髄膜炎に感染したとＦＤＡが発表した。
More drugs may be linked to meningitis outbreak: FDA
By Greg McCune and Bill Berkrot
CHICAGO/NEW YORK | Mon Oct 15, 2012 7:07pm EDT
(Reuters) - Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis.
The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. It also said two transplant patients were infected with the rare fungus linked to the meningitis outbreak after receiving a heart drug also made by the New England Compounding Center (NECC) of Framingham, Massachusetts.
Nine more people have been diagnosed with fungal meningitis linked to possibly tainted vials of the injected steroid methylprednisolone, bringing the number of cases to 212, according to the U.S. Centers for Disease Control and Prevention (CDC). A Tennessee woman among these cases filed a lawsuit on Monday against NECC seeking $15 million in damages.
The patient identified by the FDA as potentially having meningitis received an injection for pain of the steroid triamcinolone, also supplied by NECC.
The FDA said its investigation of that patient and the two who received the heart drug during surgery was ongoing, and it cautioned that any injectable drugs made by NECC, including those intended for use in eyes, are of "significant concern."
The FDA has not confirmed that these three infections were caused by NECC products.
NECC said in a statement that it was reviewing the new information from the FDA. "We continue to cooperate with the FDA, as we are with the CDC and the Board of Registration in Pharmacy of the Massachusetts Department of Public Health," it said.
The meningitis outbreak expanded to 15 states on Monday as Pennsylvania reported its first case.
The Pennsylvania patient, who received the epidural steroid injection in July, was being treated in a hospital, the Pennsylvania Department of Health said.
The nine new cases include the one in Pennsylvania, five in Michigan, two in Ohio, and one in Minnesota.
TENNESSEE SUSPENDS NECC LICENSE
All but eight of the 23 states that received suspect medications from the Massachusetts specialist pharmacy have reported at least one case of fungal meningitis, a rare and deadly disease that has proven difficult to treat.
The suspect lots of steroid were shipped to 76 facilities in 23 states, including two locations in Pennsylvania.
"We have been working directly with the clinics to ensure that patients who received these injections are monitored and receive any necessary follow-up," said Acting Pennsylvania Secretary of Health Michael Wolf.
Health authorities have said that nearly 14,000 people nationwide have received injections from the potentially contaminated medication originally linked to the outbreak.
Tennessee, the state worst affected with 53 cases and six deaths, suspended NECC's license there on Monday. NECC had already surrendered its license to operate in Massachusetts and halted operations. It also recalled all of its products, including three lots of steroid that tested positive for fungus contamination.
A list of recalled NECC products on the FDA website ran 70 pages long. here
It contained drugs for dozens of therapeutic categories, including pain medicines, antibiotics, eye drugs, hair restorers and skin care products.
At St. Thomas hospital in Nashville, Tennessee, more than 275 people have undergone spinal tap tests, a painful procedure to determine if they have meningitis. Thirty-three of them were infected.
In Tennessee's first lawsuit against NECC, Janet Russell, 71, claimed she contracted fungal meningitis after receiving one injection of methylprednisolone for back pain on August 30 at St. Thomas' Outpatient Neurosurgery Center.
The lawsuit claims that as a result, she suffers pain, the effects of a stroke, permanent disability, and emotional distress and will need ongoing medical treatment. Her husband of 53 years filed the lawsuit with her on Monday.
She is currently in the hospital's intensive care unit, her attorney said.
NECC is being investigated by federal and state authorities. Pharmacy company Ameridose, which shares common ownership with NECC, has suspended operations.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis is not contagious.
The outbreak has raised questions about how the pharmaceuticals industry operates. NECC engaged in a practice called drug compounding that is not regulated by the FDA, which generally oversees drug makers.
In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient's need.
A Reuters investigation found that NECC solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer showed.
State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products.
U.S. Senator Richard Blumenthal of Connecticut called for an immediate criminal investigation of NECC and its officers and employees. "The scope of this disaster, which only increases by the day, is a call to action for increased federal oversight of these unauthorized drug manufacturers masquerading as compounding pharmacies," he said in a statement.
Several states, including Michigan, Massachusetts, Indiana, Minnesota and Ohio, are investigating the company.
The 15 states reporting cases of meningitis are Tennessee, Michigan, Pennsylvania, New Hampshire, Illinois, Indiana, Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina, Virginia, Ohio and Florida.
(Additional reporting by Michele Gershberg in New York and David Morgan in Washington; Editing by Vicki Allen)
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised
Archive of Updates on Fungal Meningitis Outbreak
NECC press release and a complete list of the firm's compounded products.
[10-15-2012] As a result of FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility, on October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. A complete list of all products subject to this recall can be accessed here. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.
Also as a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.
FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these three infections were, in fact, caused by an NECC product
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. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here.
FDA Advice to Healthcare Practitioners
The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. Based on the new information described above, out of an abundance of caution, FDA advises you to follow-up with patients for whom you administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. 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.
You should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms.
The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).
The FDA recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary.
Clinicians 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.
Health care professionals 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.
|<< 前記事(2012/10/11)||ブログのトップへ||後記事(2012/10/23) >>|
|<< 前記事(2012/10/11)||ブログのトップへ||後記事(2012/10/23) >>|