Factbox: What the public should know about meningitis outbreak

Thu, Oct 11 20:03 PM EDT (Reuters) - Many Americans are concerned about a deadly outbreak of a rare form of meningitis that may be tied to contaminated steroid medication used mainly for injections to reduce back pain. Here is some information from a U.S. Centers for Disease Control and Prevention briefing on Thursday: ** Nearly 14,000 people may be at risk of contracting meningitis after receiving injections into the back or joints from steroid medication that may have been contaminated with a fungus. Of those, more than 12,000, or 90 percent, have been contacted by health authorities since the product was recalled on September 26. Health authorities are trying to find the others. ** The product, called methylprednisolone acetate, was shipped to 76 facilities in 23 states and is used mainly for epidural injections to alleviate back pain, or for injections to joints such as the knee, shoulder or ankle. The CDC has posted a map with a list of facilities that received the potentially contaminated steroid at http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html. The 23 states are California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia, the CDC said. ** Fourteen people had been confirmed dead of meningitis in the outbreak as of Thursday and 169 people have been stricken with meningitis after receiving an injection. One other person, in Michigan, has contracted an infection in the ankle after receiving an injection, but tests are not yet conclusive for a fungal infection. Cases have been discovered in 11 states and deaths have occurred in six states - Tennessee, Michigan, Florida, Indiana, Maryland and Virginia. ** Patients who have had an epidural steroid injection or injection in a joint at a clinic or practice associated with any of the facilities listed by the CDC since May 21, 2012, should talk to their doctors as soon as possible if they are suffering characteristic symptoms. Those include worsening headaches, fever, sensitivity to light, stiff neck, weakness or numbness and/or slurred speech. Patients normally experience symptoms within one to four weeks after the injection, but it could be longer. The median time after injection to when symptoms begin is two weeks. The longest period among the cases seen so far has been 42 days, and health experts said patients should be vigilant for months after an injection. ** Meningitis is an extremely serious infection of the membranes covering the brain and spinal cord. It is important to treat it quickly with anti-fungal medications in order to arrest the disease. Fungal meningitis is not contagious. ** The meningitis outbreak does not raise any concerns about other injections such as flu shots, the CDC and Food and Drug Administration said. Consumers should follow recommendations as normal for getting flu shots, which are regulated by the FDA and are completely unrelated to the medications suspected in the infections and deaths in recent weeks. SOURCES: Centers for Disease Control and Prevention website and briefing on October 11 by CDC, FDA and Massachusetts state authority on the meningitis outbreak. (Compiled by Greg McCune; Editing by Peter Cooney) ========= Woman sues company at center of deadly meningitis outbreak Thu, Oct 11 22:17 PM EDT By David Bailey MINNEAPOLIS (Reuters) - A Minnesota woman who says she received injections of the steroid at the center of a deadly outbreak of fungal meningitis in the United States on Thursday sued the company that made the suspect medication. The lawsuit, filed in U.S. District Court in Minnesota, said that Barbe Puro of Savage, Minnesota, suffered "bodily harm, emotional distress, and other personal injuries" after being injected on September 17 with doses of the steroid medication. Puro is the first apparent victim of tainted steroid injections to sue the Framingham, Massachusetts-based New England Compounding Center (NECC) - the company at the center of a meningitis outbreak that has killed 14 people. As many as 14,000 people received injections from suspect shipments of the steroid treatments produced by NECC. Representatives of the company did not immediately respond to emails and phone calls seeking comment on the lawsuit. Puro, who suffers from chronic back pain, said in the lawsuit that she suffered headaches and nausea for a week after receiving the injections at a medical clinic in Shakopee, Minnesota, a suburb southwest of Minneapolis. The Minnesota state health department told Puro last week that her injections were from the suspect medication, said her lawyer, Jeffrey Montpetit. They told her to be tested for possible fungal meningitis. Puro underwent a spinal tap and blood work and is awaiting the results of those tests, Montpetit said in a telephone interview. Puro was injured several years ago in a fall while walking a dog, he said. "The problem is they are treating for a pain issue to begin with," Montpetit said of the patients. "When they get an onset of symptoms it doesn't naturally occur to them that this is something different than what they have been dealing with." The lawsuit proposes a class comprised of Minnesota residents who received the possibly tainted injections since June this year. There have been three reported meningitis cases in Minnesota, where about 830 people were treated with the suspect steroids. The company shipped the medication to 23 states. The lawsuit is Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No. 12-2605. (Reporting by David Bailey; editing by Grant McCool and Mohammad Zargham) ======= Mon, Oct 08 21:29 PM EDT 1 of 4 By Tim Ghianni NASHVILLE, Tennessee (Reuters) - About 13,000 people in 23 states may have received steroid injections linked to a rare fungal meningitis outbreak that has killed eight people, but far fewer are likely to contract the disease, the Centers for Disease Control said on Monday. It was the first time the CDC has given an estimate of the number of patients potentially affected, having previously said only that it could be in the thousands. So far, 105 cases of the rare form of meningitis have been confirmed in nine states. In worst-hit Tennessee another person has died, bringing the national death toll to eight, the CDC and Tennessee state authorities said on Monday. The Saint Thomas Outpatient Neurosurgery Center in Nashville received about 2,000 of the 17,676 vials of potentially tainted steroid, more than any other facility in the country, said Tennessee Health Commissioner Dr John Dreyzehner. Dealing with patients who received the injections has been an "horrific experience" in many ways, said Dr Robert Latham, director of the Infectious Diseases Program at Saint Thomas. "We've seen upwards of 40 to 50 patients a day since last Monday through the emergency room that have had to be extensively evaluated," he said. The widening outbreak has alarmed health officials and focused attention on regulation of pharmaceutical compounding companies such as the one that produced the drugs - the New England Compounding Center Inc in Framingham, Massachusetts. "We anticipate finding some additional infections," said CDC spokesman Curtis Allen. He could not say if all 13,000 people had been contacted, but said efforts had been made to find them in the last few days and the recall should limit the outbreak. In Ohio, health officials said they were mobilizing community resources, including sheriff's offices, to check on patients who have received the injections. "If that means knocking on doors, then that's what they will do," Beth Bickford, executive director at the Association of Ohio Health Commissioners, said in a statement. The steroid is used as a painkiller, usually for the back. Meningitis is an infection of the membranes covering the brain and spinal cord. Patients can begin to show symptoms up to a month after injection. The potentially tainted drugs were produced as early as May 21 and shipped to 76 facilities in 23 states through September, the CDC and Massachusetts Health Department said. The company has suspended its operations while an investigation proceeds. It initially recalled the three lots of the drug, and expanded its recall on Saturday to all products compounded and distributed at its Framingham facility. The address listed in state records for the company is a rundown two-storey complex in a scruffy area of Framingham, Massachusetts, Reuters journalists who visited the site said. The journalists who tried to visit the building were ordered off the property by a security officer. A compounding pharmacy takes medications from pharmaceutical manufacturers and makes them into specific dosages and strengths for use by doctors. Complaints against the company in 2002 and 2003 about the processing of medication resulted in an agreement with government agencies in 2006 to correct deficiencies, the Massachusetts Health Department said. LIMITED FDA AUTHORITY In 2011, there was another inspection of the facility and no problems were found. In March 2012, a complaint was made about the potency of a product used in eye surgery procedures. That investigation is continuing, state officials said. The U.S. Food and Drug administration has limited authority over the operations of compounding pharmacies, which are regulated primarily by state boards that oversee the practices, licensing and certification of pharmacies and pharmacists. Compounded products do not have to win FDA approval before they are sold, and the agency has no jurisdiction over how the products are manufactured or labeled for use. The FDA probes cases of adulterated drugs in cooperation with state regulators. The FDA has tried to exert greater authority over compounded drug products. But those efforts led to federal court challenges that resulted in conflicting court rulings. Massachusetts Democratic Congressman Edward Markey said compounders fall into a federal regulatory "black hole." "If compounding is done on a large scale and is not done properly, compounders can expose large numbers of patients to health risks associated with unsafe or ineffective medications," he said in a letter to the FDA on Monday. The nine states where fungal meningitis cases have been reported are Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia. Tennessee accounted for most of the cases, with 35 and four deaths. Virginia has 23 cases and one death, Michigan 21 cases and two deaths and one person has died in Maryland. (Link to graphic http://www.reuters.com/article/interactive/idUSBRE8970TQ20121008?view=small&type=domesticNews) Fungal meningitis symptoms include fever, headache, nausea and neurological problems consistent with deep brain stroke. The steroid was sent to California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and West Virginia, the CDC said. A list of facilities that received vials from the infected lots can be found via the website www.cdc.gov . (Additional reporting by Ros Krasny, Mary Wisniewski and Greg McCune; Editing by David Brunnstrom) --