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FDA Medwatch Alert: LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

Posted 9 days ago by Drugs.com

ISSUE: The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the CDC to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples. The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities and the CDC, and will update this safety c ... Read more

Related support groups: Diagnosis and Investigation, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests

Posted 9 days ago by Drugs.com

May 17, 2017 – The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested. “The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The agency is aggressively investigating this complicated issue to determine the cause of th ... Read more

Related support groups: Diagnosis and Investigation, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Some Lead Poisoning Tests May Be Faulty

Posted 9 days ago by Drugs.com

WEDNESDAY, May 17, 2017 – Lead tests made by Magellan Diagnostics may yield inaccurate results for some children and adults, U.S. health officials warned Wednesday. Parents of children younger than 6 years old, pregnant women and nursing mothers who have been tested for lead exposure using these tests should consult a health care provider about whether they should be retested, the officials said. Data indicate that when all four of Magellan's lead testing systems – LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra – are performed on blood drawn from a vein, they may give results that are lower than the actual level of lead in the blood. However, lead testing using blood taken from a vein is not widespread. Most testing is done with finger pricks and heel pricks, the officials said. "The FDA is concerned that Magellan lead tests that use blood drawn from a vein may provide ... Read more

Related support groups: Diagnosis and Investigation, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Shooting Ranges Pose Hidden Risks: Study

Posted 15 Apr 2017 by Drugs.com

FRIDAY, April 14, 2017 – Residue from the firing of lead bullets poses a health risk at shooting ranges, a new study contends. With lead bullets, lead fragments and fumes are discharged at high pressure when a gun is fired. Shooters can breathe in the lead, and particles can stick to their hands and are swallowed when they eat or smoke, the study authors said. Women of childbearing age are at especially high risk because the lead is stored in their bones where it substitutes for calcium. If they become pregnant, their fetus can take in the lead, which may cause serious brain and nerve damage, the scientists said. Women can also pass lead to their infants through breast milk, the researchers added. The review of 36 articles on the topic was published online recently in the journal Environmental Health. Although the health dangers of lead have long been known, little attention has been ... Read more

Related support groups: Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Lead Exposure as Child, Lower IQ as Adult?

Posted 28 Mar 2017 by Drugs.com

TUESDAY, March 28, 2017 – Adults who had high levels of lead exposure during childhood may have lower IQs and poorer-paying jobs as adults, a new study suggests. Researchers followed more than 500 New Zealanders from birth in the 1970s to adulthood. When the study began, New Zealand had some of the highest gasoline lead levels in the world. Breathing in leaded gas fumes, or playing with soil near busy roads, could heighten lead exposure since dust particles containing lead comes from car tailpipes, the researchers said. Blood samples of the study participants collected at age 11 were tested for lead. Assessments of thinking and memory skills were also regularly conducted during the study. At age 38, those participants who had more than 10 micrograms of lead per deciliter of blood at age 11 had IQs an average of 4.25 points lower than those with lower lead levels as kids. They also had ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Toxic Metals Found in E-Cigarette Liquid

Posted 8 Feb 2017 by Drugs.com

WEDNESDAY, Feb. 8, 2017 – Electronic cigarette liquids can contain high levels of toxic and potentially cancer-causing metals, a new study suggests. "We do not know if these levels are dangerous, but their presence is troubling and could mean that the metals end up in the aerosol that e-cigarette users inhale," said study leader Ana Maria Rule, of Johns Hopkins Bloomberg School of Public Health in Baltimore. Rule is an assistant scientist in the department of environmental health and engineering. She and her colleagues analyzed the liquid of five brands of so-called first-generation e-cigarettes, which resemble traditional cigarettes. (Newer e-cigarettes look like small cassette recorders with mouthpieces.) The researchers found liquids in those brands contained the heavy metals cadmium, chromium, lead, manganese and nickel. These metals are toxic when inhaled, the researchers said. In ... Read more

Related support groups: Smoking, Smoking Cessation, Nicotine, Poisoning, Nicorette, Nicoderm CQ, Nicotrol Inhaler, Commit, Toxic Reactions Incl Drug and Substance Abuse, Habitrol, Lead Poisoning, Nerve Agent Poisoning, Nicotrol NS, ProStep, Nicotrol TD, Nicorelief, Nicorette DS

FDA Suggests Limits on Lead in Cosmetics

Posted 23 Dec 2016 by Drugs.com

FRIDAY, Dec. 23, 2016 – The U.S. Food and Drug Administration has suggested setting a limit on how much lead can be in cosmetics ranging from lipstick and eye shadow to blush and shampoo. Although it does not have the authority to enforce such a limit, the FDA recommended in a draft guidance issued Thursday that cosmetics not contain more than 10 parts per million (ppm) of lead. Lead occurs naturally in the environment, but high levels can harm almost every organ in the body. Children and pregnant women are particularly susceptible to its harmful health effects, according to the U.S. Environmental Protection Agency. In crafting its guidance on lead limits in cosmetics, the FDA tested hundreds of products for lead. "Although most cosmetics on the market in the United States generally already contain less than 10 ppm of lead, a small number contained higher amounts," the FDA said. ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Some Mexican Ceramics Can Serve Up Lead Poisoning

Posted 20 Oct 2016 by Drugs.com

THURSDAY, Oct. 20, 2016 – A charming ceramic reminder of a Mexican vacation could end up giving you lead poisoning, a new study warns. Exposure to high concentrations of lead – often found in glazes that line traditional Mexican ceramics, cookware and dishware – can be toxic after extended periods of handling, Canadian researchers report. The issue has long been on the radar of public health professionals, but was highlighted recently by the lead poisoning of a 55-year-old Canadian woman. She frequently used ceramic dishware picked up in Mexico. "Every time she poured hot water into her mug, lead was seeping out of the glaze and into her tea," explained study lead author Dr. Michael Fralick. He's a general internist at the University of Toronto and a research fellow in pharmacoepidemiology at Harvard University. According to the case report, the woman had been repeatedly hospitalized ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Flint Water Crisis Taking High Toll on Health, Productivity

Posted 8 Aug 2016 by Drugs.com

MONDAY, Aug. 8, 2016 – The water crisis in Flint, Mich., has cost $395 million in lost productivity, increased welfare use and criminal justice spending, according to a new study. That estimate does not include the $58 million spent on medical care and supplying clean water, wrote Peter Muennig in a letter published in the August issue of the journal Health Affairs. He is a professor of health policy and management at Columbia University in New York City. Flint's water system was contaminated with lead after the city switched its source from Lake Huron to the Flint River in April 2014 to save money. Using U.S. Centers for Disease Control and Prevention data, Muennig estimated that Flint, with more than 8,000 cases, accounted for about 5 percent of lead poisonings in the United States between April 2014 and April 2015. According to the CDC, no safe level of lead in children has been ... Read more

Related support groups: Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Much-Maligned Pigeon May Be a Lead Detective

Posted 21 Jul 2016 by Drugs.com

WEDNESDAY, July 20, 2016 – Though pigeons are generally considered a city-dwelling nuisance, researchers have found that these "rats of the sky" can be used to monitor levels of lead and other toxic compounds in cities. Blood samples taken from hundreds of sick or injured pigeons in New York City between 2010 and 2015 showed that their lead levels rose in the summer. Those findings correlated to what happened with lead levels in blood samples from children. Zip codes in the city with high lead levels in pigeons also had some of the highest levels of lead in children, the study found. "Pigeons breathe the same air, walk the same sidewalks, and often eat the same food as we do. What if we could use them to monitor possible dangers to our health in the environment, like lead pollution?" said study leader Rebecca Calisi. Calisi, an assistant professor of neurobiology, physiology and ... Read more

Related support groups: Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Health Tip: Keep Lead From Your Home

Posted 8 Jul 2016 by Drugs.com

-- Children exposed to even small amounts of lead can face a host of physical and mental development problems. The U.S. Centers for Disease Control and Prevention suggests these preventive tips: Test your home for lead. If your home was built before 1978, make sure your child cannot reach peeling paint. If you're renovating your older home, children and pregnant women should move out during construction. If you're cleaning up an area with lead, make sure it's carefully closed off from areas where children spend time. Frequently wash your child's toys and hands to help wash away any lead gathered from the home or nearby soil. Take off shoes when re-entering the home, and regularly wet mop floors and wipe down windowsills. Don't let children play in soil. Plant grass or cover with mulch, sand or wood chips. Read more

Related support groups: Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Flint's Lead-Contamination Crisis 'Entirely Preventable'

Posted 24 Jun 2016 by Drugs.com

FRIDAY, June 24, 2016 – Analysis of blood samples from young children of Flint, Mich., shows they had much more lead in their blood when the city used local drinking water in an effort to cut costs, a new U.S. government study reveals. A series of blood samples showed kids younger than 6 were nearly 50 percent more likely to have elevated blood lead levels when the city used the Flint River for drinking water instead of the Detroit water system, researchers from the U.S. Centers for Disease Control and Prevention concluded. The percentage of kids with high lead content returned to previous levels once the city switched back to the Detroit system. The reason for the lead contamination? Inappropriate corrosion control measures, investigators said. "This crisis was entirely preventable, and a startling reminder of the critical need to eliminate all sources of lead from our children's ... Read more

Related support groups: Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

No Amount of Lead Is Safe for Kids

Posted 20 Jun 2016 by Drugs.com

MONDAY, June 20, 2016 – No amount of lead exposure is safe for children, and stricter regulations are needed to protect youngsters from this serious health threat, the American Academy of Pediatrics (AAP) says. There's growing evidence that even low levels of lead exposure previously considered safe can cause permanent mental, behavioral and school problems in children, according to the pediatricians' group. Identifying and eliminating lead sources before exposure occurs is the only reliable way to protect children from this danger, the AAP said. This requires stricter regulations, more federal resources and joint action by government officials and doctors, according to the updated AAP recommendations. "We now know that there is no safe level of blood lead concentration for children, and the best 'treatment' for lead poisoning is to prevent any exposure before it happens," Dr. Jennifer ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Lead Poisoning, Lead Poisoning - Mild, Lead Poisoning - Severe

Take Precautions to Prevent Child Poisonings

Posted 22 Apr 2016 by Drugs.com

FRIDAY, April 22, 2016 – From detergents to prescription medication, many common household items can poison children, an emergency medicine physician warns. Prescription drugs are one of the main threats, said Dr. Wally Ghurabi, medical director of the Nethercutt Emergency Center at the University of California, Los Angeles Medical Center. Recently, three middle school students were treated in the ER after taking the anti-anxiety drug Xanax they had found at home, Ghurabi said. "They spent 12 hours in the emergency department having their stomachs pumped and being monitored for adverse reactions," he said in a medical center news release. "It was serious." Drugs intended for adults can be toxic to children, he noted. "A common medication used to treat diabetes can stay in one's system for 96 hours – up to four days. While its purpose is to lower an adult's blood sugar, in a child it ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Lead Poisoning, Lead Poisoning - Mild, Mercury Poisoning

60,000 U.S. Kids Treated for Accidental Medicine Poisoning a Year

Posted 21 Mar 2016 by Drugs.com

MONDAY, March 21, 2016 – Nearly 60,000 children in the United States are accidentally poisoned by medicines each year, a new report says. That's the equivalent of four busloads of children – or one every nine minutes – arriving at emergency departments every day because of medicine-related poisoning, according to Safe Kids Worldwide. And nearly every minute each day a poison control center receives a call about a child who got into medicines, the report notes. "We want parents and caregivers to remember that the first line of defense in preventing medicine poisoning is the family," Kate Carr, president and CEO of Safe Kids Worldwide, said in a news release from the group. Americans fill nearly three times as many prescriptions as they did in 1980 and spend five times as much on over-the-counter drugs, according to the report. With so many medications on hand, parents and other adults ... Read more

Related support groups: Poisoning, Toxic Reactions Incl Drug and Substance Abuse, Acetaminophen Overdose, Lead Poisoning, Iron Poisoning, Mercury Poisoning

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