FDA officials 'deeply concerned' about inaccurate lead exposure tests

  • FDA officials 'deeply concerned' about inaccurate lead exposure tests

FDA officials 'deeply concerned' about inaccurate lead exposure tests

US health agencies are warning that certain tests for lead poisoning may not be accurate. The CDC recommends that children younger than 6 years old along with and pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.

Healthcare professionals and public health laboratories should discontinue using Magellan's LeadCare System Testing System with venous blood samples, due to concerns about inaccurately low results, said the FDA in a safety communication.

And the FDA says it's aggressively investigating why these tests can give inaccurate results. The agency is advising that lead tests using blood samples that are drawn from a vein should no longer be used.

Shuren said that the FDA first became aware of the issue during a review of a 510 (k) premarket submission for a new LeadCare product received from Magellan in March 2017. In addition, other types of lead testing methods are not believed to be affected.

Certain tests used to detect lead exposure could provide inaccurate results for some children and adults in the United States, U.S. regulators warned on Wednesday.

The Food and Drug Administration and the Centers for Disease Control and Prevention said the tests in question were made by Magellan Diagnostics, a leading testing company. The most common way to check children's blood is through a finger or heel stick. The company stated that only 10 percent blood tests are carried out with blood drawn from the veins and accounts for about $1.8 million of Magellan Diagnostic's revenue.

The FDA and CDC say women and parents should ask their doctor whether they need to be tested again.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the FDA investigation is now in its early phases, so most people are not likely to be affected.

But he said while the FDA and CDC are in the "early stages" of their investigation, they did not want to delay issuing this warning to the public. But he remains deeply concerned because a "root cause" of the problem has not yet been found. Low-level lead exposure, even at blood lead concentrations below 5 g/dL, can increase the risk of intellectual and academic disabilities in children, and is linked to higher rates of behavioral disorders such as hyperactivity and attention deficits, and lower birth weight. But if those levels are elevated, a follow up test is done with blood drawn from the arm.

The government officials noted that lead exposure can cause damage in almost every system in the body and produces no symptoms.

"There is no safe level of lead exposure for children, and the best "treatment" for lead poisoning is to prevent lead exposure before it happens", said Jennifer Lowry, chair of the American Academy of Pediatrics Council on Environmental Health, according to The Washington Post.