Boehringer Ingelheim GmbH, which markets and manufactures Pradaxa, has been charged with a nearly $1 million fine, according to a recent ruling. The fine was levied for the drug maker’s withholding or failing to preserve files sought in Pradaxa litigation, according to the judge’s ruling.
The “countless” files were sought by patients who have brought lawsuits over the blood thinner, Pradaxa, Bloomberg News reports. U.S. District Judge David Herndon, located in East St. Louis, Illinois, is overseeing more than 1,700 consolidated lawsuits that have been filed over allegations that Pradaxa caused excessive and, in some cases, fatal bleeds. Judge Herndon concluded that Boehringer executives acted “in bad faith” when they neglected to ensure that the documents and files in question, which involved the development and marketing of Pradaxa, were preserved. Continue reading
The U.S. Consumer Product Safety Commission (CPSC), in cooperation with IKEA North America and Health Canada, has announced the recall of children’s wall-mounted lamps due to strangulation hazard.
A 16-month-old child in a crib died after becoming entangled in the lamp’s cord. In another incident, a 15-month-old child in a crib became entangled in the lamp’s cord and nearly strangled. In both incidents, the child pulled the lamp cord into the crib, according to the CPSC news release. Continue reading
Some drugs widely used to control stomach acid may increase the risk of a serious vitamin deficiency, a new study suggests.
A research team found that people who were diagnosed with vitamin B12 deficiency were more likely to be taking proton-pump inhibitors (PPIs) and histamine 2 receptor antagonists (H2RAs) than those who did not have the deficiency, Reuters reports. PPIs and H2RAs are used to treat acid reflux and peptic ulcers. Common PPIs include Prilosec (omeprazole), Nexium (esomeprazole), and Prevacid (lansoprazole); H2RAs include Tagamet (cimetidine), Pepcid (famotidine), and Zantac (ranitidine). Continue reading
The clash between the genetic test service company 23andMe and the U.S. Food and Drug Administration (FDA) over direct sale of gene analysis services to consumers signals a move toward stricter oversight of thousands of such tests.
The Personal Genome Test from 23andMe provides individuals with an analysis of their risk of hundreds of diseases based on DNA data from a saliva sample. Last month, the FDA moved to ban sales of the service, which has not received FDA clearance, Bloomberg News reports. Genetic tests are in increasing demand for the purpose of diagnosing or determining disease risk and help in making treatment decisions, especially in cancer. James Evans, a geneticist at the University of North Carolina in Chapel Hill, said increased regulation is needed to make sure these tests fulfill their claims. Continue reading
New study results indicate that many drug labels still lack specific information pertaining to infants, although Congress passed legislation encouraging drug studies that focus on medications used in children.
The research study, published online yesterday in the journal JAMA Pediatrics, focused on neonates—infants up to 28 days of age—who are at high risk for adverse effects from drugs, HealthDay reports. In a background to the study, the authors note that, in the early days of life, infants’ bodies work in very unique ways. Because of this. analysis of data compiled for older patients does not provide a realistic prediction of how those drugs might affect neonates. Continue reading
New study results indicate that almost every hour a child is brought to a hospital emergency room with an injury associated with a high chair, and the risk seems to be rising.
From 2003 and 2010, an average of about 9,500 infants and toddlers were brought to emergency rooms with high-chair-related injuries, Reuters Health reports. Injuries increased toward the end of that period, said Dr. Gary Smith, the study’s senior author, and emergency departments were seeing “around 11,000 kids” every year toward the end of the seven-year period. Continue reading
A study by the U.S. Centers for Disease Control and Prevention (CDC) shows a link between tainted drinking water at the Camp Lejeune Marine Corps base in North Carolina and increased risk of serious birth defects and childhood cancers.
The long-awaited study was released last Thursday by the CDC’s Agency for Toxic Substances & Disease Registry, the Associated Press (AP) reports. The CDC surveyed the parents of 12,598 children born at Camp Lejeune between 1968 and 1985, the year most contaminated drinking water wells were closed. The study was designed to see if there was a link between exposure to certain chemicals and certain health problems that developed later. The CDC confirmed 15 cases of spina bifida and anencephaly, 24 cases of oral clefts, and 13 cases of cancer. Continue reading