The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report.
In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report that raises concerns about possible “mitochondrial toxicity” associated with fluoroquinolones, which are marketed under brand names including Levaquin and Cipro and the generic form levofloxacin. These powerful antibiotics have been used to treat anthrax cases and are used for pneumonia and kidney infections. Continue reading
The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the lower back and in surgeries to repair broken tibia. The kit InductOs is sold as contains its active ingredient dibotermin alfa and an absorbable collagen sponge (ACS) manufactured by Integra LifeSciences.
Regulatory Affairs Professionals Society (RAPS) reports that the contamination problems were from a site in the United States that manufactures the ACS in InductOs. In January 2014, inspectors identified “a number of major deficiencies” and Integra was issued a corrective action plan. Because of the contamination issues, the company was not allowed to import the sponge to the EU until inspectors could return and “assess the progress in eliminating the major deficiencies”. Continue reading
On July 23, the Consumer Product Safety Commission (CPSC) announced the recall of about 79,000 UPPAbaby strollers in the U.S. and Canada because the foam covering of the bumper bar could pose a choking hazard.
The recall includes the UPPAbaby 2015 CRUZ and 2015 VISTA strollers and 2015 RumbleSeats. The child can bite off and choke on the foam covering of the bumper bar. Continue reading
Infants and children switched from older to newer models of Medtronic Shiley Neonatal and Pediatric Tracheostomy tubes developed breathing difficulties and this prompted Medtronic Inc. to recall 8,192 of the tubes in May.
In its recall announcement, the Food and Drug Administration (FDA) said there had been 12 reports of serious injuries associated with the Shiley tubes, but no deaths have been reported to date. Continue reading
Berkeley’s cell phone ordinance, which requires retailers to warn consumers about the potential risk of radiation with cell phones, is the first measure of its kind to be passed. In May, the City Council unanimously passed the ordinance, titled Right to Know. The law goes into effect next month and warns consumers that “you may exceed the federal guidelines for exposure” to radiofrequency radiation by placing a cell phone into a bra or in a pants pocket. The warning also states that “The potential risk is greater for children” according to the New York Times.
Berkeley’s ordinance brings up questions about whether or not other cities will adopt a similar law. The city is known for its progressive actions, and has passed legislation that are sometimes seen as radical but are later implemented in other places, including health benefits for domestic partners, smoking bans, Styrofoam bans and creating sanctuaries for illegal immigrants. “If you can get it passed in Berkeley, you have a beginning,” said Berkeley Council member Susan Wengraf, according to NYT. “If you can’t, forget it, or come back three years later.” Continue reading
The warning labels on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) are being strengthened to reflect the the risk of heart attack and stroke, the U.S. Food and Drug Administration (FDA) announced. The agency already warned of this risk in 2005, but has updated the label after an expert panel reviewed new safety data. NSAIDs, which are available in many over-the-counter (OTC) products such as Advil, Motrin and Aleve, are widely used. Raising awareness about potential risks is important and wide-reaching.
The revised warning says that the painkillers may increase the risk of stroke or heart attack in the first few weeks and that the risk can increase when they are used for longer periods. The risk also increases with higher doses. The revised label will also reflect that patients with or without heart disease or other risk factors can face an increased risk of stroke or heart attack with NSAID use, although patients with risk factors or heart disease are more likely to experience these events. The FDA notification states that “A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.” Continue reading
Recent studies have shown that gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) deposit in the brain of some patients who have repeated scans. The Food and Drug Administration (FDA) is investigating possible health risks of such deposits.
Recent publications in the medical literature—including an article published in March in Radiology—have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration of the agent. The FDA says it is not known whether gadolinium deposits are harmful or can lead to adverse health effects. Continue reading
The use of antibiotics was linked to an increased risk of cancer in a study conducted by researchers from Rutgers University, University of Pennsylvania and Nemours A.I. duPont Hospital for Children. Findings showed that children who were exposed to antibiotics were twice as likely to develop juvenile arthritis compared to those who were not. As additional courses of antibiotics were taken, the risk increased; the risk was strongest within one year of taking antibiotics. The study was published in the journal Pediatrics.
Researchers conducted the study in light of evidence suggesting that children may be more likely to develop chronic diseases, including inflammatory bowel disease, when exposed to antibiotics. “Antibiotics are one of the better known disruptors of human microbial communities,” said lead author Daniel Horton, a postdoctoral research fellow working in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School and biomedical informatics master’s degree candidate in the Rutgers School of Health Related Profession. Continue reading
Medtronic has recalled nearly 2,000 units of its MiniMed 640G insulin pumps, according to a notification posted on the U.S. Food and Drug Administration’s (FDA’s) website. The device was distributed in the following 10 European countries: Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Medtronic intends to submit the pump for PMA submission later this year, Fierce Medical Devices reports.
According to the recall notice, there may be instances where “the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.” The recall was designated as Class 2 by the FDA, meaning that exposure to the recalled device might lead to temporary or reversible adverse events or that there is a low risk of serious events. Continue reading
Fiat Chrysler Automobiles could pay up to $105 million in fines and penalties and must buy back defective vehicles in an agreement with the federal government that will also require an independent monitor to oversee future vehicle recalls.
The automaker may have to buy back more than half a million vehicles with defective suspension parts if owners wish to sell those vehicles back to Chrysler, Fortune reports. Continue reading