Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.
A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Continue reading
The European Medicines Agency (EMA) instituted a ban on about 700 generic medicines that were approved based in part on what were said to be flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India.
The U.S. Food and Drug Administration (FDA) said it found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but the FDA said it supports Europe’s ban, according to Outsourcing-Pharma.com. The banned medicines include different formulations and strengths. Continue reading
On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain.
The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all in the same class and work by making more insulin available to the body. Continue reading
The U.S. Food and Drug Administration (FDA) is implementing whole genome sequencing to quickly detect and stop the spread of foodborne illnesses, Business Insider reports. The process offers huge advantages over the previous method, where samples from sick patients were tested to see if infections were caused by the same pathogen. Once enough matches appeared, the sick individuals were interviewed by epidemiologists to see if a common food was responsible for the outbreak. This method, however, does not conclusively find the cause and is time-consuming. “While all of this was going on, more contaminated product was getting out into the public,” said Dr. Steven Musser, deputy director for scientific operations at the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, according to Business Insider.
The FDA is now having state and federal labs map out the exact genome of strains of foodborne pathogens such as Listeria and Salmonella. The National Institutes of Health houses a public database, known as GenomeTrakr where all the sequences are uploaded. Whole genome sequences allows scientists to distinguish a pathogen from related species, as well as slight mutations within the same strain. Continue reading
FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims
Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels.
ITG Brands LLC makes Winston cigarettes, labeled additive-free; Santa Fe Natural Tobacco Company’s Natural American Spirit cigarettes are labeled additive-free and natural; and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman cigarettes are labeled natural, WebMD reports. The companies may not represent “implicitly or explicitly . . . that the product presents a lower risk of tobacco-related disease,” the FDA news release says. Continue reading
Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.
The Food and Drug Administration (FDA) notice lists five devices included in the recall: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function, Medscape reports. Continue reading
The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death.
These side effects can occur as early as the first weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Aspirin is also an NSAID, but the revised warning does not apply to aspirin.) The OTC drugs covered by the revised warning in this group are used for the temporary relief of pain and fever and the prescription drugs are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medicines with the same active ingredient. Continue reading
The Food and Drug Administration (FDA) is investigating the potential risks of using medicines with codeine to treat coughs and colds in children and has issued a Drug Safety Communication about such medicines. There is a potential for serious side effects, including slowed or difficult breathing.
Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines, according to the FDA. In April, the European Medicines Agency (EMA) announced that codeine must not be used to treat coughs and colds in children younger than 12. The EMA also said codeine is not recommended for children and teens between 12 and 18 who have breathing problems, such as asthma. The FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Continue reading
U.S. Sen. Richard Blumenthal has proposed new legislation to regulate the sale of used cars with unrepaired recalls with what he says can be lethal safety defects.
Blumenthal, the senior senator from Connecticut, is concerned about cars sold by CarMax. “CarMax advertises that all its vehicles must pass a rigorous ‘125 point inspection,’ but no inspection that routinely ignores outstanding safety recalls can be called ‘rigorous,'” Blumenthal said, according to television station WFSB. “Regardless of whether they are buying a new or used car, all consumers deserve to know they are buying a safe car.” Continue reading
Florida U.S. Rep. Bill Posey recently presented evidence to Congress that the Centers for Disease Control and Prevention (CDC) destroyed data linking the MMR vaccine, (measles, mumps and Rubella) and autism.
Posey based his charges on the allegations from Dr. William Thompson, a 17-year veteran of the CDC, who became a whistleblower and charged that he was pressured to manipulate data in order to conceal possibly harmful side effects of the MMR vaccine, WND (WorldNetDaily) reports. Continue reading