The British Medical Journal has published three reports and one editorial criticizing the way Pradaxa (dabigatran) was approved, and is advising drug dosing in the interest of patient safety.
Boehringer Ingelheim’s Pradaxa is prescribed to patients who have nonvalvular atrial fibrillation (AF). The drug was the first new oral anticoagulant to hit the market in an effort to supersede warfarin, an older anticoagulant. One of Pradaxa’s main selling points was that, unlike warfarin, it does not require drug monitoring. The BMJ reports allege that the manufacturer hid information showing that monitoring would significantly benefit the safety profile of the drug in order to maintain this claim. Continue reading
Some protein powder makers are reportedly adding less expensive ingredients to their products to can trick a protein-content test into registering a higher protein concentration that the product actually has.
The practice – called “nitrogen spiking” or “amino acid spiking” – yields misleading results on a test that determines the protein content of the product by measuring nitrogen released as ammonia. The American Herbal Products Association (AHPA) says U.S. Food and Drug Administration (FDA) regulations for supplements allow protein to be calculated as a factor of nitrogen content, but the sources of nitrogen do not have to be included. The AHPA feels the industry needs a “defined standard” of what substances should be included in measuring nitrogen content and therefore contribute to the powder’s supposed protein content.
Amino acid spiking increases a product’s nitrogen content and consumers do not receive the full complement of genuine, high-quality, natural protein they are paying for. While isolated amino acids are technically not “protein,” they contribute to the total protein amount.
Companies suspected of amino acid spiking include Body Fortress, ProSupps. MusclePharm Arnold Series, 4 Dimension Nutrition, Designer Whey, Mutant Nutrition, Top Secret Nutrition, Gaspari Nutrition, Giant Sports Nutrition, Infinite LabsL, and Beast Sports Nutrition. Arginine, creatine, glycine, and taurine are among the amino acids used in spiking. While amino acids do offer benefits in the products, they should not be counted in the protein content.
The FDA regulates ingredients in dietary supplements, though they fall under different regulations than conventional foods and drug products. The FDA takes action against adulterated or misbranded dietary supplement products after they reach the market but has no regulatory power before a product is marketed. The FDA has taken action against manufacturers whose supplements contain hidden drug ingredients or do not contain the listed type and amount of an ingredient. Adulterated or misbranded supplements can be dangerous to health, the FDA warns.
The U.S. Food and Drug Administration (FDA) advised that it is alerting health care professionals and consumers regarding a recall of all non-expired drug products meant for sterile use and sold and distributed by Unique Pharmaceuticals Ltd., located in Temple, Texas.
The recalled products include Lot Number 86513, N-Acetyl Cysteine 20 percent, and all other non-expired, purportedly sterile drug products.
Health care professionals are being advised to immediately check their medical supplies and to quarantine all sterile drug products from Unique Pharmaceuticals. These recalled drugs must not be administered patients as the products may be contaminated. What’s more, administration of a non-sterile drug product that is meant to be sterile may lead to serious and potentially life-threatening infections, and even death. Continue reading
A new study has revealed that, based on insurance claim information, bladder cancer patients may not benefit from robotic surgery for their bladder removal procedures.
In fact, according to Fierce Medical Device, patients experienced similar complication rates and hospital stay lengths regardless of if their bladders were removed by robot or the more traditional open procedure. The study involved 118 patients from Memorial Sloan Kettering Cancer Center from 2010 and 2013 and the participants were randomly chosen for open or robotic surgery. The Sloan Kettering researchers’ data was peer-reviewed, a New England Journal of Medicine (NEJM) spokeswoman wrote in an email, according to The Wall Street Journal. Continue reading
Acetaminophen is a common pain reliever and fever reducer commonly used to treat back pain, but a newly published study in The Lancet has found that it is no better than a placebo for this purpose. Acetaminophen is sold under brand names such as Tylenol, Anacin and Panadol.
The study involved 1,643 people who suffered from acute lower back pain. The researchers randomly assigned these participants into one of three groups who received two boxes; one box was labeled “regular” and the other “as-needed”. The first group received two boxes, with 500-milligram acetaminophen tablets in the “regular” box as well as acetaminophen in the second “as-needed” box. The second group received one regular box of acetaminophen and an as-needed box containing a placebo. The third group received two boxes of placebo. Continue reading
For police officers and others who took part in World Trade Center rescue and recovery efforts and now suffer cancer caused by toxic exposure, a deadline to register for compensation through the James Zadroga September 11th Victim Compensation Fund (VCF) is less than three months away.
The New York City Patrolmen’s Benevolent Association has alerted its members that those who were diagnosed on or before October 12, 2012 with one of the cancers first recognized by the VCF on that date must register by October 12, 2014, according to The PBA Beat. The newsletter says that members diagnosed on or before October 21, 2013 with prostate cancer must register by October 21, 2015. Members who were diagnosed on or before February 18, 2014 with a “rare cancer” as defined by the WTC Health Program must register by February 18, 2016, and members diagnosed with any of the recognized cancers after the relevant cut-off date above may register up to two years after the date they became ill, but no later than October 3, 2016. Continue reading
According to a study published this week in the Journal of the American Medical Association, the power morcellator, a surgical tool used in about 50,000 hysterectomies a year, may spread cancer.
In a power morcellation procedure, a device cuts uterine tissue into pieces that can be removed through small incisions made during minimally invasive surgery, The New York Times reports. Morcellation is also used to remove fibroid tumors. But recent reports indicate that when a morcellator slices into cancerous tumors the doctor didn’t know existed, the cancer cells can be spread through the woman’s abdomen. And the JAMA study found that undetected tumors are more common than many experts had thought. Continue reading
St. Jude Medical’s Riata and Riata ST defibrillator leads were recalled in the past due to “lead externalizations”, a defect where the wires protrude through the insulation. Now, a Danish study has linked this issue to a higher risk of electrical failures that worsens with time. Continue reading
Late last Friday, a Florida jury awarded $26 billion in punitive damages against R.J. Reynolds Tobacco Company in the death of a chain smoker who died of lung cancer at age 36.
The suit was brought by Cynthia Robinson, widow of Michael Johnson Sr., who died in 1996. He had smoked for more than 20 years, beginning around age 13. The lawsuit argued that Reynolds had deliberately concealed the health hazards of Kool cigarettes, Johnson’s brand, The New York Times reports. The jury first awarded $17 million in compensatory damages and then the staggering $23.6 billion in punitive damages. Continue reading
California officials have shut-down 11 oil and gas waste water injection sites in the Central Valley and ordered a review of more than 100 others, fearing that energy companies may have been pumping fracking fluids and other toxic waste into drinking water aquifers.
The Division of Oil and Gas and Geothermal Resources issued cease and desist orders on July 7 to seven energy companies warning that they may be injecting waste into drinking water sources. The waste water disposal “poses danger to life, health, property, and natural resources,” the investigative journalism organization ProPublica reports. Continue reading