FDA
Posted on October 19, 2011 in FDA, Holistic Remedies, Recent Studies
Researchers studying vitamin E as a method to prevent prostate cancer instead found a shocking result: the supplement slightly increases the chance of prostate cancer in men. The new findings are published in the Journal of the American Medical Association.
The study was a follow-up of an earlier large-scale cancer prevention trial conducted three years ago. The trial was stopped after researchers couldn’t determine that supplements of vitamin E, selenium or a combination of the two nutrients could prevent prostate cancer. In the follow-up, about half the trial’s original 35,000-plus participants found a 17% increase in prostate cancer, compared with men who took a placebo. For every 1,000 men, 76 who took vitamin E supplements got prostate cancer, compared with 65 men who took placebo.
The study authors weren’t clear on why vitamin E appeared to raise the risk of cancer. The recommended dietary allowance of vitamin E is currently 15 milligrams for adults. Prostate cancer is the cause of about 34,000 deaths in the U.S. annually.
Posted on October 17, 2011 in Consumer Goods, FDA, Health & Medicine, Recalls
CooperVision’s Avaira Toric contact lenses were recalled in August—but many consumers suffering from corneal tears and vision problems may not be aware that the product is defective, according to reports from the FDA. CooperVision hasn’t heeded FDA requests to broaden notifications about the recall.
The lenses were recalled on August 19 after some users experienced “haziness and discomfort.†The contact lenses were sold at stores like Costco, Walmart, and Lenscrafters. Customers can log into CooperVision’s website to check the complete list of retailers and affected lots.
The FDA has contacted CooperVision and asked them to increase efforts to notify customers. According to an MSNBC report, some have ended up in the emergency room after using the defective lenses. The recall affected about 600,000 contact lenses, or 10 percent of those sold or issued as samples in the United States.
Do you wear Avaira Toric contact lenses?
Posted on October 12, 2011 in Consumer Goods, FDA, Health & Medicine, Women's Health
California became the first state to prohibit most teens from visiting tanning beds this week. The law bars those ages 14-18 from using tanning beds without an adult or legal guardian’s permission. While many states regulate how minors can use tanning facilities, California’s restrictions go further than any other state, according to the National Conference of State Legislatures.
More than 20 epidemiological studies found that one’s skin cancer risk increases 75% when a person starts using tanning beds before the age of 30. In 2009, the International Agency for Research on Cancer classified UV-emitting tanning devices as “carcinogenic to humans.â€
State Senator Ted Lieu first tried to pass the legislation in 2007, but failed to prevent teens between the ages of 14 and 18 from walking into a facility and tanning. Lieu expressed concern over the marketing tactics used by tanning facilities and the emphasis on package deals.
“I know that Snooki on the ‘Jersey Shore’ has changed to spray tanning,” Lieu told CNN in an interview. “Spray tanning has no known harmful effects, and you can get tans from lotions or cream. There are safe ways to get that brown look.”
What’s your stance on indoor tanning?
Posted on September 23, 2011 in FDA, Food, Health & Medicine, Recalls
An outbreak of listeria food poisoning tied to tainted cantaloupe has sickened more than 55 people and led to at least eight deaths, federal health officials are reporting. Local, state and federal health experts are investigating the widening outbreak tied to Rocky Ford-region brand whole cantaloupe shipped by supplier Jensen Farms of Holly, Colo.
On Sept. 14, the federal Food and Drug Administration announced a recall of cantaloupes linked to the multi-state outbreak of listeriosis. The affected cantaloupes were shipped between July 29 and Sept. 10 to at least 17 states and possibly more. There are four different strains of listeria that are being associated with the outbreak.
Although a recall was issued in mid-September, people may continue to get sick through October because of an incubation period for listeriosis. If you have some of the tainted cantaloupe, discard it even if you’ve eaten it and not become ill.
At least 43 people have been hospitalized in connection with the outbreak. More illnesses are possible, as those that occurred after Aug. 28 may not have been reported yet.
Have you discarded any Jensen Farms cantaloupe?
Posted on September 14, 2011 in FDA, Health & Medicine
Get ready to meet “the big six,†otherwise known as six potentially lethal strains of E. coli bacteria that will soon be banned from the nation’s meat supply. Beginning next spring, meat packers will be required to test for the pathogens before putting meat on grocery store shelves.
The better-known strain of E. coli 0157:H7E is linked to serious foodborne illness from tainted ground beef. E. coli 0157 was first named as an adulterant after tainted hamburger patties at a Jack in the Box restaurant sickened more than 700 people in four states and led to four deaths. After that incident, it became illegal to sell raw meat contaminated with the bacteria.
The six recently outlawed strains of bacteria produce toxins that may lead to kidney failure, serious illness, and even death. Known as Shiga toxin-producing Esherichia coli, or STECs, the group includes the strains 026, 0111, 0103, 0121, 045 and 0145. CDC officials estimate that 265,000 STEC infections occur each year in the United States, with the non-0157 strains causing up to 113,000 illnesses and 300 hospitalizations annually.
Last year, the rarer strains of E. coli were responsible for more infections in the U.S. than E. coli 0157.
Do you agree with the new legislation?
Posted on September 12, 2011 in Consumer Goods, FDA, Health & Medicine, Recalls
- Cargill Meat Solutions Corp. is recalling more ground turkey after a small amount of salmonella was found in a sample. The latest recall includes about 185,000 pounds of turkey meat.
- Australian company Cochlear is recalling its fifth generation hearing aid implant after reports that the device suddenly stopped working.
- MedTronic is recalling its SynchroMed II implantable pump models 8637-20 and 8637-40, distributed between 2004 and July 2011. The pumps may fail to deliver drugs designed to treat chronic pain.
- Honda will voluntarily recall 310,773 Pilot vehicles from the 2009 through 2011 model years in the U.S. and another 9,954 Pilots in Canada from the same model years. The effort is to inspect and potentially replace the driver’s and/or front passenger’s seat belt.
- Volkswagen is recalling more than 32,294 of its 2011 and 2012 Jettas for stainless steel tips (an appearance item installed at the port when the Jettas arrive) that may burn people.
- Target is recalling about 447,000 Embark Resistance Cords and Cord Kits. A black plastic ball attached to the resistance cord’s door anchor can unexpectedly release and strike the user, posing an injury hazard to consumers.
- About 6,100 off-road motorcycles are being recalled by KTM North America because their handlebars may slide out of their normally fixed positions and cause a crash.
- Quaker Oats Company is recalling its 8-count Quaker Chewy Smashbar Graham Pretzel Snackbars due to an undeclared milk allergen.
- Pottery Barn Kids is recalling 84,300 soft dolls named Chloe, Sophie, and Audrey because of a strangulation hazard. The hair and headband on the dolls contain loops that are large enough to fit around a child’s neck.
- Bui Natural Foods announced the voluntary recall on Saturday of its Shrimp Salad Roll and Vegetarian Salad Roll. The products contain undeclared soy and wheat.
Posted on September 5, 2011 in FDA, Health & Medicine, Recent Studies, Technology
Automated external defibrillators (AEDs) are designed to save lives by administering shocks to hearts in cardiac arrests. But what can be done when the device fails to work because of an easily preventable error? A new study finds that almost a quarter of potentially deadly AED failures are due to problems with batteries.
A study published in the Annals of Emergency Medicine tracks 1,150 AED failures over a 15-year period. Nearly one in four of those failures occurred due to problems with batteries, according to researchers who pored through nearly 41,000 reports of adverse events associated with the devices. Problems with wiring and with the pads that attached to the patient’s chest accounted for other top concerns.
According to information in the FDA’s database, 23.2 percent of the AED failures were due to battery/power failures, while 23.7 percent were due to problems with the pads or connectors. Batteries on AEDs typically last anywhere from three to five years. The devices signal when users should change the batteries with an error message.
Study authors urged that people using AEDs should report when the device fails. If the unit powers off, for instance, people can indicate whether the problem was due to the batteries or some other cause.
Do you know how to use an AED?
Posted on September 2, 2011 in FDA, Health & Medicine
The famous wrinkle-freezing Botox has just been approved for another medical use: some patients with overactive bladders can incorporate it into treatment. The new application was given the nod by the US Food and Drug Administration to treat people with multiple sclerosis or spinal cord injury who suffer from urinary incontinence and must manage it with medication or a catheter.
Clinical studies showed that the drug can be used to decrease episodes of urinary incontinence for a period of nine months. Physicians will inject Botox into a patient’s bladder, where it relaxes the muscles and allows more urine to be stored.
The controversial drug is made from a toxin produced by the bacterium Clostridium botulinum. In other forms it can cause botulism, a type of food poisoning that can often turn deadly. Botox is also approved for the treatment of eyelid twitching, chronic migraines, some types of muscle stiffness, and severe underarm sweating. It is marketed by a California-based company called Allergan.
Posted on August 30, 2011 in Consumer Goods, FDA, Health & Medicine
A weight loss product recalled in 2009 is still surfacing in stores and posing significant hazards to consumers. Pai You Guo, a supposedly natural weight-loss supplement from China, has tested positive for containing a suspected carcinogen and dangerous drugs.
The over-the-counter supplement contains sibutramine, the active ingredient in the now-defunct Abbott drug Meridia. Sibutramine can significantly raise blood pressure and pulse rate and might harm patients with a history of heart problems, the FDA said. Pai You Guo also contains phenolphthalein, an ingredient that was removed from over-the-counter laxatives after it was discovered to be a potential carcinogen.
Despite the 2009 recall, a recent study found that 23% of a group of 565 women reported using the supplement. Eighty-five percent of those who use Pai You Guo experienced side effects, including dry mouth, insomnia, and anxiety.
The FDA continues to work to get the word out about the recalled supplements. Surveillance programs are in effect to screen international shipments for traces of the sibutramine.
Posted on August 29, 2011 in Consumer Goods, FDA, Health & Medicine, Parenting, Recalls
- Vita Food Products is recalling more than 8,000 packages of Classics Premium Sliced Salmon Atlanta Nova Salmon due to listeria contamination.
- Fiskars Brands Inc. is recalling Fiskars® SmartPower™ String Trimmers sold from January 2011 to June 2011. Engine vibration during use of the trimmers can cause wear on the fuel line, leading to a propane fuel leak.
- Taylor Farms is recalling approximately 52,191pounds of chicken Caesar salad products because of misbranding and undeclared allergens.
- Triumph Motorcycles Ltd. says it is recalling certain bikes from the 2011 and 2012 model years to fix a potential problem with their engine-control electronics. If not repaired the problem could cause the motorcycles’ engines to stall unexpectedly while in traffic.
- Silva Sausage Co. is recalling about 28,782 pounds of chicken sausage products due to misbranding and an allergen in the product that isn’t listed on the label.
- 2-pound trays of Lowe’s Foods fresh ground beef are being recalled because pieces of blue plastic were found in the product. The products have establishment number “EST. 34176″ inside the USDA mark of inspection and a sell by date of 8/29/11 on the label.
- Radio Flyer’s Scoot ‘N Zoom children’s riding toys have been recalled due to a hazard of tipping over and allowing the child to fall forward.
- Ajinomoto Brand Vegetable Gyoza Dumplings are being recalled because the product may actually contain Seafood Dumplings made of fish and shrimp.
- Haircare Australia, a company that provides products to more than 5500 hairdressers across the country, has recalled 158 bottles of ”Brazilian Blowout” after the product was found to contain high levels of formaldehyde.
- Rojo’s Ultimate 7-Layer Dip and Fresh Food Concepts’ 5-Layer Dip are being recalled because they may be contaminated with listeria.
