Pradaxa (dabigatran is a blood thinning medication that has been linked to adverse side effects since it was first approved by the Food and Drug Administration in October 2010. Reported adverse side effects include internal bleeding, heart attack, gastrointestinal bleeding, brain hemorrhaging, and in many cases death.
A recent report was published in the Journal for Neurosurgery on behalf of an 83 year old man who passed away after suffering a brain hemorrhage caused by Pradaxa. According to the report, he suffered a fall in his home and was prescribed Pradaxa to restore blood flow to his brain.
Within 6 hours after taking Pradaxa, the elderly man began to suffer from extensive brain hemorrhaging, according to a CT scan. Researchers and doctors believe that had there been the presence of a reversal agent in Pradaxa, the man’s life could have been saved.
The FDA approved Pradaxa for the treatment of atrial fibrillation in October of 2010. It is considered a new generation blood thinning medication and is often compared to competing drug Coumadin (warfarin , which is an older blood thinning medication. Pradaxa is included in a class of drugs referred to as direct thrombin inhibitors that prevent the enzyme which causes blood clot formation from functioning.
Atrial fibrillation is a dysfunction in heart rhythm often causing blood cells to form into blood clots. This condition may turn fatal if a blood clot reaches the brain leading to a stroke or to the lungs leading to a pulmonary embolism.
A recall has not been issued on Pradaxa despite the many adverse side effects reported to the FDA. Instead, the health regulating agency has undertaken investigating a large number of reported internal bleeding cases.
One of the first
Pradaxa lawsuits against Boehringer Ingelheim, the manufacturer of Pradaxa, was recently filed by a woman who claims Pradaxa caused the death of her mother after she suffered a gastrointestinal bleed.
“Don’t underestimate this simple activity,” says Jolene Matthews, who trains
The Real Housewives of New Jersey star
Jacqueline Laurita. She recommends skipping steps (i.e. two at a time on a staircase of about a dozen. Take ten trips to the top and you’ll burn about 200 calories (plus work your abs, butt, and legs all at the same time .
Matthews also recommends something you may have done without realizing its leg-shaping benefits–dancing! “There’s a reason why dancers all have amazing legs. It’s the perfect activity. It gets your heart rate up and firms the legs,” she adds.
Other exercises that offer leaner legs in just a few weeks?
Squats, lunges, jumping rope, and walking on an incline on the treadmill.
Electrolysis, the process of inserting a hair-thin needle device into the hair follicle that expels a small amount of electrical energy to eventually eliminate hair growth permanently, can be time consuming and costly. Depilatories, chemical-based hair removal creams, dissolve the hair but can irritate the skin and must be used regularly. And while waxing rips hair up at the root, it can be painful and you must have significant hair re-growth before you can wax it again (not a fan of showing stubble . Also; Beware of ingrown hairs with this method.
The most permanent option of the bunch is growing in popularity–laser hair removal. In fact, the American Society for Aesthetic Plastic Surgery estimates that in 2009 alone, more than 1.2 million laser hair removal procedures were performed in the U.S. Dr. Bank uses a type of laser called the LightSheer Diode Laser, which works by “targeting the hair follicle, below the skin’s surface.” The company that makes the laser says patients can see a 75-percent reduction in treatment time. With any laser, patients can expect to undergo at least three or four treatments at intervals of 4-8 weeks before their hair is permanently reduced.
There are also downsides to laser treatments such as pain, swelling and redness and, although rare,
blistering or permanent pigment changes can occur, especially if the patient has a tan. As for cost? Prices are based on the size of the area you’d like to treat and how many treatments you’ll need to undergo. Sessions can range anywhere from $500-600 and up.
When it comes to getting rid of stubborn, unwanted fat, there are a few new options.“The laser lipo body sculpting procedure, a procedure that uses a laser to ‘melt fat’ prior to performing liposuction, works particularly well at reducing unwanted fat on the inner and outer thighs and knee areas with minimal risks and a short recovery time,” plastic surgeon Dr. Neil Goodman says.
Similar procedures known as S.L.I.M Laser Liposuction and VelaShape, a combination of light and bi-polar radio frequency energies that, when combined with pressure, are also said to reduce the appearance of so-called “cottage cheese thighs.”
When it comes to bruises and scars, Dr. Bank recommends Fraxel laser, a treatment which can get rid of old scars. A drug called Tretinion, a combination of Retin-A and Renova, has also been shown to lessen the appearance of scars. For bruising, an array of creams or gels containing the herbs arnica Montana and Bromelain have been shown to make a difference.
When all else fails, simply use a heavy duty cover-up like
Dermablend that matches your skin coloring. Here’s a stylist’s secret: I’m a big fan of
Sally Hansen Airbrush Legs, which is actually a skin-colored leg makeup that comes in several shades and mimics the appearance of pantyhose. It can be found at any drugstore for just a few dollars. I use it for all my television appearances—it makes legs look perfect!
“It's not only your face that gets those unattractive brown spots, discolorations, and wrinkling from sun exposure,” says Allison Stallings, MD, a New York-based dermatologist. She notes that women’s legs are a common spot for skin cancer.
Both Dr. Stallings and Dr. Bank recommend this daily routine to improve over all skin tone and protect from sun damage: regular exfoliation (shaving does the trick , followed by a hydrating moisturizer with an SPF of at least 30. A good, regular pedicure with a mask never hurts either.
That being said, we still like our gams golden bronzed so the best thing to do is fake it! This can be achieved through sunless tanning. You can pick up an array of products at the drugstore or cosmetics counter, or you can go to a professional. Almost any tanning salon offers a spray tan via machine. You just step into the machine and within minutes are tanned to perfection. Or, you can do what the stars do and get an
“airbrush” tan done by a technician. This can cost a little more ($50-$80 , but the tech can better control the amount of the spray and the color.
fashionable ways you can enhance the gams you’ve got! The best news is you can cover up those legs until you’re ready to show them to the world with a great maxi! Stock up on an array of fun maxi skirts and dresses like Busy Philips, and you’ll be right on trend. Look for an all-over print and vertical seams for visual lengthening.
There are also a few stylists’ tricks I can share to make you look super-leggy. Nude shoes visually lengthen the leg line, and when they’re nude and high heels, your legs go on for miles. Another trick for creating the illusion of longer legs is by wearing pointy-toed shoes. Look for shoes with low-cut sides for extra elongation and, if you’re a little thicker in the ankles, avoid anything with an ankle strap that’ll stump the leg line or draw attention to that area. When you’re ready for that shorter skirt, make sure the hem hits just above the knee.
So go ahead, show some legs, ladies!
Whether it’s that your stems haven’t seen the sun in six months, you haven’t bothered to shave since Christmas, or your once-defined ankles have seemingly become one with your calves,
baring your bottom half can be bleak, to say the least.
reported earlier this week that it found the unsafe levels of the chemical 4-methylimidazole (4-MI -- used to make caramel color -- in cans of Coke, Pepsi, Dr. Pepper, and Whole Foods’ 365 Cola. Coca-Cola confirmed that changes were being made at its facilities to keep within the law but argued that the CSPI’s allegations on the dangers the ingredient posed on humans were false. “The company has made the decision to ask its caramel suppliers to make the necessary manufacturing process modification, to meet the specific Californian legislation,” A spokesperson for Coca-Cola told
Daily Mail Online. “Those modifications will not change our product.” California added 4-MI to its list of carcinogens, after studies showed high levels of the chemical led to tumors in lab animals. However, the studies were inconclusive on whether the chemical was dangerous to humans or not. “Caramel is a perfectly safe ingredient and this has been recognized by all European food safety authorities,” the spokesperson added. “The 4-MEI levels in our products pose no health or safety risks. Outside of California, no regulatory agency concerned with protecting the public’s health has stated that 4-MEI is a human carcinogen.” “The caramel color in all of our ingredients has been, is and always will be safe. That is a fact,” the spokesperson said. This had been the CSPI’s second go-around with the Food and Drug Administration (FDA over the dangers of 4-MI in soft drinks. It first petitioned the regulator last year, but the FDA has continually maintained that the claims were exaggerated. “It is important to understand that a consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents,” said FDA spokesman, Doug Karas to the Daily Mail's Laura Pullman. CSPI maintains that the regulator is allowing soft drink companies to needlessly expose millions of Americans to a chemical that is known to cause cancer. “If companies can make brown food coloring that is carcinogen-free, the industry should use it,” CSPI’s executive director Michael Jacobson told
Reuters. The FDA said it will review the watchdog’s petition, but that the soft drinks in question were still safe. CSPI took cans from stores in the Washington DC area, where they found some had levels of 4-MI near 140 micrograms per 12-ounce can. California has a legal limit of 29 micrograms of 4-MI per 12 ounces, it noted. The FDA’s limit for 4-MI in caramel coloring is 250 parts per million (ppm . Once the caramel is mixed in with the soda it becomes diluted. According to calculations by Reuters, the highest levels of 4-MI found in the soft drinks were about 0.4 ppm, significantly within the safe zone. “This is nothing more than CSPI scare tactics,” the American Beverage Association (ABA told Reuters in a statement. “In fact, findings of regulatory agencies worldwide ... consider caramel coloring safe for use in foods and beverages.” ABA said its member companies will continue to caramel coloring in certain products but that adjustments were being made to meet California requirements. “Consumers will notice no difference in our products and have no reason at all for any health concerns,” the ABA said. Diana Garza-Ciarlante, a representative for Coca-Cola, said its suppliers would modify the manufacturing process used to reduce the levels of 4-MI, which is formed during the cooking process and as a result may be found in trace amounts in many foods. “While we believe that there is no public health risk that justifies any such change, we did ask our caramel suppliers to take this step so that our products would not be subject to the requirement of a scientifically unfounded warning,” she said in an email to
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Four days later, Bandit collapsed on the floor.
He was soon experiencing bloody diarrhea, and by the time Higginbotham and her mother got him to his veterinarian, his organs were shutting down. His liver showed that he had eaten something toxic. Certain that Bandit's inexplicable illness had already become too severe, the veterinarian suggested putting him down, and Higginbotham's mother and son agreed.
But she refused, and after nearly $4,000 in medical bills and three weeks of intensive nursing that included in-home I.V. care, Bandit recovered. Though the vet could not link the chicken jerky to the illness, Higginbotham said he thought it was likely the cause.
Bandit's puppyish spark has come back, but Higginbotham remains anxious, feeling an overwhelming sense of helplessness over what she might be feeding her dog.
At the opposite corner of the country, in Eastern Florida, Danielle Kinard-Friedman's story did not end as well. Two weeks ago, Millie, her 18-month-old yellow Labrador, began vomiting bile after weeks of growing progressively more lethargic.
When Millie wouldn't eat anything, Kinard-Friedman took her to a vet. Blood tests revealed that Millie was experiencing kidney failure, and so she spent a week in an emergency pet clinic receiving intensive treatment that eventually proved futile. She was put down this past Sunday.
It was Millie's vet who asked Kinard-Friedman if she had been feeding her dog chicken jerky treats. She had. In fact, she had just started buying the treats -- under a different brand-name from Bandit's -- two months prior.
The vet then asked a more alarming question: Was the chicken from China? She had no idea, but she checked the label as soon as she got home. It was. When Higginbotham checked her treats, she found the same thing. Their vets could not prove anything, but both suspected the treats had sickened the dogs.
Higginbotham and Kinard-Friedman have now joined thousands of pet owners speaking out on the Internet and asking the government to force a recall of chicken jerky dog treats made from Chinese chicken. Concerns over the issue first arose as early as 2007, but the movement has gained significant momentum in the past month, even gaining the support of Ohio's Sen. Sherrod Brown and Rep. Dennis Kucinich after Ohio resident Candace Thaxton contacted them about two of her dogs who fell ill.
Congressmen and FDA sink their teeth in
On February 7, Brown
brought the issue to the Senate floor, saying he had urged the Food and Drug Administration to accelerate its investigation into these chicken jerky treats -- found under multiple brand names but all sourced from China -- that appeared to be sickening dogs across the country. Two weeks later, the senator held a press conference and issued a news release again urging the FDA to act swiftly.
Back on Nov. 18, 2011, the FDA cautioned consumers that chicken jerky dog treats from China may be associated with a rising number of dog illnesses. This followed earlier warnings of the same issue in September 2007 and December 2008. After a drop in 2009 and 2010, reports of dog illnesses have spiked once again. More pet owners are speaking out now than ever before.
The
November 2011 FDA notice warned dog owners who purchased chicken jerky to monitor their pets for decreased appetite, decreased activity, vomiting, diarrhea (including bloody , increased urination or increased water consumption. If any of those symptoms worsen or last more than 24 hours, owners should bring their dog to a vet, the notice said. Blood tests could indicate kidney failure, while urine tests might indicate Fanconi Syndrome, a disorder that results in nutrients normally absorbed into the bloodstream instead being released through urine.
What's more, an FDA spokesperson confirmed to Food Safety News that the agency has recently received more than 600 reports from dog owners who say their pets have fallen ill because of jerky products made from Chinese chicken.
Still, despite the increased scrutiny, the FDA has not revealed a contaminant in the jerky products. Without any clear cause of the illnesses, the agency can do little but continue to investigate the issue. In the meantime, the 15 companies with chicken jerky products implicated by consumers have issued no recalls, seeing no conclusive evidence that their products are harming animals.
Since the issue first arose in September 2007, the FDA has run numerous chemical and microbial tests on Chinese chicken jerky samples in search of a contaminant. Though the agency said it could not conclude anything from the test results, the details remained under wraps until March 1, when an FDA document describing tests dating back to 2007 was sent to Kucinich's office. According to a Kucinich aid, the congressman "took them to task" at a briefing in order to get the information.
The one-page document outlines 241 tests for potential contaminants and 130 tests with pending results, none of which conclusively link the jerky to contaminants at dangerous levels. The 2012 tests with results still pending, however, are searching for heavy metals.
The Kucinich aid and many pet owners said they hope those latest tests might finally link the treats to a toxic substance and resolve the mystery of their pets' problems. The FDA has stated repeatedly that it is actively investigating the issue.
According to the FDA, at least one Australian chicken jerky manufacturer has recently issued a recall of its products made from Chinese chicken, pulling the products as a precaution.
The agency may be mindful of March 2007, when hundreds of pet illnesses linked to melamine-contaminated Chinese ingredients prompted the recall of thousands of pet food products. The FDA received thousands of reports of dogs and cats dying from kidney failure, but confirmed very few cases.
Pet food industry says don't blame us
A month ago, the private Facebook group called "Animal Parents Against Pet Treats Made in China!" had roughly 100 members. Today, the number has exploded to more than 2,500.
One petition demanding the ban of jerky treats from China has acquired more than 3,000 signatures.
Susan Rhodes created
another petition on March 3. She has asked the FDA to recall the jerky treats after she found that her dog, Ginger, had suffered permanent kidney damage and was losing weight at an alarming rate. Rhodes said she had been feeding the treats to Ginger for the past two years. Days after creating the petition, she has racked up more than 300 signatures from dog owners reporting similar diagnoses.
Media coverage and word of mouth have brought a heightened level of attention to the manufacturers of these treats, some of whom report being hit with a large number of complaints. The amount of attention that seems to be snowballing, however, might lead some pet owners to incorrectly blame other health problems on the treats, said Kurt Gallagher, spokesperson for the Pet Food Institute, an industry public education and relations resource.
"Pet food companies want to make safe, nutritious products. It's their top priority," Gallagher told Food Safety News. "When everyone's talking about something like this, I think there's heightened awareness and sensitivity for pet owners looking for it."
Gallagher recommended pet owners take any sick pets to a vet to get a clinical opinion before diagnosing any issues themselves. If the vet considers pointing a finger at a certain food, the owners should contact the food manufacturer. Food companies should be tracking their complaints and looking for patterns and problems within their food supply, he said.
Pet owners have been quick to amass lists of jerky manufacturers sourcing their chicken from China. Rhodes' petition, for example, names 15 such companies.
A spokesperson for a dog treat company at the center of the furor reiterated that the FDA's testing has not found any contaminants and so his company has no reason to believe their product has sickened dogs. The company has a comprehensive food safety system at their Chinese facilities, he said, including quality control inspectors who monitor for safety. He added that his company appreciated hearing from concerned customers.
"Obviously, we take food safety very seriously," he said. "Millions of dogs enjoy our products without ever getting sick."
Multiple pet owners have told Food Safety News that the spokesperson's company has backed away from its original intention to offer customers small monetary settlements for harm their jerky might have caused pets. According to sources, once the complaints reached a certain volume, spokespeople for the company told customers that providing any settlements would be an admission of guilt.
Made in "America"?
Blogger Mollie Morrissette has been following the chicken jerky developments for more than a year on her website,
Poisoned Pets. She said that the issue has reached a sort of tipping point in the last month, with more and more pet owners speaking up about sick dogs.
"I get letters every day from broken-hearted pet parents -- people who had to put down their beloved family dog or five month-old puppy," she said. "They all fed their dogs chicken jerky."
One issue frustrating pet owners, Morrissette said, is that many of these dog treat packages boast that they are made in the U.S., though the fine print on the package often reveals that the chicken actually comes from China, where a cultural preference for dark meat makes for cheap white meat.
These "country of origin" claims are made possible by laws that say that once an ingredient is "substantially" altered in a given country -- the U.S., for example -- the resulting food can be considered a product of that country. These alterations can include cooking, mixing or otherwise reprocessing the ingredients in some way.
Just as oranges from Brazil can be turned into Canadian orange juice, chicken jerky from China can be reprocessed and repackaged in the U.S. to become a U.S. product. This can trick consumers into a false sense of security about the safety of their pet's food, Morrissette said.
Higginbotham said that the brand of jerky she bought for Bandit claimed to be "Proudly manufactured by an American company." Kinard-Friedman believed the same thing about the jerky she fed to Millie.
Morrissette said that pet owners feel helpless as they wait for some sort of justice on behalf of their pet, and she criticized the FDA for what she saw as a lack of urgency in investigating the illnesses.
"A lot of these pet parents are just wringing their hands, hoping the FDA will find some sort of answer," she said. "If this was [potentially contaminated] baby formula, we would have had the answer when it started five years ago. It would all get pulled off the shelves out of caution as soon as anyone suspected it might be contaminated." Owners say they won't back down
Candace Thaxton, the woman who spurred Senator Brown and Congressman Kucinich into action, has more than one dog motivating her to uncover that answer.
In November 2011, when her 10-year-old pug, Chansey, started urinating unusually often and refusing to eat, Thaxton assumed it was just a sign that the dog was simply getting old.
Chansey's health quickly deteriorated. At a vet appointment, Thaxton learned that the dog's kidneys had shut down and she would need intensive medical treatment to recover, if it was possible at all. Thinking Chansey had naturally progressed to the end of her life, the Thaxtons chose to have her put down.
Within weeks, the family had adopted a mixed-breed "pixie" puppy named Penny, who earned a pristine bill of health at her first vet appointment. Right around Christmas Day, Thaxton ran out of the treats that came with Penny when she was adopted, so she started feeding her Chansey's leftover treats: chicken jerky. Of course, Chansey had never eaten jerky until weeks before she grew sick. She had never even finished her first bag.
In the weeks that followed, Penny started urinating a lot more than normal. Then, after New Year's Day, Thaxton saw a news story online about the FDA's warning for chicken jerky made from China. She checked her bag of treats, which said it was from South Carolina.
Then she noticed the text over the barcode: "Made In China."
Thaxton stopped feeding her the treats, but Penny started vomiting. When the vet saw her, she showed all the same symptoms as Chansey.
"Her kidneys were worse than Chansey's," Thaxton said.
Penny went on 24-hour surveillance at an emergency pet clinic. She recovered a week later, but Thaxton was just getting started.
"Candace went to bat," Morrissette said. "She's the driving force behind all of this, all the publicity."
Thaxton filed two complaints with the treat manufacturer -- one for Chansey, one for Penny. It looked like she was going to at least get a settlement amount to cover part of her $3,000 vet bill, but the company eventually rescinded as more complaints began to pour in, Thaxton said.
Even before the settlement talks broke down, Thaxton's story had run on two local news channels. When the company refused to pay her, Thaxton promised to take the issue national within the week.
"By Friday night, Congressman Kucinich had written a letter to the FDA. By Monday, I had a press conference with Senator Brown," she said. "We've had two more conferences since then. I talked to Inside Edition. I told them I was going to be the one who pushed. I'm not stopping now."
Like Thaxton, other pet owners seem determined to keep the pressure on FDA to find answers and hold any guilty party responsible. For many, a sense of uncertainty, frustration, and even guilt, lingers.
"Pets are part of your family. When they die, you lose a family member," Higginbotham said. "I'm dealing with a lot of guilt over this. I'm the one who feeds my dog and is supposed to make sure he's safe and healthy. How do I do that if I can't even trust his food?"
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Photo captions, from top to bottom:
- Bandit, Maria Higginbotham's dog
- Ginger, Susan Rhodes' dog
- Sarge, Ray Parker's dog. Sarge, a seven year-old chow-corgi mix, fell ill soon after eating a single chicken jerky dog treat, Parker said. After nearly two weeks of clinical treatment, including intensive critical care, Sarge was put down.
- Chansey, Candace Thaxton's dog
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