Pill Mill Monitor : Personal Injury Lawyer & Attorney : Kay Van Wey Law Firm : Prescription Drug Overdoses & Pharmaceutical Abuse

Paula Deen recently endorsed the potentially dangerous diabetes drug Victoza, making headlines that have drawn criticism.

On Victoza's label is a warning that the drug may cause pancreatitis, much like the warnings on other diabetes drugs Byetta and Januvia. Since the drug was approved in 2010, health experts have become increasingly concerned that this drug also increases the risk of pancreatitis. 

But Paula Deen is not the only celebrity who has promoted or is currently promoting a potentially dangerous drug. Other celebrities include Paul and Mira Sorvino who have promoted diabetes drug Lantus, which studies have found may double the user’s risk of getting cancer.

And diabetes drugs are not the only pharmaceutical drugs with dangerous side effects. Within the past couple of years, studies have shown that bisphosphonates, like Boniva and Fosamax, cause low impact femur fractures. Many of the patients taking these drugs who suffered femur fractures were doing simple activities at the time of the fracture, including stepping off a curb. Actress Sally Field has appeared on commercials for Boniva since 2006. 

In addition, pro-golfer Phil Mickelson suffers from psoriatic arthritis, an autoimmune disease. He is currently endorsing Enbrel, a drug that blocks proteins, which can cause arthritic inflammation. Enbrel and other drugs like it suppress the immune system, putting patients at risk for contracting dangerous infections, including tuberculosis and histoplasmosis. Numerous deaths have been linked to these infections.

Finally, former Olympic champion Bruce Jenner promoted the top-selling arthritis drug Vioxx. But in 2004, Vioxx was recalled after studies found it increased the risk of heart attack. Jenner claimed that he had never been told about the risks.

Unfortunately, some drug companies care more about profits than about the health of patients. To learn more about the secrets of the pharmaceutical industry and deadly side effects, download my e-book, 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know.

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Since November 2011, at least 260 deaths worldwide have been linked to new blood thinner Pradaxa.  An estimated 1.1 million prescriptions have already been written for Pradaxa, and 371,000 patients are currently taking the drug.

Serious Bleeding Events

Pradaxa was approved by the Food & Drug Administration (FDA) in October 2010 to reduce the risk of blood clots and strokes in patients with non-valvular atrial fibrillation.  Just over a year after being approved, the FDA issued a safety communication for Pradaxa, warning consumers that patients taking the drug have reported experiencing serious bleeding events.

Symptoms of these adverse events include the following:

• Persistent nose bleeding
• Unusual gum bleeding
• Vomiting or coughing up blood
• Bruising
• Heavier than normal menstrual bleeding
• Red or black stool
• Pink or brown urine
• Severe or uncontrollable bleeding

The FDA recommends that if you or a loved one experiences any of these symptoms, you seek the help of a health care provider immediately.

Can We Trust the FDA?

Although the FDA is currently investigating claims that Pradaxa has caused serious bleeding, the agency maintains that "[a]t this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”

The FDA has made statements like this before for drugs that were later proven to indeed be very dangerous.  Patients taking Avandia, for example, reported adverse events like heart attacks.  The FDA had approved Avandia in 1999 simply because it helped diabetics to control blood sugar levels.  But after nearly 47,000 people taking Avandia suffered a heart attack, stroke, or even death, the FDA finally restricted the use of the drug in 2010.

More recently, the FDA has received criticism for allowing experts with conflicts of interest to sit on a panel to determine whether the popular birth control pills Yaz and Yasmin should be taken off the market.  At least four of the experts on the panel had received compensation from Yaz and Yasmin’s manufacturer Bayer.  All of them voted in favor of keeping the pills on the market.

And it seems as though the FDA may be behind the curve on Pradaxa. Both Japan and Australia have issued safety warnings, linking Pradaxa to serous bleeding events.

To learn more about the pharmaceutical industry and why the FDA approves these dangerous drugs, download my FREE e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com today.

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Southern chef Paula Deen recently announced that she has type-2 diabetes, which did not surprise many Americans, who for years have watched the chef make dishes loaded with calories, fat, and sugar.  With her health announcement, Deen also announced that she was endorsing diabetes drug Victoza, made by drug company Novo Nordisk.

Big Pharma Influences How People View Diabetes

Deen’s partnership with big pharma drew criticism not only from her critics, but also from her fans.  Chef Anthony Bourdain has criticized Deen’s cooking for years, and upon learning of her announcement, took to Twitter writing “Thinking of getting into the leg-breaking business, so I can profitably sell crutches later.”

While Deen has said she has changed her eating habits and has cut out the sweet tea, many question whether she really has changed the way she eats or whether she’s simply using Victoza to counteract eating poorly.  Either way, her recent partnership sends the message that people can eat what they want, and if they happen to develop diabetes, there’s a drug for that.

Diet & Exercise May Reverse Type-2 Diabetes

Health experts say people with type-2 diabetes don’t necessarily need to take diabetes drugs, many of which have been found to cause bladder cancer, thyroid cancer, and pancreatitis.  For many patients, eating better and exercising can reverse a type-2 diabetes diagnosis. Pastry chef Michael Mignano is proof of this.

Mignano spent years sampling his own sugar-filled creations and picking up fast food after a long day at work.  By the time he turned 36 years-old, he weighed 500 pounds and had been diagnosed with type-2 diabetes.  Realizing the risks he was taking by eating unhealthy, Mignano agreed to go on “Fat Chef,” a new show on Food Network in which chefs like Mignano learn how to eat healthy and exercise.

Since filming, Mignano has lost over 100 pounds and has reversed his type-2 diabetes diagnosis, all without taking pills.  “Medicine is great, but it gives you this false sense of healing, but it’s not really doing what it’s supposed to do,” he said in a recent interview with ABC News.

Mignano is the first to admit that working with the food that contributed to his obesity is not easy, and neither is getting into a regular exercise routine.  But he says “It just makes me a happier chef, a happier person, which the result, you have happier food.”

Although “Fat Chef” is done filming, Mignano says he plans to stick with his diet and exercise regimen.  He hopes to drop his weight down to 250 and stay diabetes free.

Big Pharma’s Influence

For years, major pharmaceutical companies have pushed diabetes drugs on Americans with ever-growing waistlines, sending the message that you can eat whatever bad food you want because a pill will nullify the food’s bad effects.  But drugs like Avandia, Actos, and even Paula Deen’s Victoza may be more dangerous than helpful.  Avandia was pulled from the U.S. market completely after studies showed it caused heart attacks and death.  Actos is still on the market, but has been shown to cause bladder cancer.  And Victoza may cause thyroid cancer and acute pancreatitis.

To learn more about how big pharma influences consumers and their doctors, download my free e-book Prescription Drug Safety today at www.vanweylaw.com.

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 “...when ya’all sit down to a simple plate of crisp fried chicken; a fluffy, warm, just-buttered biscuit; a mess of greens cooked down with a bit of ham; and a tall, handsome banana cream pie topped with ice-cold whipped cream afterward, well, you’ll have to agree; there is just nothing better.” Paula Deen, Southern Cooking Bible

Don’t get me wrong, I like Paula Deen. Her down home genuineness is familiar to me, although, I have wondered on occasion if that southern drawl is drawn out just a little more for the cameras.

At my roots, I am a southern lady. I am a baby boomer who grew up in a small town in southwestern Oklahoma.  I am a foodie, and I hail from a family that loves to eat.  Even before Paula Deen became a household name, my mother used to say that she’d slip in an extra stick of butter into her cheese grits recipe when Dad wasn’t looking.  Of course, back then we didn’t really completely understand the health dangers of some of the foods we were eating.

Just a few weeks ago, we enjoyed the holidays with some of Paula’s best recipes, including gooey pumpkin bars for Thanksgiving, chocolate pecan pie for Christmas, and brisket and cheese grits for New Year’s Day.

But the recipes that live on in our family traditions precede the advent of direct-to-consumer advertising by pharmaceutical companies.  The Gen X and Gen Y kids have grown up being fed a steady diet of pharmaceutical company ads, sending the message that drugs are good and that a little pill will cure us of our ailments.  We are being trained by these pharmaceutical companies and their Madison Avenue advertising agencies to eat whatever we want, including that high fat cheeseburger; after all, we have a pill to lower high cholesterol.  And if you develop diabetes, it isn’t a death sentence. We have pills for that. Want to perform better in bed? We have pills for that. Want longer eyelashes? You guessed it…we’ve got a pharmaceutical solution.

Now, as I have said before, there are many good drugs on the market that actually cure disease. There are many drugs on the market that some people can’t live without.  But, major pharmaceutical companies are also coming up with a whole new generation of drugs that are more like lifestyle drugs. They don’t cure anything, and they allow people to make really poor choices, thinking that a pill will make up for their bad decisions.

I wish a fraction of the money that was spent peddling drugs for chronic illnesses such as diabetes, high blood pressure, high cholesterol, and the like was spent on educating people about how to prevent themselves from getting these conditions in the first place.

What many people don’t know is the high risk and sometimes deadly toll some of these drugs can have on people. For example, the diabetes drug Avandia caused an estimated 83,000 heart attacks between 1999 and 2007, some of which resulted in death. The FDA finally pulled the drug from the market after trial lawyers had filed thousands of lawsuits against Avandia’s maker.

Another popular diabetes drug, Actos, has been pulled from the market in France and Germany after studies show it dramatically increases the risk of bladder cancer.  But Actos remains on the market in the United States, putting patients in danger of developing the disease.

I won’t stop buying Paula Deen cookbooks, and I will still make some of her recipes on special occasions. But listen up y’all, I can’t help but wonder why she waited three years to make the announcement that she has type-2 diabetes. Three years Paula? Come on now. Did it take your lawyers and agents that long to strike a 7 figure deal with a pharmaceutical company to endorse its diabetes drug? Was the timing of your announcement pure coincidence when it coincided with the announcement of your endorsement deal with Novo Nordisk?

While I am truly sorry to hear about Paula’s diagnosis, I can’t help but be disappointed in the fact that she has teamed up with a pharmaceutical company to market drugs for people to rely upon, instead of focusing on helping people lead healthier lives.  To learn more about how pharmaceutical companies get you to buy their drugs, download my free e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know today at www.vanweylaw.com.

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Looks like the Food & Drug Administration (FDA) will face pressure to take another vote on the popular birth control pills Yaz and Yasmin as reports surface that at least four of the experts had ties with manufacturer Bayer.

FDA experts met on December 8, 2011, to determine whether Yaz and Yasmin are safe for women to take.  The panel voted 15 to 11 to keep the pills on the market, citing that the benefits of the pills outweighed the risk of blood clots. 

Experts Received Money from Bayer

Dr. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, was one of the experts who served on the Yaz panel and had ties with Bayer.  Before 2009, Dr. Johnson was paid by Bayer for work she did for the company. 

Additionally, she conducted clinical trials for Berlex, a pharmaceutical company acquired by Bayer, studying the effects of Drospirenone.  Drospirenone is the synthetic hormone found in Yaz and Yasmin that health experts believe may be contributing to the increased risk of blood clots in women taking the drugs.  That clinical trial involved a hormone replacement therapy, not birth control, and Dr. Johnson has denied any bias for Bayer or its products.

Another expert on the panel who received funding from Bayer was Dr. Anne Burke.  On a Bayer internal document, Dr. Burke is listed as a Bayer contraception expert.  She received research funding from Bayer, but stated that this occurred several years ago.

Two other experts admitted to having either past financial ties or research ties with Bayer.

All four of the experts voted in favor of Yaz and Yasmin, noting that they believe the risk of blood clots associated with the birth control pills is outweighed by the benefits of the drugs.

One expert who was not allowed on the panel because of an “intellectual conflict of interest” was Dr. Sidney Wolfe of consumer advocacy group Public Citizen.  Because he has criticized Yaz as being an unsafe drug in the past, the FDA determined that Dr. Wolfe was too biased to serve on the panel.

This recent development raises the question: To whom is the FDA really catering--consumers or big pharmaceutical companies?  Based on the background of the Yaz  panel, it would seem that consumers are taking a backseat to pharmaceutical companies with money to hand out.

To learn more about how big pharma influences the FDA, download my free e-book Prescription Drug Safety at www.vanweylaw.com.

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Recent studies have shown that women using Yaz and Yasmin birth control pills have a higher risk of experiencing a blood clot while on the pills, but new findings show Bayer knew about the risk as early as 2004.

Former FDA commissioner David Kessler testified in an Illinois federal court that Bayer omitted from its safety analysis of Yaz/Yasmin reports of an increased risk of venous thromboembolism, which can lead to a potentially deadly pulmonary embolism.

By omitting this data, Kessler testified that “Bayer presented a selective view of the data, and that the presentation obscured the potential risks associated with Yasmin.”

Venous Thromboembolisms

One of the most significant risks associated with Yaz/Yasmin is that of a venous thromboembolism, or a blood clot.  Blood clots can be deadly if they lead to deep venous thrombosis (DVT) or a pulmonary embolism.

DVT mainly occurs in the lower extremities, but can occur in the upper extremities as well. Symptoms of DVT include swelling, pain, tenderness, and skin that is warm to the touch.

Pulmonary embolisms occur after a blood clot has been released into the bloodstream.  If the blot gets stuck in the heart, brain, or other major organs, severe damage or even death may occur.

Yaz & Yasmin Lawsuits

More than 10,000 lawsuits have been filed against Bayer, alleging women taking the pills suffered injuries.  At least 50 women died from taking Yaz and Yasmin between 2004 and 2008.

Yaz and Yasmin are two of the top oral contraceptives on the U.S. market, generating $1.58 billion in sales last year alone.

If you or a loved one has experienced a blood clot, DVT, or pulmonary embolism while taking Yaz, Yasmin, or another birth control containing the synthetic hormone Drospirenone, experienced dangerous drug attorney Kay Van Wey may be able to help you. Call Van Wey Law today at (800) 498-5082 for more information.

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The popular birth control pills Yaz and Yasmin are currently being reviewed by the Food and Drug Administration (FDA) for their propensity to increase a woman's risk of having a heart attack or stroke. But more recently, concerns that the pills may also cause pancreatitis have arisen.

Pancreatitis affects the pancreas, which regulates glucose in the body, and occurs when the pancreas becomes inflamed and can no longer control glucose levels.  If untreated, pancreatitis can cause severe bleeding and permanent damage.  Pancreatitis can cause total organ failure of the heart, lungs, and kidneys, which can lead to death.

The FDA has issued a new warning that Yaz and Yasmin can cause pancreatitis in women who have high cholesterol or who have a family history of developing hypertriglyceridemia, which affects fat cells.

Women taking these birth control pills should watch for symptoms of pancreatitis, which include:

• Pain and swelling of the upper abdomen
• Nausea
• Vomiting
• Fever
• Rapid heart beat
• Sudden weigh loss
• Diarrhea
• Pain when eating or drinking

If you or a loved one has suffered from pancreatitis while taking Yaz or Yasmin, contact Texas dangerous drug attorney Kay L. Van Wey at 800-489-5082 to learn more about your legal rights.

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(Image: dan / FreeDigitalPhotos.net)

Last week, the Food & Drug Administration (FDA) released the findings of two federally-funded studies and found that anti-smoking drug Chantix did not increase psychiatric problems in patients taking the drug.

The studies relied upon by the FDA followed more than 26,000 patients taking Chantix.

Volatile History

Chantix, which is manufactured by major pharmaceutical company Pfizer, was first approved for use in 2006. Beginning in 2007, experts began raising safety concerns about Chantix, citing cases of cardiovascular problems and changes in vision.

As more people began to take Chantix, more reports of depression and suicidal thoughts were reported by patients taking the drug.  This prompted the FDA to place a black box warning label on Chantix in 2009 to caution doctors and patients about the drug’s risk of causing depression, suicidal thoughts, and hostility.

FDA’s Studies Miss the Mark

The two studies cited by the FDA did not produce definitive findings.  The studies, conducted by the Department of Veterans Affairs and the Department of Defense, were not large enough to determine rare side effects.  Additionally, the studies reported psychiatric problems that led to hospitalizations only, which completely disregarded any unreported issues.

New Study Urges FDA to Update Chantix Warning Label

A study published in PLoS One Journal found that Chantix makes psychological symptoms far worse than any other nicotine replacement drug.  Although this study was much smaller than the federally-funded studies, it focused specifically on adverse event reports of depression and suicidal behaviors in people taking Chantix, its competitor Zyban, or other nicotine replacement drugs.  The adverse events were reported through the FDA’s Adverse Event Reporting System (AERS).

The findings of the study are alarming. A staggering 90 percent of the 3,000 reports of suicidal thoughts and depression were linked back to Chantix.  Of those completed suicides, 92 percent were linked to Chantix.

Despite these findings, the FDA continues to report that Chantix is a safe and effective way for smokers to kick the habit.  Pfizer released a statement regarding this most recent study, saying “often these reports lack sufficient medical information to enable meaningful assessment.”

Know Your Risk

Nearly 22 million prescriptions have been written for Chantix since it was first approved in 2006. Since then, commercial pilots have been banned and truck drivers have been restricted from taking the drug, due to black-outs and vision problems.

The Veterans Administration recommends its patients undergo a mental health evaluation before being prescribed Chantix.  Experts behind the most recent study agree, saying that the risks associated with Chantix outweigh the benefits.

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Within the past year, popular birth control pills Yaz and Yasmin have come under fire from medical professionals and the Food and Drug Administration (FDA) for safety concerns.  The FDA has now released a new study, which suggests the pills pose an even greater risk of blood clots than previously thought.

Yaz and Yasmin are considered fourth generation birth control pills because of a synthetic hormone they contain called drospirenone, which is similar to the natural female hormone progesterone and increases potassium levels in the blood.  The pills have been touted by manufacturer Bayer as designer drugs that eliminate premenstrual symptoms (PMS). Of course, Bayer was forced to pull the advertisements claiming this back in 2009.

Based on recent studies about these birth control pills, medical experts believe drospirenone could be the culprit of increased blood clots seen in women taking these pills.  The most recent studies evaluated data from more than 800,000 women ages 10 to 55 who took the pill over a period of six years.  The results of the studies were alarming--women taking Yaz were 75 percent more likely to experience a blood clot than women taking birth control pills that do not contain drospirenone.

Despite the safety concerns with these pills, Yaz, Yasmin, and other drospirenone-containing birth control pills accounted for $1.6 billion in world-wide sales last year alone.

The FDA also analyzed data from studies conducted on the Ortho Evra patch and the Nuvaring vaginal ring.  Results from those studies found that women using those forms of birth control experienced more complications than women using traditional or third generation birth control pills.

Although none of these products have been pulled off the market, the FDA will be meeting December 8^th to determine the safety of these drugs.  For now, consumer safety advocates are calling on the FDA to stop approving newer, less safe drugs when cheaper, safer generics are widely available on the market.

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(Image: m_bartosch / FreeDigitalPhotos.net)

The Food and Drug Administration (FDA) has issued an update to the drug label for Reclast, an injection used to prevent or treat osteoporosis.  The new warning is in regards to the risk of renal failure.

Reclast, generic name zoledronic acid, is a bisphosphonate that is used to treat or prevent osteoporosis in women who are in menopause and to increase bone mass in men with osteoporosis.  The injection is given in a single dose every one to two years.

The FDA has recently received reports of patients experiencing kidney failure while taking Reclast.  These patients reporting kidney failure either required dialysis or died from the complication.

While kidney failure is a rare condition in patients using Reclast, it is more likely to occur in those patients who have a history of or risk factors for kidney problems.  Risk factors include an underlying moderate to severe renal impairment, use of kidney-damaging or diuretic medicines, and severe dehydration before or after receiving Reclast.

The risk of developing renal failure increases with age.  Your doctor should screen you for any kidney problems prior to giving you Reclast.  You should tell your doctor about any medications you are taking so that he or she can better identify whether these medications will adversely react with Reclast.

Earlier this year, Reclast was identified as a drug that is likely to cause a femur fracture in patients.  The FDA has sent out a safety announcement warning patients about the risks bisphosphonates pose and is continuing to review data regarding the risk of femur fractures in patients.

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Prescription drug prices in the United States are through the roof.  In 2005, we spent an estimated $251.8 billion on prescription drugs alone.  This year, prescription drug sales are expected to reach $310 billion.

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On August 16, 2011, the United States Judicial Panel on Multidistrict Litigation “MDL Panel” created a new multidistrict litigation (“MDL”) for Darvocet, Darvon, and Propoxyphene products liability cases, finding that centralization of these cases is appropriate under 28 U.S.C. § 1407.  The MDL Panel decided to centralize the cases in the Eastern District of Kentucky (Covington Division).  With the consent of that court, the cases will be assigned to Judge Danny C. Reeves.  Accordingly, the MDL Panel ordered transfer of the seventeen actions before it for consideration to the Eastern District of Kentucky (Covington Division).

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This past Wednesday, the Food and Drug Administration (FDA) released a revision of the prescribing information for the drug simvastatin, market name Zocor, which is prescribed to patients with high cholesterol.  

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