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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New York Senator Charles Schumer has seen the effects of prescription drug addiction in his state and has vowed to fight it.  He warns that a new painkiller promising to be 10 times stronger than Vicodin could lead to more violent and deadly drug store robberies.

In June 2011, New York resident David Laffer was charged with robbing a Long Island drug store of more than 10,000 highly addictive prescription painkillers and killing four people in the pharmacy.  He and his wife had been doctor shopping before the robbery in an effort to get prescription pain pills like hydrocodone, which is highly addictive.

Nationwide, more than 1,800 pharmacies have been robbed in the past three years alone.  Long Island alone has experienced a 125 percent increase drug store robberies.

“It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the growing prescription drug crisis, new super-drugs could well be on their way, flooding the market.  The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics” Senator Schumer said.

The new painkillers, which contain pure hydrocodone, could come onto the market as early as 2013, with big pharmaceutical companies looking to cash in on the $10 billion prescription painkiller market.  At present, hydrocodone is classified as a strictly controlled Schedule II drug under the 1970 Controlled Substances Act. 

Products that contain hydrocodone and another painkiller like acetaminophen fall into Schedule III, which is less strictly controlled.  Some experts argue that because of this, highly addictive hydrocodone has been given to more patients, which has increased abuse of the drug and overdose rates in the United States.

A prescription painkiller that contains pure hydrocodone could lead to more accidental overdoses, leading to more emergency room visits.  Experts say that already thin hospital emergency room resources could become even more strained if this new drug is allowed on the market.  In 2008 alone, emergency room visits related to hydrocodone abuse totaled more than 86,000, up more than 400 percent from 2000 when an estimated 19,000 visits were recorded.

To learn more about prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com. 

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Far too many families have been devastated by a loved one’s addiction to prescription drugs. Unlike the images we conjure up when we think of a typical drug addict, the faces of prescription drug addiction are the faces of ordinary Americans. One of the casualties of prescription drug addiction was Christopher Scarborough, the 25 year-old son of Ken and Esther Scarborough of Kountze, Texas.

I came to know the Scarboroughs when I represented them in a legal case, which sought to hold the negligent parties accountable for Christopher’s death and to raise awareness about these pill mills, which often masquerade as pain management clinics. In the lawsuit, we alleged that the healthcare providers and clinic owners were nothing more than “drug dealers” who were trying to pass off their “pill mill” as a legitimate pain management clinic.

When Christopher went to this walk-in “pain management clinic,” he was prescribed a cocktail of more than 300 highly addictive narcotic pills, without even receiving an exam or seeing a doctor. Shortly thereafter, Christopher tragically died of an accidental overdose.

Rather than dwell on their son’s heartbreaking death, the Scarboroughs have chosen to help other families who have lost loved ones to prescription drug addiction and accidental overdose.

Since their son’s death, the Scarboroughs have worked every day to fight against the prescription drug epidemic in their son’s name. In 2009, they founded Parents Against Prescription Drug Abuse (PAPDA), a 501(c)(3) nonprofit corporation. They have also testified before the Texas Senate, worked to pass legislation to regulate the so-called pain clinics, given countless talks, and comforted other parents who have also lost their children to prescription drug overdoses.

The Scarboroughs need your help to continue their fight. You can help by making a tax deductible contribution to PAPDA at www.papda.net. Your contribution, no matter how slight, will help Ken and Esther keep fighting every day to prevent the reckless prescribing of narcotics from claiming another innocent life.

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Pharmaceutical company Purdue Pharma and three other companies have announced a new prescription drug that will contain pure hydrocodone, a highly addictive narcotic painkiller.  The pill is expected to be 10 times stronger than Vicodin, one of the strongest painkillers available on the market.

Hydrocodone is an opiate much like heroin, oxycodone, codeine, and morphine.  The United States is the largest consumer of hydrocodone prescription pills, using 99 percent of what is on the world market.  Much of the hydrocodone available today is combined with other painkillers like acetaminophen.

Over the years, these pain pills have been criticized for being too addictive.  For example, OxyContin, produced by Purdue Pharma, is the most abused pain pill in the United States. When OxyContin was first introduced onto the market in 1995, abusers quickly learned that they could get a stronger high from the time-release caplets by crushing them.

Today, prescriptions that contain hydrocodone are a quick second to oxycodone in terms of abuse.  A stronger painkiller that contains pure hydrocodone could be disastrous for a nation already suffering with substance abuse and addiction.

The market for pain pills is $10 billion, and pharmaceutical companies are coming up with new drugs to get into the lucrative market. But big pharmaceutical companies are marketing the new drugs as safer, arguing that fewer patients will experience liver problems like they do with drugs that contain acetaminophen.

A form of pure hydrocodone could be on the market as early as 2013, but with an even more addictive prescription on the market, more patients may become addicted to the drugs, leading to numerous overdoses that will strain hospitals resources.  Abuse of hydrocodone alone has led to an uptick in the number of emergency room visits related to hydrocodone abuse.  In 2000, more than 19,000 visits to the emergency room were related to hydrocodone abuse, but in 2008 that number grew more than four times to more than 86,000 visits.

Prescription drug addiction is a brain disease that can be fatal if undetected or untreated. To learn more about America’s prescription drug addiction epidemic, visit www.vanweylaw.com.

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(Image: Michelle Meiklejohn / FreeDigitalPhotos.net)

The Centers for Disease Control and Prevention (CDC) has issued a new report detailing that as many as 40 Americans die each day from overdosing on prescription painkillers.  That amounts to nearly 15,000 deaths each year.

Deaths due to prescription overdose are now more common than deaths caused by heroin and cocaine combined.  And the problem does not look like it will be ending anytime soon.  Prescription painkiller overdose deaths have increased three times over within the past decade.

80% of the World’s Painkillers are Taken in the U.S.

Director of the CDC, Dr. Thomas Frieden, blames irresponsible doctors for the uptick in prescription painkiller abuse.  He and other CDC experts have estimated that in 2010 enough painkillers were prescribed to supply every American adult with a one-month supply.

More than 600,000 doctors are licensed to prescribe opiate-based painkillers.  Vicodin is one of the most popular prescription painkillers, because it is not as strictly regulated as its counterparts, making it easier for doctors to prescribe.  In fact, 99 percent of the entire world’s supply of Vicodin is used by patients in the United States.

Accidental Overdoses from Prescription Painkillers Now Kill More People than Car Accidents in 17 States

The overprescribing of prescription painkillers is not only causing death, it is also costing an estimated $72.5 billion.  And, three of the hardest hit states are Oklahoma, New Mexico, and Florida.

The federal government has proposed expanding statewide prescription drug monitoring programs to monitor electronically the number of painkillers prescribed in each state.  But critics say these programs will not work alone.  Patients need to be educated about the dangers of abusing and overdosing on prescription painkillers.

National Drug Czar Gil Kerlikowske says doctors need to be retrained on writing prescriptions for narcotic pain relievers.  He adds that people with moderate pain, such as back pain, should not be prescribed these highly addictive painkillers.

To learn more about America’s epidemic of prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com.

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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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In a recent study out of the United Kingdom, researchers from St. George’s University, the University of London, and the University of Glasgow, found that high dose statin drugs increased the risk of patients contracting type-two diabetes.  But when the study compared Lipitor to Zocor and its generics, researchers found that Lipitor was more effective in decreasing the patient’s risk of a heart attack.

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With the new warnings released by the Food and Drug Administration (FDA) about Simvastatin, marketed under Zocor and Vytorin, some doctors are questioning the rates of occurrence of muscle damage in patients taking the 80mg dose.

• Take no more than 20mg of Simvastatin with amlodipine (market name Norvasc)
• Take no more than 20mg of Simvastatin with diltazem (market name Cardizem) or verapamil (market name Verelan)
• Take no more than 20mg of Simvastatin with amiodarone (market name Cordarone)
• Take no more than 20mg of Simvastatin with ranolazine (market name Ranexa)
• Never use Simvastatin with cyclosporine, danazol, gemfibrozil, or posaconazole.

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 Merck, the manufacturer of Zocor, drug name Simvastatin, announced it would be redesigning the label of its blockbuster drug.  The redesign comes on the heels of a seven year study that found that patients who took the higher dose of Zocor were at a higher risk of developing rhabdomyolysis, a disease that causes muscle fibers to break down and release myoglobin, a protein that damages the kidneys.

Symptoms of rhabdomyolysis include muscle cramps, muscle tenderness and stiffness, pain, and spasms.  The disease usually occurs in patients over the age of 65 or in those patients who have renal impairment or uncontrolled hypothyroidism.

Sales of the drug have been high in recent years, especially because the generic Simvastatin is available at a relatively low cost compared to some other statins currently on the market.  An estimated 1.2 million Americans are currently taking the 80 milligram dose of Simvastatin, the highest dose sold legally in the United States.

Despite its low cost, researchers urge that patients should talk with their doctors about switching to a newer generation statin, like Crestor, which has had a greater success rate with reducing cholesterol levels, without the harsh side effects.

Before muscle deterioration and damage became a worry to researchers, some worried that statins caused nerve damage.  

In 2002, Dr. David Gaist, MD, a researcher from Denmark, found that patients taking statins were at a nearly 16 times increased risk of developing neuropathy, compared to patients not taking statins.  And those taking statins for two or more years were at a 26 times higher risk for developing neuropathy.  Gaist concluded that the larger the dose given to the patient, the higher the risk that the patient would develop nerve damage.

Although the study conducted by the FDA did not reveal a link between Simvastatin and neuropathy, Dr. Gaist was on the right track with his research and the dangers posed by an increased dosage. Ultimately, Dr. Gaist’s report shows that the concern about the effects of Simvastatin on the human body was well-founded, even before the FDA saw fit to study the drug’s effects.

If you or a loved one has suffered from rhabdomyolysis while taking Simvastatin, call Van Wey Law today.

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