FDA Panel Considers Tightening Rules on Hydrocodone Prescriptions

 According to recent statistics, the United States consumes 99 percent of all Hydrocodone in the world, yet the United States is merely 4.5 percent of the world’s population.  In 2010, an estimated 131.2 million prescriptions were written for Hydrocodone, making it the most prescribed drug in the United States.  Hydrocodone is a highly addictive painkiller and has been blamed on overdoses and deaths.

Prescription Painkiller Addiction is an Epidemic in the United States
Abuse of prescription painkillers in the United States is an epidemic.  Reports of pharmacies being robbed for Hydrocodone and other strong narcotic painkillers are all too commonplace.  Now the Drug Enforcement Administration (DEA) is asking for help from the Food & Drug Administration (FDA) to tighten regulations and make it more difficult to get prescription drugs containing Hydrocodone.  
 
“If Hydrocodone has more restrictive manners tied to it, it could help reduce the abuse potential,” says Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section.
 
FDA Advisory Panel Could Mandate Tighter Restrictions on Hydrocodone
In response, the FDA convened an advisory panel for a two-day meeting on Thursday, January 24, 2013.  The panel is to consider tighter regulations for the prescribing of drugs and other products that contain Hydrocodone.  One of the proposed regulations would limit prescriptions of pills and cough syrups containing Hydrocodone to a 90-day supply.  Currently, these products are available to be filled with five refills within six months.  The advisory panel will also consider moving Hydrocodone-combination products like Vicodin up from a Schedule III to a Schedule II drug, which is more highly regulated.  Drugs currently in Schedule II include OxyContin and pure Hydrocodone.
 
Advocates of tighter restrictions on Hydrocodone believe that moving Hydrocodone-combination drugs to a Schedule II classification will make the drugs less available.  A similar measure was attempted in 2012 with a proposed amendment to the Prescription Drug User Fee Act (PDUFA), but lobbyists for pharmaceutical companies fought against the amendment, and ultimately it was defeated.
 
Big Pharma Looks to Cash-in on Hydrocodone with New Drugs
Another FDA panel recently voted against approving Zohydro, an extended-release drug that contains pure Hydrocodone.  Manufactured by Zogenix Inc., the new painkiller is ten times more powerful than Vicodin and highly addictive.  Although the FDA panel found that the new drug met FDA standards for safety and efficacy, it voted against approval of the drug based on its high potential for addiction.  The FDA will consider the panel’s findings, but may still approve Zohydro in March when it comes up for consideration.
 
For more information about Hydrocodone and prescription drug addiction, read:

Babies Born addicted to Pain Killers

Kate Snow reports 

 

A great news piece aired on July 5, 2012 concerning the alarming rate of babies who are born addicted to pain killers. Please watch this to understand one of the tragic consequences of the prescription drug epidemic we have in the U.S. The effects are far reaching. The long term consequences on these children is not yet known. 

I welcome your comments and opinions on what can be done to reverse this terrible epidemic which has such far reaching consequences for our citizens and our country.

Big Pharma's Marketing of Painkillers Launches Senate Probe

Accidental overdosing on prescription drugs now kills more people in some states than car accidents.  Now, the U.S. Senate Finance Committee is investigating the marketing practices of pharmaceutical companies that make highly addictive narcotic painkillers.

The Senate Finance Committee launched the investigation to help ensure consumers are not being misled into thinking that these opioid painkillers are completely safe. 

“Overdoses on narcotic painkillers have become epidemic, and it’s becoming clear that patients aren’t getting a full and clear picture of the risks posed by their medications,” said Senator Max Baucus, who along with Senator Charles E. Grassley has launched the investigation.

Non-Profits Promote Pain Drugs

Pain advocacy organizations have popped up in the past decade, including groups like the American Pain Foundation, which received nearly 90 percent of its funding in 2010 from the pharmaceutical and medical device industries.  These groups highlight the benefits of opioid painkillers and downplay the risks, which include addiction.

The American Pain Foundation has decided to dissolve amid the allegations that it has illegally marketed painkillers. However, the group has cited the decision to dissolve based on operational and financial problems.

The Senate investigation comes just months after Purdue Pharma (maker of the highly addictive Oxycontin) announced plans to release a painkiller 10 times stronger than Vicodin.  The painkiller contains pure hydrocodone, which doctors believe will lead to more accidental overdoses.

Three pharmaceutical companies are being investigated in the Senate probe, including Purdue Pharma, Endo Pharmaceuticals, and Johnson & Johnson.  Five different pain support groups are also being investigated, including the American Pain Foundation, the American Academy of Pain Medicine, the American Pain Society, the Wisconsin Pain & Policy Studies Group, and the Center for Practical Bioethics.

Even the Joint Commission, a nonprofit hospital accreditation group, is being investigated for its partnership with Purdue Pharma.  The group not only brought pain management to hospitals’ attention as a national priority in 2001, but also distributed to those hospitals pain education materials promoting Oxycontin.  The group already pled guilty in 2007 to criminal charges that it understated the risk of addiction with Oxycontin.

Experts Voice Concern about Painkiller Addiction

Narcotic painkillers are currently the most widely prescribed drugs in the United States, despite their classification as highly addictive substances akin to illegal drugs.

Sales of painkillers have risen nearly 300 percent since 1999, and in proportion, the number of deaths due to painkiller overdoses has also risen.  Prescription painkillers are now available even to high school students who have held “pill parties” in which they bring different medications they find around their homes, including painkillers, and take pills without knowing what those pills are.

Even newborns are being born addicted to painkillers.  The Journal of the American Medical Association recently released a report finding that newborns are being born with drug withdrawal at a rate five times that of levels in 2000.

Pain awareness groups have “helped usher in an epidemic that’s killed 100,000 people by promoting aggressive use of opioids.  What makes this especially disturbing is that despite overwhelming evidence that their effort created a public health crisis, they’re continuing to minimize the risk of addiction,” said Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in New York.

Since the 1990s, big pharma has marketed these painkillers to more groups of people.  Before, the pills were largely used to help cancer patients, but companies like Purdue Pharma have sold doctors and consumers on broader uses for the pills, including arthritis and back pain.  Senators Baucus and Grassley noted “There is growing evidence pharmaceutical companies that manufacture and market opioids may be responsible, at least in part, for this evidence by promoting misleading information.”

While these painkillers do have their uses in some patients, the overprescribing of these pills is clearly out of control.  Oftentimes, doctors prescribe the pills without fully explaining to the patient the risk of addiction and overdose.  Critics have said that many doctors need to be retrained on when it's appropriate to prescribe narcotic painkillers.

I will continue to post updates about this and other pill mill news.  For the latest information on prescription painkillers and pill mills, subscribe to my blog.

Raid on Dallas Pill Mill yields more details

Dr. Lee Roy McCurley

 

The name of the physician who allegedly owned and operated the South Dallas Pill Mill has been released. According to the Texas Medical Board,  Leeroy McCurley, M.D. is a family practice physician. Dr. McCurley appears to have no specialty training whatsoever in pain management. Dr. McCurley is not board certified in family practice or any other medical specialty, which according to many doctors is the "gold standard" for physician competence. 

In my experience, it is not uncommon to see family practice doctors self-declare themselves as pain management specialists. And, to my knowledge, there is no requirement that a doctor receive any type of special training in pain management in order to prescribe any quantity or combination of potentially lethal narcotics.

However, let's be mindful of the fact that based upon what we know thus far, it wouldn't appear that there was any medicine being practiced at this clinic. By all accounts it appears to be a storefront drug dealing operation, which operated for well over a year in plain sight.

I have often questioned the motives of physicians who like Dr. McCurley become involved in a criminal operation like what has been alleged in this case. We really don't have to look much further than what was reported in the newspaper as $2 million dollars per year in cash.

Even though we do see the occasional raid like this one, there still remains the potential for enormous cash profits with very low probability of arrest and prosecution. Therefore, as long as white coat drug dealing is profitable the pill mills will flourish.. People will continue to die and the prescription drug epidemic we have in this country will continue to claim lives.

Dallas Pill Mill Raided

 

On May 1, 2012,  local and federal officials descended upon a Dallas medical clinic suspected of operating as a pill mill.

Details are lacking at this time about the identity of the doctor accused of operating a Dallas Pill Mill. However, it has been reported that this doctor has previously been sued and may have also operated a similar practice in Grand Prairie, Texas.

I am anxiously awaiting the news of this clinic and doctor and will hopefully have more to report soon. It is good to see Law enforcement acting on clinics like these that seem to operate their questionable practices in broad daylight. 

To read more about how to spot a pill mill, click here to read an article I previously wrote on the subject.

Dangerous Drug Spotlight: Pradaxa Can Cause Fatal Bleeding

When we are given a prescription for a serious condition by our doctors, we assume that the doctor knows best and would not prescribe a dangerous medication. Unfortunately, dangerous medications are often approved with little testing by the U.S. Food and Drug Administration (FDA), and doctors can be influenced by big pharma to prescribe a certain medication, despite the lack of studies on it.

The latest controversial drug is Pradaxa, which is an anticoagulant used to treat atrial fibrillation, a condition that often affects elderly patients. Pradaxa is similar to Warfarin. Both drugs carry a similar risk of bleeding, but patients who take Pradaxa do not have to undergo the frequent blood tests required for Warfarin.

A major difference between Pradaxa and Warfarin is that unlike Warfarin, Pradaxa has no known antidote, so if a patient on Pradaxa experiences bleeding, his doctor can do little to help stop the bleeding. Recent reports suggest that elderly patients who take Pradaxa and suffer minor falls have an increased risk of experiencing a serious bleeding event.

Since its introduction on the market in 2010, Pradaxa has caused an estimated 260 deaths worldwide due to serious bleeding events. Regulators knew that Pradaxa had no known antidote when they approved the drug, and the FDA continues to allow the drug to be sold, despite incoming reports of serious bleeding events.

Emergency room doctors and surgeons are especially worried about Pradaxa’s dangerous side effects. “We have noted on multiple occasions patients who have ‘bleeding out’ from Pradaxa and our hands are tied. They’re bleeding out all over and there’s absolutely nothing we can do about it…I’m helpless and hopeless when it comes into my emergency room,” says Dr. Bryan Cotton, a trauma surgeon at Houston’s Memorial Hermann Hospital.

The FDA has not said when it will make a decision regarding the safety of Pradaxa, but diligent trial lawyers across the United States are filing lawsuits to hold Pradaxa’s manufacturer accountable for its dangerous drug. Go to www.vanweylaw.com for the latest news on Pradaxa bleeding events and upcoming Pradaxa lawsuits.

Weight Loss Drug Qnexa Linked to Topamax Birth Defects

 Proposed weight loss drug Qnexa has not yet been approved by the U.S. Food and Drug Administration (FDA), but if approved, thousands of children could suffer Qnexa birth defects.

Qnexa Contains Dangerous Drug Topamax

Qnexa is a combination of two drugs that are known to aid in weight loss--Phentermine and Topamax. Phentermine is a stimulant that is used to suppress appetite.  Topamax, generic name topiramate, is a medication approved to treat seizures and prevent migraines.

Doctors have already been prescribing Topamax to women to aid their weight loss.  But many women currently taking Topamax are of child-bearing age. Studies have found that even when women take birth control pills to prevent pregnancy, Topamax reduces the effectiveness of these hormonal contraceptives, increasing the chances that a woman will get pregnant.

Many women who do become pregnant while taking Topamax do not realize that they are pregnant until months after they have been taking the drug.  Additionally, Topamax can cause serious birth defects even if discontinued after the first trimester.

FDA Committee Endorses Qnexa

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted on February 28, 2012 to endorse Qnexa. Qnexa had previously been rejected by the FDA because of its potential to cause birth defects like cleft lips and cleft palates, which can severely affect a baby's growth and development.

Topamax use during pregnancy can increase the risk that a child will have a birth defect by a factor of two to five. But experts think the FDA will still approve Qnexa despite the risk. In the past decade, the FDA has faced intense pressure from healthcare providers to approve a weight loss drug and reduce the high rate of obesity in the United States. Some experts even say the FDA should approve a potentially unsafe weight loss drug, because reversing obesity will outweigh any drug's risk.

Millions of Women May Take Qnexa

If Qnexa is approved as a long-term weight loss drug, potentially millions of women of child-bearing age may take the drug as a way to lose weight.  But Qnexa may also cause birth defects in thousands of children. Yet, big pharma will still yield profits of anywhere between $1 billion and $3 billion for this new lifestyle drug.

Qnexa has already been linked to heart palpitations, memory loss, and suicidal thoughts, along with birth defects.  If approved, Qnexa could become the next dangerous drug to hit the market.

To learn more about lifestyle drugs, big pharma, and the FDA, download my free ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com.

Elderly Pradaxa Patients Most at Risk for Serious Bleeding Events

 When an 83 year-old man went to University Hospital in Salt Lake City, Utah after falling at home and suffering minor trauma, his doctors never imagined he would suffer a Pradaxa serious bleeding event.

Minor Trauma Can Cause a Pradaxa Serious Bleeding Event

A case report featured in the Journal of Neurosurgery details that the 83 year-old man had been prescribed Pradaxa just a month before by his primary care physician who had diagnosed him with atrial fibrillation.  Upon arriving at the hospital, the man exhibited no signs of impairment, and a brain scan showed that he had only small hemorrhages of little concern.

Within just two hours of being admitted to the hospital though, the man’s condition began to deteriorate.  New brain scans showed he was suffering from extensive intracranial hemorrhaging.  His doctors could do little but stand by and watch as he slipped into a coma. 

The neurosurgeons who treated the man wrote this case report to alert other healthcare providers to the fact that Pradaxa has no known antidote.  In fact, the doctors attempted to stop the hemorrhaging in the 83 year-old by giving him intravenous fluids and recombinant factor VIIa, which is often used to clot blood, but both treatments were ineffective.

The authors noted that because Pradaxa is broken down through the kidneys, dialysis may be the only way to reverse the effects of Pradaxa, but because bleeding events happen so suddenly, dialysis is often ineffective to stop the bleeding.

What is Pradaxa?

Pradaxa is an anticoagulant that is widely prescribed to prevent strokes and blood clots in elderly patients with atrial fibrillation.  But these elderly patients are often unstable on their feet and are prone to falling, which can cause minor trauma and major hemorrhaging.  Experts worry that as Pradaxa is more widely prescribed to older, frailer patients, the number of serious bleeding events will increase.

Worldwide, Pradaxa has been linked to 260 deaths as of November 2011.  The U.S. Food and Drug Administration (FDA) released a safety communication for Pradaxa in December 2011, saying that it would study Pradaxa’s side effects to determine the risk of severe bleeding.  In the United States, an estimated 120 deaths have been blamed on Pradaxa serious bleeding events.

While the FDA studies these adverse events, trial lawyers across the nation are standing up for consumer rights, asking manufacturer Boehringer Ingelheim for answers.  Pradaxa lawsuits have been filed in U.S. district courts across the nation, alleging that Boehringer Ingelheim knew about the bleeding risks, but provided no antidote and continued to market and sell Pradaxa anyway.

To learn more about Pradaxa serious bleeding events and get the latest news on Pradaxa, visit www.vanweylaw.com.  Pradaxa is not the first dangerous drug to be approved by the FDA, and it certainly will not be the last.  To learn more about dangerous drug approvals, download my free ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Company Does Not Want You to Know at www.vanweylaw.com

Diabetes Drug Victoza--Weight Loss Miracle Drug or Dangerous Drug?

Video Source: khou.com 

Victoza was first widely publicized and marketed when southern chef Paula Deen made the announcement that she is a diabetic.  Simultaneous with her announcement, Deen endorsed Victoza, saying that the drug has helped her control her diabetes.

But what Deen didn’t know was that Victoza comes with a hefty warning that patients can develop thyroid cancer while taking the drug.

Weight Loss in a “Little Blue Pen”

Nearly two months after Deen’s not so shocking admission, she now says she has lost weight and dropped two sizes thanks to Victoza.  That’s surprising, seeing as how Deen was photographed shortly after her announcement eating a very large cheeseburger while on a cruise.  But part of Deen’s weight loss could also be due to the fact that she has cut her portion sizes in half and has started walking for 30 minutes a day.

While patients taking Victoza have reported experiencing a decreased appetite, the drug's ability to cause weight loss is difficult to predict.  Victoza manufacturer Novo Nordisk says that weight loss is just one of the many “beneficial” side effects of the drug.  Less talked about are the dangerous side effects of Victoza, which include thyroid cancer, pancreatitis, and severe stomach problems.

Although Victoza is only approved to treat Type-2 diabetes, some critics of the drug are concerned that doctors could legally prescribe it to patients who are borderline diabetic to help them lose weight and fend off diabetes.  But whether the benefits of the drug outweigh its dangerous risks remains to be seen.

Similar Dangerous Diabetes Drugs

Other diabetes drugs that are being praised for their weight loss inducing side effects include Byetta, Bydureon, and Januvia.  Yet all of these drugs come with warnings of serious side effects similar to those of Victoza.

For instance, Byetta can cause pancreatitis, which is an inflammation of the pancreas that can be painful and can lead to death if not treated.  Bydureon can cause a type of thyroid cancer known as medullary thyroid cancer (MTC), the symptoms of which are swelling or lumps in the neck, hoarseness, trouble swallowing, and shortness of breath.  Additionally, Bydureon can cause pancreatitis, dehydration leading to kidney problems, and severe stomach problems. Januvia can cause serious side effects like pancreatitis, kidney problems, and hypoglycemia, or low blood sugar.

Additionally, diabetes drug Actos has been shown to cause bladder cancer.

Big Pharma Markets Diabetes Drugs as Lifestyle Drugs

This recent development that Victoza can cause weight loss is just another tool in big pharma’s arsenal to get people to buy their drugs.  Big pharma markets drugs like Victoza, Byetta, Bydureon, and Januvia as lifestyle drugs that will allow people to live their lives as they always have—eating foods high in fat and sugar and not exercising regularly.  Unfortunately, there is no such thing as a “miracle diet drug” and for some patients, the benefits of taking these drugs may be outweighed by the risks the drugs pose, like thyroid cancer.

To learn more about the secrets of big pharma, download my FREE ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com.

Why You Should be Concerned about Nationwide Drug Shortages

In recent weeks, news stories about cancer drugs in dangerous short supply have been capturing headlines across the nation. But few people know that cancer drugs are not the only vital drugs in short supply.

Nationwide, hospitals and ambulance companies have had to ration supplies of hundreds of medications used to treat common injuries.  Some of the most commonly used drugs in short supply are:

  • Midazolam & Valium—used to treat seizures
  • Morphine & Fentanyl—used to treat pain
  • Zofran—used to treat nausea and vomiting
  • Benadryl & Epinephrine—used to treat allergic reactions
  • Mannitol—used to control pressure in patients who have head injuries

In the Dallas-Fort Worth area, paramedics who work for Medstar are using drugs past their expiration dates in some cases, because they simply do not have a stable supply of the medicines.  While the drugs can be made by local pharmacists, they typically do not last as long as those provided by the drug companies.

Attempting to address the shortage, President Obama signed an Executive Order just last year in which he directed the FDA to prevent and reduce the number of drug shortages that have been growing over the past few years. 

Pharmaceutical companies that manufacture these drugs have cut back manufacturing significantly, arguing that they make little profit on these common drugs.  But the Department of Justice has launched an investigation into whether some of these pharmaceutical companies are creating artificial shortages in order to increase demand, and therefore, increase prices.  If pharmaceutical companies have been illegally price-gouging or stockpiling medications, they could face criminal charges.

For now, the FDA is taking steps to protect consumers and prevent price gouging by instituting early notification requirements of potential drug shortages.  Unfortunately, this may be another case of big pharma putting profits before patients and consumer safety.

To learn more about the pharmaceutical industry, download my FREE ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com.