Why You Should be Concerned about Nationwide Drug Shortages

Dallas drug injury attorney explains how a nationwide drug shortage could put people in danger if they are not able to receive medicines used to treat common injuries.

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.

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FDA’s Yaz Panel Influenced by Big Pharma

Four experts who served on the FDA’s Yaz panel on December 8, 2011 had ties with manufacturer Bayer, some of them financial. Consumer advocates are now calling on the FDA to take another look at Yaz and Yasmin.

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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Yaz Increases Blood Clot Risk by 75%

The FDA recently released data from studies showing that women taking Yaz, Yasmin, or other drospirenone-containing birth control pills are 75 percent more likely to experience a blood clot while taking the pills than women taking traditional birth control pills.

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 8th 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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Google Pays $500 Million in Settlement for Online Pharmaceutical Ads

Google, Inc. has agreed to pay the U.S. government $500 million to settle claims that it improperly profited from selling advertisements to Canadian pharmacies that illegally import drugs into the U.S., potentially harming consumers.

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.

 
If you are lucky enough to have health insurance, then some of your costs associated with filling a prescription are paid.  But if you are one of the more than 50 million people who are uninsured in this country, you are forced to pay for prescriptions at full price.
 
In the last few years, people have turned to Internet pharmacies to get their prescriptions for a reduced price.  But under U.S. law, foreign pharmacies cannot legally ship prescription drugs to consumers in the United States if they are not first approved by the FDA.  The worry is that because these drugs are not approved by the FDA, they are potentially dangerous to consumers.
 
Google, Inc. learned this lesson the hard way when it sold advertisements to Canadian pharmacies that were illegally selling prescription drugs to American consumers.  Rather than face criminal prosecution for allegedly improperly profiting from these advertisements, Google agreed to pay the U.S. government $500 million in a settlement.
 
Sales of online advertisements for health care services and products generate nearly $1.3 billion each year.  Google’s ad sales helped the company generate $39 billion in cash by the end of June 2011.
 
Critics worry that this slap on the wrist for Google will not do much to help consumers who have their health compromised by these illegally imported prescription drugs.  And while U.S. officials continue to track down companies that endanger the health of U.S. citizens, America cannot seem to escape its growing prescription pill problem.
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FDA Warns that Actos May Cause Bladder Cancer

The FDA has issued a warning to patients taking the popular diabetes drug Actos that they may be at a 40 percent increased risk of developing bladder cancer.

Dallas dangerous drug attorney Kay L. Van Wey explains the FDA's most recent warning about diabetes drug Actos

According to a recent report by the Centers for Disease Control & Prevention (CDC), as many as a third of Americans could have diabetes by the year 2050.  This estimate is based on the fact that people are living longer and are gaining more weight.
 
Strides have been made in combating diabetes, but newer prescription drugs to help patients deal with Type 2 diabetes have had dangerous side effects.
 
In 2010, the popular diabetes drug Avandia was sharply restricted by the FDA when researchers found that it caused heart attacks and strokes.  With Avandia off the market in Europe and restricted in the United States, Actos became the most popularly prescribed diabetes drug.
 
Between January 2010 and October 2010, an estimated 2.3 million patients filled prescriptions for products that contained pioglitazone, the main ingredient found in Actos.
 
But recently, the FDA has found that Actos has its own problems.  In a study conducted by the FDA, patients taking Actos for one year or longer had a 40 percent increased risk of developing bladder cancer.  This finding was enough for the FDA to issue a warning to doctors not to prescribe Actos to patients with active bladder cancer and to use caution in prescribing to patients with a prior history of bladder cancer.
 
Another study conducted in France has also suggested that patients have an increased risk of developing bladder cancer while taking Actos.
 
If you have been taking Actos for one year or longer, the FDA recommends that you continue taking the drug until you can talk with your doctor about potential alternative treatment options.
 
While on Actos, you should consult your doctor if you experience blood or red-colored urine, an urgent need to urinate or pain urinating, or pain in the back or lower abdomen.
 
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FDA Warns Celexa May be Dangerous to the Heart

The FDA has released new prescribing guidelines for doctors regarding the popular anti-depressant Celexa. Doctors can no longer prescribe the drug in doses over 40mg, and are warned against prescribing the drug to patients with known heart conditions.

Dallas dangerous drug attorney talks about new dangers of Celexa

Celexa (generic name Citalopram Hydobromide) is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression by increasing serotonin in the brain to improve mood. But based on recent studies showing that Celexa poses heart-related risks, the Food and Drug Administration (FDA) has restricted the dosage at which Celexa may be prescribed.

The FDA made the label change after studies showed that Celexa causes abnormal heart rhythms and has no therapeutic benefit when taken at a high dose.  Doctors will no longer be able to prescribe the drug at doses higher than 40mg.  Generics of Celexa are also included in the label change. 

Patients at risk for experiencing an adverse cardiac event while on Celexa include those with underlying heart conditions and those with low levels of magnesium and potassium in the blood.  Doctors are not to prescribe the drug to patients with congenital long QT syndrome (CQTS), a condition which affects the electrical system of the heart and can lead to cardiac arrest or sudden death.
 
The FDA recommends that patients taking Celexa consult their doctor before discontinuing the medicine, as serious side effects may occur after discontinued use.  If you are currently taking Celexa and are experiencing a shortness of breath, irregular heartbeat, or dizziness, the FDA recommends you see a doctor right away.  Report any adverse events experienced while on Celexa to the FDA’s MedWatch Program at 800-332-1088.
 
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Tylenol Lowers Daily Recommended Dose

Johnson & Johnson has recently lowered the daily recommended dose for its popular OTC drug, Extra Strength Tylenol. The drug, which contains acetaminophen, has been shown to cause liver failure when patients overdose on it.

Tylenol! Pictures, Images and Photos

Do you take over-the-counter (OTC) pain medications daily at the maximum recommended dosage?  If so, you may be over-medicating yourself.  

Johnson & Johnson, the manufacturer of the popular OTC pain pill Tylenol recently announced that it would be reducing the recommended dose of its Extra Strength Tylenol from 4,000 mg or eight pills a day to 3,000 mg or six pills a day.  Tylenol contains acetaminophen, which is found in more than 600 medicines, including Alka-Seltzer, Nyquil, and Sudafed.   People mixing these medicines often unknowingly overdose on acetaminophen.
 
So why is Johnson & Johnson changing its dosing instructions now?  More than 56,000 Americans are hospitalized each year after overdosing on acetaminophen, which can cause liver failure.  In fact, acetaminophen overdoses are the leading cause of liver failure in the United States and lead to nearly 458 deaths each year.
 
Because acetaminophen is found in so many other OTC products, Johnson & Johnson thought it would be best for consumers if the company lowered the daily recommended dose.  New labels on Extra Strength Tylenol with the reduced dosage will start rolling out this fall.  Next year, Johnson & Johnson will also change the dosing instructions on its regular Tylenol.
 
While health experts are praising Johnson & Johnson for voluntarily changing the labels to reflect the lower recommended dosage, they are also worried that companies that produce similar OTC products are not informing consumers sufficiently about these medicines and how they may interact with other medicines.
 
Beginning as early as 2009, some medical experts called on Johnson & Johnson and the Food & Drug Administration (FDA) to lower the recommended dose to as little as 2,600 mg per day.  They also urged the major pharmaceutical company to require a prescription be written for Extra Strength Tylenol 500 mg.  Neither of these changes were made at the time, and Extra Strength Tylenol is still available as an OTC medication.
 
In recent years, Johnson & Johnson has suffered major setbacks in manufacturing several of its popular OTC drugs.  Just this year, the company recalled 43 million packages of Tylenol, Benadryl, Sudafed, and Sinutab products because the equipment used to produce the drugs was not sufficiently cleaned.
 
Even with “safe” OTC drugs on the market, pharmaceutical companies need to help consumers understand what ingredients are in the medicines they are taking, how those interact together, and the maximum dosage of each drug they should be taking per day.
 
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FDA Issues New Warning Label for Chantix

Chantix was approved by the FDA in 2006 for patients who wanted to quit smoking. Since then, several studies have linked the use of Chantix to suicide, depression, and an increased risk of having an adverse cardiovascular event. The FDA has now issued a new warning regarding the risk the drug poses to patients’ cardiovascular health.

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We’re all hoping for that miracle pill.  You know, the pill that will make us thinner without having to diet or workout, the pill that will get rid of fine lines and wrinkles, or the pill that will help us quit smoking. Unfortunately, there is no such thing as a miracle pill.  
 
Sure, some prescription drugs are helpful and can give us a better quality of life, if used correctly. But some prescription drugs have proven to be dangerous to our health, reducing our overall quality of life.
 
One such dangerous pill is Chantix (generic name Varenicline), touted by major pharmaceutical company Pfizer as the pill that would help people quit smoking.  The Food & Drug Administration (FDA) approved the drug in 2006 to help people quit smoking.  But recent studies suggest that Chantix may put its patients at an increased risk of a heart attack, even if a patient has never had prior heart problems or cardiovascular disease.  These results have prompted the FDA to include a warning on the box regarding potential cardiovascular-related health effects.
 
In 14 studies conducted over the past five years, researchers found that 72 percent of the more than 8,000 patients studied had an increased risk of being hospitalized with a heart attack or serious heart problem, compared to those taking a placebo.  Smokers taking Chantix who had never had heart disease were at a 150 percent increased risk of experiencing an adverse heart event.
 
These results are troubling to many doctors, especially since Chantix is supposed to help reduce the risk of heart attack that comes from smoking.  Researchers now believe the drug is doing exactly what it’s trying to prevent.
 
Some doctors have had concerns about the drug dating back to its release on the market in 2006.  Dr. John Spangler, a co-author of the new research findings, says he raised concerns about the drug and its effect on the heart in 2006 during the drug’s approval process, but that his warnings were ignored by both the FDA and Pfizer, meaning neither patients nor physicians were warned of the risk at the time.
 
When asked why the FDA did not see fit to warn doctors and patients about the drug’s risks in 2006, it responded that the data at the time was too inconsistent for a warning label.  Since its approval, Chantix has been the subject of several FDA safety reviews, including one for depression and suicide.  In 2009, the FDA issued a black box warning, the strongest warning issued by the FDA, regarding the risk of depression and suicide for patients taking Chantix.
 
Only recently has the FDA seen fit to issue a new warning, after findings from a 2010 study conducted by Dr. Nancy Rigotti, a professor at Harvard Medical School and the director of Mass General’s Tobacco Research & Treatment Unit, found that there is an increased risk of adverse cardiovascular events in patients taking the drug.
 
Sales of Chantix topped $755 million in 2010, putting 13 million people worldwide and seven million in the United States alone at risk for depression, an adverse cardiac event, or even a loss of consciousness, visual disturbances, violent outbursts, or a worsening of diabetes.
 
With the new warning, doctors are limiting or discontinuing the use of Chantix by their patients.  Dr. Jay Cohn of the Rasmussen Center for Cardiovascular Disease Prevention at the University of Minnesota is in favor of the FDA’s new warning, saying “[t]he data . . . justify a black box warning on Chantix labeling about cardiovascular risk.”
 
Pfizer disagrees with the results of the studies relied upon by the FDA, but must turnover all of its data regarding adverse cardiovascular events to the FDA.  Chantix serves as a reminder that a pill cannot cure everything.
 
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Lipitor More Effective than Zocor

In a recent study, high dose statin drugs were found to increase a person’s risk of getting type-two diabetes. Researchers from that study are now saying Lipitor should be prescribed over Zocor (generic Simvastatin), despite the higher cost of Lipitor.

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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.

 
This finding comes on the heels of the FDA announcement that Zocor’s labeling would be changed to reflect newer restricted prescribing practices of the drug.  Zocor and its generic, Simvastatin, will no longer be prescribed at the 80 mg dosage to patients who are new to the drug.  And patients taking certain other drugs may have to limit their intake of Zocor because of possible adverse drug reactions.
 
Where patients do need a high dose of statins though, doctors may have to chose the pricier Lipitor, which costs $1.20 a day, over generic Simvastatin, which costs a mere $0.04 a day.
 
Over the five-year study, researchers found that more than eight percent of participants developed diabetes, while 20 percent of patients had a major heart problem.  The study did not look at the recent findings by the FDA that 80mg Simvastatin can cause severe muscle damage and deterioration.
 
Professor Kausik Ray of St. George’s University noted that patients already taking high doses of statins should not stop taking these drugs, but should be monitored by their doctors more closely.  But he reiterated that “[t]he net benefit of Simvastatin is clearly very low and patients on Simvastatin 80 mg should be moved to Atorvastatin 80 mg instead.”
 
Unfortunately, for those without health insurance, Lipitor will be more costly than Simvastatin.  “I don’t think we can wait for loss of [Lipitor’s] patent to stop using Simvastatin 80 mg,” Ray said.  
 
Lipitor is scheduled to lose its U.S. patent protection this coming November.
 
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Zocor’s Harmful Side Effects

Zocor, generic name Simvastatin, has been shown to cause severe muscle damage in patients taking the 80mg dose. If you think you may have suffered severed muscle damage from taking Zocor or its generic equivalent, contact Van Wey Law today.

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Zocor (generic Simvastatin) is a drug prescribed to lower cholesterol in patients with high cholesterol.  The drug was first introduced on the market in 1991 by major pharmaceutical company Merck.  But nearly 10 years later, after studies showed a risk of patients developing severe muscle damage, or rhabdomyolysis, the FDA required Merck to put a warning on Zocor’s label explaining the risk for muscle injury in patients taking 80mg, the highest dosage of the drug.

Further studies since then have shown that the higher the dosage of Zocor a patient takes, the more likely he or she is to develop some form of muscle damage.  Patients who develop rhabdomyolysis, the most severe form of muscle damage, are at risk for kidney failure and even death.

If you are currently taking Zocor, Vytorin, or one of Zocor’s generic equivalents, and you develop sudden unexplained muscle pain, you should contact your healthcare professional immediately. 

Other signs of rhabdomyolysis include dark or red urine, weakness, muscle stiffness or aching, and muscle tenderness.  Additionally, patients with the condition may experience fatigue, weight gain, seizures, and joint pain.

If you or a loved one took or are taking Zocor, Vytorin, or any generic equivalent of Simvastatin and have experienced severe muscle pain or have been diagnosed with rhabdomyolysis, contact Van Wey Law today.
 

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