New Study Suggests Increased Risk to Heart Patients Taking Digoxin Medication

There's more bad news in this morning's headlines for people suffering heart problems.  According to a new study in the European Heart Journal, as reported by CBS News, the heart medication digoxin has caused increased deaths in atrial fibrillation patients.  In a group of already high risk patients, a potentially faulty treatment could mean a death sentence for some.

The Dangers of Atrial Fibrillation

The U.S. Centers for Disease Control estimate that approximately 3 million people in America suffer from atrial fibrillation and as many as 12 million people could develop this heart condition by 2050. These patients suffer from an abnormal heart condition which causes irregular heart beats and puts affected patients at risk for blood clots and strokes.

Risk factors for atrial fibrillation include:

• high blood pressure
• heart failure
• diabetes
• hyperthyroidism
• old age
• congenital heart disease
• heart defects

Patients seeking to control their atrial fibrillation have multiple options available to them.  Patients can take medication to strengthen the heart beat and try to normalize the rythym, take blood thinner medication to prevent blood clots, have surgery, or make serious lifestyle changes like losing weight and lowering blood pressure.  But unfortunately, the CDC reports the rate of death has been increasing for the past two decades.

The Digoxin Study Cites Increased Death Rates

In a study spanning over 3 years, researchers studied atrial fibrillation patients who took digoxin and compared how they did following treatment, including an examination of death certificates.  What they found was a 41% increase in deaths among patients taking digoxin.  These patients experienced a 35% increase in cardiovascular deaths, and 61% increase in deaths from specific heart beat related problems like arrhythmia.

If these figures are accurate, atrial fibrillation patients could be at serious risk of death over patients who may have opted for other forms of treatment.  But given the amount of news surrounding treatments like anti- coagulant medications, it appears to be par for the course in atrial fibrillation treatments.

If You Have Been Injured By Your Heart Medication

Unfortunately, if you're taking heart medication, you could be at serious risk for injury.  This could be devastating and deadly.  Patients are encouraged to speak to their doctor regarding the safety of their medications and to discuss any changes in treatment.  But if you have suffered a heart medication injury, you should speak to a skilled product liability and personal injury lawyer. 

FDA's Pradaxa Study May Be Flawed & Misleading

Year Long FDA Pradaxa Study May Be Deeply Flawed

Over 500 people have died from the popular blood thinner drug, Pradaxa.  As reported deaths rose, the U.S. Food and Drug Administration (FDA) began a year long investigation into the drug and its effects upon the human body.  As a result, the FDA released its conclusions last week, stating Pradaxa was no more dangerous than other blood thinner medications like Warfarin.  But new evidence suggests that this study may have reached premature conclusions and may have been deeply flawed.

In September, the Journal for the American Medical Association (AMA) declared the release of Pradaxa may have been too premature.  Studying the initial trials, the AMA expressed concern for the many internal bleeding events that went overlooked when this drug was approved by the FDA.  Similarly, USA Today reported in August that the FDA had received 3,781 complaints of adverse health effects and over 542 deaths attributed to Pradaxa.  For the FDA to ignore these complaints and classify the drug as no more dangerous than its competition seems suspicious to some health experts.

Were the FDA's Conclusions Merely Guesses?

Critics state the FDA has failed to take the incidents of internal bleeds into account and the fact that Pradaxa has no reversal agent, unlike other blood thinner medications.  Doctors have been quick to point out that the FDA's methodology appears to be flawed.  The FDA has been using unadjusted incident rate ratios to determine Pradaxa's safety, which leading medical authorities have found severely lacking.

This alleged flawed methodology is important because in some instances, it compares drug outcome pairings where there is no causal relationship.  Medical researchers state that this amounts to little more than a guess or a shot in the dark.  Researchers further point out that the comparisons seem to be skewed towards drug outcome pairs with known causual relationships such as Warfarin.  In a very real sense, it seems Warfarin's reputation is skewing the results unfairly.

If You Have Been Injured By Pradaxa

Despite this FDA study, the Institute for Safe Medical Practices reports Pradaxa is among the drugs responsible for a 37% increase in prescription drug complaints.  Because of the high number of Pradaxa injury complaints, the litigation against Pradaxa drug maker Boehringer Ingelheim is expected to be complex and lengthy.  Federal Judge Herndon in the Southern District of Illinois has issued an order on July 24, 2012 authorizing patients injured by Pradaxa to proceed with multi-district litigation in case number MDL No. 2385, IN RE: Pradaxa Product Liability Litigation. 

If you have been injured by Pradaxa, please call an experienced product liability attorney.  Your blood thinner injury could be severe enough to affect your entire life and your quality of life.  In order to protect your rights and gain the compensation you need, you should speak with a skilled product liability attorney today.

New Study Claims Prescription Sleep Aids Risky

Are You at Risk of Death from Prescription Sleep Aids?

A new study published in BMJ Open links a five- fold increase in risk of early death with taking prescription sleep aids such as Ambien.  With over 16 million Americans prescribed Ambien on a yearly basis, these are disturbing figures.  Researchers at Scripps Health in San Diego estimate that in 2010, prescription sleep aids such as Ambien accounted for up to half a million “excess deaths” in the United States.  This was inclusive of not only frequent users, but also the occasional user who took fewer than 2 pills a month.  These infrequent users were still 3 times more likely to die early than non- users.

"We thought maybe sleeping pills are being prescribed for sicker people, so we tried to take that out of the mix in several different ways," the study’s author, Robert Langer said. "The risk was the same whichever way we looked at it. To me, that was the most startling finding. It blows things like high cholesterol or diabetes out of the water."

 

The Evidence is Mounting Against Prescription Sleep Aids

This study adds to the mounting body of evidence that sleep aids such as Ambien are unsafe.  Similar results were obtained in a 2009 Swedish study following several thousand men and women over a 20 year span.  The study found that men who were frequent users were 4.5 times more likely to die early while women were twice as likely to die early.  And a 2010 Canadian study found prescription sleeping pill users were nearly twice as likely to die early as non- users.

Over 70 million Americans report problems with insomnia every year.  In response, doctors have advocated solutions such as Ambien (zolpidem tartrate), a hypnotic sedative generally used as a sleep aid.  This powerful sleep aid is notorious for serious side effects and dangerous consequences including dependency and overdose. Millions of Americans routinely use Ambien and other sleep aids as a habit. Even when taken as prescribed, there are a number of associated side effects that can include: suicidal thoughts, anxiety, depression, emotional instability, double vision, parasomnia or the continued action during semi- consciousness, muscle and joint pain, nasal and throat irritation, constipation, and amnesia. 

If you have lost a loved one to prescription sleep aids, you may be entitled to compensation.  Please call our law office today for a free and confidential consultation.  

Do I Have a Pradaxa Case

To patients suffering with atrial fibrillation, blood thinner medication can be life saving.  By stopping potentially fatal blood clots from forming, patients are able to avoid strokes and heart attacks.  However, the latest blood thinner medication to come under scrutiny has been Pradaxa. 

Sold as a new and improved version of Warfarin, Pradaxa was supposed to thin the blood and require less doctor oversight.  Instead of blocking Vitamin K production like Warfarin and similar drugs, Pradaxa worked by inhibiting thrombin, the clotting agent in the blood. Unfortunately, because of this significant difference, if patients experienced fatal bleeds, they could not clot the blood with a shot of Vitamin K.  In fact, Pradaxa had no reversal or clotting agent to offer patients.

If You Have Been Injured By Pradaxa

Pradaxa patients could face serious and lasting injuries as a result of taking their medication as prescribed.  This could include:

·         Potentially fatal bleed outs

·         Increased risk of heart attacks

·         Increased bleeding in the kidneys

·         Bleeding in the brain

·         Purple spots under the skin, abnormal bleeding from the gums, mouth, vagina, and rectum

·         Blood in your urine or stools

·         Coughing up blood or vomit

·         Intestinal bleeding, ulcers

·         Death

How Strong Is Your Pradaxa Case

If you've suffered adverse reactions to Pradaxa, your product liability attorney will want to know whether these began before or after January, 2012, when the FDA mandated changed warning labels. Incidents occuring prior to January 2012 are likely to lead to a stronger case than those experienced after the FDA mandated changed labels.

Patients who suffered the following will have stronger cases:

·  gastrointestinal bleeds

·   a hemorrhagic stroke


· trauma-induced atypical bleeding event

· death


It is important that you seek medical help for any Pradaxa injuries first.  And when you're well, seek the skilled advice of a product liability attorney. 

FIFTY YEARS AFTER THALIDOMIDE CAUSED BIRTH DEFECTS, MANUFACTURER APOLOGIZES

You could certainly file this one under too little, too late.  Fifty years after the morning sickness drug, Thalidomide, caused birth defects, its German manufacturer, Grünenthal, apologized.  In a brief apology ceremony, the manufacturer, who had largely been silent about its dangerous drug for FIFTY YEARS unveiled a statue of a child with shortened arms and said simply, they offered “our sincere regrets about the consequences of Thalidomide and our deep sympathy for all those affected.”

For those of you who remember, in the 1950’s and 1960’s, Thalidomide was the newest hottest drug that was touted as the answer to solving women’s morning sickness.  And then expectant mother after expectant mother began to give birth to children with birth defects.  These children were born with shortened and malformed arms which prompted many journalists to call them “flipper babies.”

This heartbreaking situation has been a case study in what NOT to do.  Fifty years of silence and a slap dash ceremony does not inspire trust in a pharmaceutical company.  Nor does it inspire forgiveness.  In fact, recent headlines echo the same sentiment: survivors reject the apology.

COULD THIS BE THE RESULT OF THE SSRI ANTIDEPRESSANT LAWSUITS

The major manufacturers of serotonin reuptake inhibitorantidepressants  (SSRI’s) like Zoloft, Paxil, Prozac, Celexa, Lexapro, Luvox, and Viibryd could very well take some lessons in this situation.  Address your victims now.  Don’t let fifty years go by before you apologize.  You may find that your audience won’t be as accepting or welcoming of your apology.

SSRI’s are currently facing their first waves of lawsuits, where attorneys are presenting case after case of expectant mothers who have given birth to children with birth defects as a result of taking their drug.  When the lawsuits are done and the dust settles, will the drug manufacturers step up and do the right thing?

IF YOUR MEDICATION HAS CAUSED YOU TO GIVE BIRTH TO A CHILD WITH BIRTH DEFECTS

If you’re a new parent who has given birth to a child with birth defects, it may be your medication that caused it.  Have a frank and honest discussion with your primary care physician and discuss the medications you or your loved one may have taken during pregnancy.  If you were unaware of the side effects that these medications produce, you’re not alone.  And you may be entitled to compensation.  If you’d like to discuss your options, call our law firm today and we’ll guide you through the process.  It may not be enough for you to get an apology fifty years too late.