Thursday, March 29, 2012

The Dangers of Pradaxa (Dabigatran): Part 2 of 3: Serious Cerebral and Cardiovascular Risks

Some experts feel that the German pharmaceutical company, Boehringer Ingelheim, rushed their new wonder drug, Pradaxa to the market perhaps a bit too quickly in an attempt to beat the competitors to the mark. Pradaxa subsequently became the first drug to rival Warfarin in over half a century. Boehringer announced that Pradaxa was as much as 35% more efficient in decreasing the risk of serious stroke than Warfarin, and in less than a year there were over a million prescriptions issued for the drug to over 400,000 patients hoping to avoid the negative aspects of Warfarin.

How is Pradaxa Used?

Pradaxa is primarily used for patients suffering from atrial fibrillation and to reduce the risks of stroke. Pradaxa also appeared to offer additional advantages over Warfarin in that there was no need for regular blood level monitoring as well as the fact that Pradaxa users didn’t have to be as concerned with mixing Pradaxa with certain foods and other medications as those taking Warfarin. While Vitamin K antagonists, such as Warfarin, are the mainstay of long-term anti-clotting therapy, there certainly exists a need for newer and safer anticoagulants. Pradaxa and other similar drugs currently undergoing trials use thrombin inhibitors as their primary ingredient; unfortunately the side effects of Dabigatran can be serious or even fatal.

Rushing the Drug to Market

In order to get its drug to market, Boehringer conducted a study of 18,000 patients, however rather than an independent study, this one was paid for by Boehringer, and the doctors who subsequently published glowing reports of the drug in medical journals disclosed at the end of those articles that they received a consulting fee, lecture fee or grant support from Boehringer Ingelheim. Later, doctors began seeing ill effects in Pradaxa users and pointed out that unlike Warfarin no reversal agent existed for the drug. In other words, any patient suffering a catastrophic bleeding event while taking Warfarin would stand a chance of living since Warfarin has an effective antidote. Pradaxa, unfortunately, does not. At this point in time over 260 deaths have been reported in those taking Pradaxa, particularly in older patients or those with a prior history of kidney disease.

Pradaxa and Cardiovascular Risks

While the fact that Pradaxa can cause excessive internal bleeding appears to be the primary risk when taking the drug, there are other potential health risks as well. Recent studies suggest an increased risk of heart attack in patients taking Pradaxa, and one online medical resource, WebMD, reports that when compared to Warfarin Pradaxa posed a 33% increase in the risk of serious heart attack. Even if you believe Boehringer’s statement that there is only a very small increase in the risk of heart attack for those taking Pradaxa, patients who have a history of or prior risk of heart attack may want to reconsider taking the drug.

Another meta-analysis of Pradaxa showed it to be associated with greater odds of myocardial infarction and acute coronary syndrome than control treatments. In fact, in controlled trials, acute coronary syndrome or myocardial infarction occurred at a significantly higher rate in those taking Pradaxa. Although Pradaxa appears to reduce the risk of stroke, for those with any indication or history of cardiovascular incidents, Pradaxa may not be the best choice.

Pradaxa’s Connection to Cerebral Hemorrhage

Bleeding in the brain is also known as a cerebral hemorrhage and is a type of stroke which occurs when a brain artery bursts, leaking blood into the surrounding brain tissues. When this blood comes into contact with brain tissue, it causes those tissues to become irritated and swell up. The blood also disturbs brain cells, in many cases leading to irreparable brain damage. Once the blood pools it can form a hematoma which in turn causes pressure inside the skull. One of the primary causes of a brain hemorrhage is head trauma from a fall. Since falls are common among the elderly, and because nearly half of all people hit their head when they fall, cerebral hemorrhages become more likely.

When an elderly person is taking Pradaxa and hits their head in a fall, the bleeding may become excessive, leading to death. In fact a Journal of Neurosurgery report detailed the death of an 83-year-old Pradaxa patient who suffered a relatively minor fall and later died of a cerebral hemorrhage. When the man arrived at the hospital he was awake and alert, and a CT scan indicated only a small area of bleeding on the brain. The man was given IV fluids and a protein which encourages blood clotting, however the doctors were unaware the man was taking Pradaxa and the protein would be completely useless. Blood soon filled the entire left side of the elderly patient’s brain, causing him to become comatose and die.

How Pradaxa Works

Because the drug Dabigatran is more consistently absorbed in an acidic environment, Boehringer took the unusual stance of applying the Dabigatran coating to the outside of a tartaric acid core to form the tiny pellets which are then placed in a capsule. This ensures that the absorption of the Dabigatran is not dependent on the gastrointestinal acidity of the individual patient rather the tartaric acid core creates its own acidic environment. In theory, this decreases the variable of the individual patient’s gastrointestinal pH environment. Unfortunately the acidic core of the Pradaxa capsule can cause gastrointestinal disturbances among Pradaxa users. Many users experience bloating or an uncomfortable, overly full feeling in their stomach while taking Pradaxa while others suffer heartburn, nausea and diarrhea.

If you or a loved one experience any type of unexpected or unexplained bruising, swelling or pain in the joints, discolored urine (pink or brown), bleeding from the gums or red or black stools, this is definitely cause for alarm and requires a visit to your physician. If you feel you have been harmed from taking Pradaxa, it is important to seek medical help from a qualified physician.

Author: Sullo & Sullo Attorneys

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