Investigation: Pradaxa most complained about U.S. drug; blamed for deaths, life-threatening injuries

A new investigation on Pradaxa , a popular blood thinner, revealed that it is the most complained about drug in the United States.

We found more complaints were filed with the FDA about Pradaxa than any other prescription drug in both 2011 and 2012.

Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a non-profit organization that monitors FDA reports.

The drug is used to treat atrial fibrillation, a heart condition that significantly increases the risk of stroke.

"We've found that this drug had a potential benefit in preventing stroke, but it also had extremely high risk of bleeding as do some other anti-coagulants,” said Moore.

Court Order Reveals Hidden Documents

Earlier this month, as the result of an Illinois court order, documents were released that revealed the drug’s manufacturer, Boehringer Ingelheim, performed a study that showed a small minority of patients could have a higher bleeding risk .

The documents also show the German based company knew regular blood tests could help manage the bleeding risk.

However, in an internal e-mail , a supervisor expressed concern requiring monitoring could hurt sales.

Dr. Jutta Heinrich-Nols writes “Is it really wanted to publish this?” and “This will make any defense of no monitoring . . . extremely difficult . . . and undermine our efforts to compete (with other blood thinners.)”

The FDA approved with no requirement for regular monitoring.

"It's a great tragedy in medicine in the regulation of drugs,” said Moore.

"There was an opportunity to make it safer, instead it appears the commercial instincts to sell more drugs won out,” he said.

“This drug now needs to be reassessed and it's not clear that it is safe,” he said.

Patient speaks out on injuries

Inez Brest, 71, agrees. The Amherst grandmother suffered a severe cerebral hemorrhage last April after taking Pradaxa a few months.

 "All of a sudden, I had this huge, like it sounded like it went ‘Pow!’ It was like my brain exploded, she said.

“My head was on fire. It was a real god awful feeling. It was like it was burning in there,” said Brest.

Brest now uses a walker and has significant memory loss. “I miss my brain,” she said.

Michael Timko, 67, of Lorain also blames Pradaxa for his injuries.

He has become homebound after experiencing a gastrointestinal hemorrhage in April 2012.

"Even my worst enemy, i wouldn't want to put them in the position I'm in right now,” he said

His wife, Jean, said her husband is completely dependent on her and their daughter.

"He can't take our grandson fishing, that's the one thing he's talked about. He'd love to take Mikey fishing and he can't take Mikey fishing,” she said.

"He doesn't deserve the life he's living now,"  she said.

Brest and Timko are among 2,304 former Pradaxa users who have filed lawsuits in federal court against Boehringer Ingelheim for failing to warn them.

To see the prescribing and patient information for Pradaxa, click here

Boehringer Ingelheim Response

When we reached out to Boehringer Ingelheim for a comment, a spokesperson sent the following statement:

“Patient safety is Boehringer Ingelheim’s  top priority. Pradaxa is used to reduce the risk of stroke in patients with non-valvular atrial fibrillation, but like any blood thinner, it can sometimes lead to serious bleeding complications.  Boehringer Ingelheim provides clear and accurate information about those benefits and risks to physicians and patients so they can jointly make the best medical decision for the patient.”

FDA Response

An FDA spokesperson sent the following statement on the situation:

“Following the approval of Pradaxa (dabigatran), the FDA received a large number of post-marketing reports of bleeding in Pradaxa users into the FDA’s Adverse Event Reporting System (FAERS). We undertook a safety review to try to assess whether the reports of bleeding were occurring more commonly than expected or were associated with use of Pradaxa that was not consistent with the labeled recommendations (i.e., dose not adjusted for renal function). Several safety reviews have been completed over the past few years (see FDA’s Drug Safety Communication issued Nov. 2, 2012; ) and, in general, we have not identified any unrecognized risk factors for bleeding, and there was no indication that Pradaxa was not being used in accordance with the label.

The FDA is continuing to review Pradaxa as part of our ongoing drug safety efforts for the product (including Mini-Sentinel assessment findings, clinical trial data, and post-marketing reports).

The FDA’s decision to approve Pradaxa was based on a benefit-risk assessment of the totality of data presented in the New Drug Application. Each product’s drug labeling (particularly the package insert text) is developed during, and following,

the completion of the drug review to communicate the essential findings of the review with regard to safe and effective use of the drug product. The FDA is constantly examining product labeling to make sure the label reflects the current scientific knowledge with regard to the benefits and risks of the product.

As explained in our drug safety information about Pradaxa, Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly.  Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes.  The risk of bleeding is a well-recognized risk of anticoagulant drugs. Pradaxa provides an important health benefit when used as directed.  The FDA recommends that health care professionals who prescribe Pradaxa carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their health care professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke, which can lead to permanent disability and death.

The FDA's safety assessment of medicines does not stop after drugs are approved. Although the premarket trials phase of study is very intensive, much work still remains to monitor approved drugs over time. No drug is risk-free, and it is not uncommon for new information to be discovered after a drug is on the market and being used by larger numbers of patients. Such information helps provide a better picture of drug risks, enables the FDA to give health care professionals and patients the latest information on potential or newly identified risks. As we learn more information about a drug, the FDA will update product labeling and alert the public to any new recommendations.”


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