I-Team: Pradaxa memo indicates side effects not shared with patients

Safety concerns kept secret

NORTHPORT, Fla. - You take them to lead healthier lives, but the side effects of all prescription drugs kill more people than homicides or car accidents.

And we've discovered what some experts say is a controversial drug on the market, a blood thinner blamed for more than a thousand deaths and even more life-threatening hemorrhages.

Don Mullen stays busy selling Gulf Coast real estate, but a recent medical scare could have sidelined him for good.

“One morning, I just didn't feel right. I felt lighted headed,” Mullen said.

Mullen's doctor told him to immediately get checked out, so he drove seven miles to an urgent care center in Sarasota County where he says he was diagnosed with internal bleeding.

“They did some testing and said you are down three quarters of your normal blood level,” said Mullen. “They asked me how I got there and I said I drove. They said, 'That's amazing that you're even conscious.'"

Every step is a struggle for Inez Brest, who suffered a severe bleed in her brain in April.

"My head was on fire. It was a real God awful feeling. It was like it was burning in there," Brest said.

Both Mullen and Brest were taking Pradaxa.

And both blame their injuries on the blood thinner.

We discovered the Food and Drug Administration received more complaints about Pradaxa than any other drug in  2011 and 2012.

Since it was approved in 2010, the drug has been blamed for more than 12,000 serious injuries and more than 1,100 deaths. 

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

"It's a great tragedy in medicine in the regulation of drugs," said Tom Moore, a scientist at the nonprofit Institute for Safe Medication Practices, which monitors FDA reports.

“There was an opportunity to make it safer. Instead it appears it the commercial instincts to sell more drugs won out,” said Moore.

Earlier this month, as a result of a court order, Boehringe Ingleheim, which makes Pradaxa, released documents revealing that the company knew elderly patients could have a higher bleeding risk.

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

The documents reviewed by the I-Team also show regular blood tests could help manage those risks.

But in an internal memo, a supervisor with the company wrote that requiring monitoring would hurt sales, saying it   "would undermine our efforts" to compete with other blood thinners.

Pradaxa went on the market with no monitoring recommendation.

"I miss my brain. I miss all the knowledge that I learned. I was a speed reader. Now I'm not,” Brest said.

She and Mullen are among 2,300 patients suing Boehringe Ingleheim for failing to warn them.

Mullen is thankful to still be around.

“I enjoy life to the fullest,” he said.

Brest hopes to enjoy life again one day.

"I just keep praying that God will put me back like I was, because I was so happy before,” said Brest.

The FDA and Boehringer Ingelheim say when it comes to Pradaxa patient safety is a priority.

"Like any blood thinner, it can sometimes lead to serious bleeding complications," the company says in a statement. "Boehringer Ingelheim presents clear and accurate information about those benefits and risks to physicians and patients."

If you or a loved one is taking Pradaxa or another blood thinner, experts say don't stop taking your medication. In most cases, the benefits of taking a blood thinner far outweigh the risks.

But do call your doctor and discuss your concerns.

Full response from Boehringer Ingelheim:

“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.”

Full response from FDA:

“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; http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm ) 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).


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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