Did Boehringer Ingelheim withhold safety information about blood thinner Pradaxa?

blood cells1 Did Boehringer Ingelheim withhold safety information about blood thinner Pradaxa?When Pradaxa (dabigatran) hit the market in 2010 to prevent strokes in patients with atrial fibrillation, it became the first alternative treatment to the long-used warfarin for patients with the condition. What made Pradaxa so attractive compared to warfarin (Coumadin) is that patients taking Pradaxa did not have to have their blood monitored on a regular basis in order to prevent potentially deadly bleeding events.

However, a British Medical Journal investigation has found that Boehringer Ingelheim, maker of Pradaxa, withheld information that showed patients taking Pradaxa who underwent routine drug level monitoring and dose adjustment could cut bleeding risk by up to 20 percent compared to patients using Pradaxa who were not monitored or had their doses adjusted. Patients using Pradaxa who were regularly monitored and had their doses adjusted accordingly also had a 40 percent reduced risk of stroke compared to patients taking warfarin who were regularly monitored.

Patients with atrial fibrillation are at an increased risk of blood clots and strokes, and are routinely treated with blood thinners to reduce this risk. But blood thinners can cause bleeding events. However, Boehring Ingelheim claimed that Pradaxa was as effective as warfarin at preventing strokes, but safer against bleeding events. As a result, it didn’t take long for sales of Pradaxa to skyrocket.

In 2012, the Food and Drug Administration (FDA) announced that it had conducted a review of safety issues involving Pradaxa after receiving a “large number of post-marketing reports of bleeding among Pradaxa users,” including gastrointestinal bleeds and brain bleeds. At the same time, lawsuits against Boehringer Ingelheim were mounting, claiming the company did not adequately warn patients of the bleeding risks with Pradaxa.

One alarming side note with Pradaxa is that, unlike warfarin, if a patient experiences a bleed, there is no antidote, or reversal agent, to stop the bleed, increasing the chances of a fatal outcome.

The latest report from the British Medical Journal has already caused a stir among medical professionals. “The promise of Pradaxa, and other newer drugs of the same class, was that positive results could be achieved without the variability seen with warfarin, and with no need for routine monitoring. If, in fact, this is not the case, as the investigation suggests, then one of the primary reasons to use this drug would be void. Further, since it would appear that the efficacy is closely comparable, adding the need for monitoring to a branded, that is expensive, drug in favor of the more commonly used generic warfarin would seem to be another impediment to its use,” said Marc I. Leavey, MD, primary care physician, Mercy Medical, Baltimore.

“Not surprising at all. A lot of evidence has slowly been leaked about the harms of this drug that were known and hidden. I think a lot of doctors are going to feel very bad that they ever started these meds. We in the ED have always been very opposed (in general). Easier if you don’t have to monitor but no reversal agent. We’ve seen a number of bad head bleeds on dabigitran,” said Anand Swaminathan MD, MPH, emergency medicine physician, Bellevue/NYU Langone Medical Center, New York City.

Source: Medpage Today