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There are real consequences to post-market drug investigations such as the ongoing investigation of Pradaxa, Boehringer Ingelheim’s new blockbuster drug used in the treatment of atrial fibrilation. In the first year Pradaxa was on the market, at least 500 people reported serious bleeding events as a result of Pradaxa use. The FDA is evaluating these post-marketing reports, but in the meantime, people suffer injury because they are unaware of the risks they take while on Pradaxa.

According to a recent FDA Drug Safety Communication, the FDA is working closely with Boehringer Ingelheim to evaluate the post-market reports of serious bleeding events associated with Pradaxa. In fact, Boehringer Ingelheim is legally obligated to report adverse events to the FDA in an expedited manner. However, until the FDA takes action, there is no requirement that Boehringer Ingelheim make any of these reports public – so they don’t. In fact, to date, Boehringer Ingelheim has only acknowledged 260 bleeding events, although many suspect the actual number of bleeding events to be much higher.

Post-marketing adverse “reports” come in the form of real stories of real individuals harmed in real ways, and we have heard enough of them.

Notwithstanding the reports of injuries, Boehringer Ingelheim reports that more than 350,000 people have been prescribed Pradaxa in the first ten months following FDA approval. The company expects this number to continue to increase as a result of their direct-to-consumer advertising, which focuses on the easier dosing regimens and directs the consumer to “ask your doctor about Pradaxa.”

While we fully understand the academic conversation about the risk and benefit of a drug, it is essential to remember that real people are impacted while this academic discussion continues. Our intent is to bring to light what actually happens while drugs are being investigated after they have been approved. If you or a loved one have experienced any of the following while using Pradaxa tell the FDA, tell the manufacturer, and consider talking to an attorney.

  • unusual bleeding from the gums
  • nose bleeding that happens often
  • menstrual or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stools (looks like tar)
  • bruises that happen without a known cause or that get larger
  • coughing up blood or blood clots
  • vomiting blood or vomit that looks like coffee grounds.

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