Pradaxa (generic name dabigatran) prevents blood clots via the protein thrombin, which has been shown in trials to prevent blood coalescing in patients who display a specific heart rhythm known as atrial fibrillation.
Approved in 2010, and administered in the form of capsules, Pradaxa reduces the likelihood of stroke, especially in the elderly. With more than 1.1 million prescriptions written since its licensing, Pradaxa looked like a winner, producing fewer side effects than warfarin, a Gen. 1 anticoagulant that once set the market standard.
At least that was the song and dance EU manufacturer Boehringer Ingelheim gave the U.S. Food and Drug Administration, or FDA, to garner approval for Pradaxa. The anti-coagulant, which one proponent called “warfarin 2.0”, was heralded as requiring less management and producing fewer side effects than warfarin, based on reports of patients and physicians who switched from warfarin to Pradaxa.
These side effects can include abdominal or stomach pain, bruising, minor bleeding, nausea, and symptoms that suggest indigestion and/or acid reflux or heartburn. Pradaxa has never been studied for use in pregnant women, and though common side effects are pretty generic, a few symptoms should send patients to their physician. These are:
- Black, tarry stools
- Bleeding that will not stop
- Blood in the urine as well as pink or brown urine
- Coughing up blood
- Easily bruised
- Heavy menses in women
- Joint pain or swelling; or
- Petechia, or purple/red pinpoint bloodspots under the skin
- Unexpected bleeding, from the nose, mouth, vagina or rectum
- Vomit that looks like coffee grounds
- Weakness, light-headedness, dizziness
If that’s not sufficiently alarming, let’s not forget those few but very disconcerting Pradaxa symptoms that should send patients directly to the ER:
- Difficulty breathing associated with anaphylactic shock
- Rash, itching and swelling – particularly of the face, tongue or throat
- Severe dizziness that prevents users from standing up
- Slurred speech
- Vision changes
- Weakness on one side of the body
The FDA has issued its own warnings vis-à-vis Pradaxa, most directed at the retirement-age crowd or older. The most serious – based on observation of its pre- and post-operative use – appears to be most prevalent in patients with mechanical heart valves; the drug has not yet been studied in patients with heart valves made from natural body tissues.
Boehringer Ingelheim, the manufacturer, has a less than stellar reputation even without its record on Pradaxa. Its sole plant in the U.S., in Ohio, is called Ben Venue Laboratories. This location was shut down in November of 2011 after FDA inspectors determined conditions were unsatisfactory for preparing pharmaceuticals.
Their findings? Rusting tools, a pervasive buildup of mold, and a barrel in which employees relieved themselves rather than trekking to the nearest bathroom. It was only after a $300 million investment to upgrade that the FDA gave Ben Venue its license back, but the lesson was evident. Ben Venue, which had a record of 40 recalls – nine of which were potentially deadly – was more interested in quantity than quality.
Perhaps even more important than its careless indifference is the fact that Boehringer Ingelheim stopped the phase II RE-ALIGN human trials, which were attempting to evaluate the benefits of Pradaxa in patients with mechanical valves. This cohort was more inclined to experience strokes, heart attacks and the formation of blood clots compared to those taking warfarin – a blood thinner which a Duke University cardiologist has cited as one of the leading causes of emergency room deaths in the U.S.
The positive press coverage generated by the company – $464 million, all told – also generated more than $1 billion in sales. The U.S. market for blood thinners is estimated at $10 billion a year. Pradaxa wants its share – or more than its share. It has also applied for European approval, hoping to gain the lion’s share of a huge EU market also driven by an aging population and an unquestioning dependency on the hundreds of pharmaceuticals developed after WW II, including affordable penicillin.
That romance now seems to be over, with more than 500 deaths revealing Pradaxa’s dark side. In some deaths, the harm was so egregious that survivors are filing a lawsuit. For many, it’s a last-ditch stand against yet another medicine that doesn’t quite live up to its billing.
Unfortunately, if consumers win the class-action lawsuit, and force the FDA to recall/suspend Pradaxa, all that Boehringer Ingelheim has to do is produce a generic version. Generics require no oversight, according to the U.S Supreme Court, thanks to their relationship to existing, name-brand drugs. This blanket approval is called “grandfathering”.
Cost is another drawback to Pradaxa’s use. A year’s worth of warfarin costs about $200. The same regimen of Pradaxa costs $3,000, which means the end of the romance is likely to be very expensive for Boehringer Ingelheim.