Are storm clouds already gathering over Pradaxa?Critics of blood-thinner drug troubled by events in New Zealand

(Oct. 18, 2011) If some safety advocates are correct, a drug worth keeping a skeptical eye on is the blood thinner Pradaxa because of its propensity to increase the risk of bleeding – perhaps fatally so, according to the manufacturer’s own label warning.

Already, in New Zealand, Pradaxa is tied to at least two deaths amid reports that scores of elderly users there experienced bleeding ranging from mild to severe.

Pradaxa – manufactured by Boehringer Ingelheim Pharma – is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Market observers believe Pradaxa could eventually overtake Coumadin (warfarin) as the therapy of choice among physicians.

Rush-to-market suspected

The problems in New Zealand resulted when patients at elevated risk for internal bleeding were given Pradaxa.

As of last month, New Zealand’s Centre for Adverse Reactions Monitoring reported 50 incidents involving Pradaxa and internal bleeding. Discontinuing Pradaxa intake ended the bleeding for many of the affected patients, although some nonetheless required medical intervention, including transfusions.

Critics allude that Pradaxa has not been adequately studied. They contend the gap in knowledge about its full effects is the result of efforts to hurry the drug to market ahead of at least two others – one of which is said to have the potential to dominate the arena. These observers theorize that the manufacturer hoped to quickly convince as many physicians as possible to develop a prescription-writing preference for Praxada before Eliquis from Pfizer and Bristol-Myers Squibb and Xarelto from Bayer and Johnson & Johnson could enter the competition for market share.

(Of the two, Eliquis is thought likely to be the stronger market performer, if clinical trial results and the investment community’s favorable reaction to that study are any indicator.)

Pradaxa, however, does have its defenders. In their view, Pradaxa owns a better safety profile than Coumadin. For example, a 2009 New England Journal of Medicine study found that a 150-mg dose of Praxada was associated with lower rates of stroke and systemic embolism than warfarin – although both products at that dose had similar rates of major hemorrhage. Further, the journal reported that the two at lower doses were similar with regard to stroke and systemic embolism risks, but observed that Praxada in reduced strength had lower rates of major hemorrhage.

Latest News from Pharma-Watch

FDA convenes to determine Fosamax bone fracture dangers

The New York Times Reports: In light of evidence linking the long-term use of Fosamax and femur fractures, the FDA said it plans to convene Friday to determine whether it will recommend suspending the use of the osteoporosis drug.

Spine Specialists Discredit Medtronic Bone Growth Product

June 29th, 2011 “It harms patients to have biased and corrupted research published…It harms patients to have unaccountable special interests permeate medical research,” read an excerpt from an

CT Brain Perfusion Scan Risks

The FDA released an advisory to consumers in October regarding the CT Bran Profusion Scan manufactured by GE. The advisory states that the scans default radiation therapy is set to high for most patient

Risk of death found in sleeping pill use -- Scripps

Scripps Study: Sleeping pills believed a cause of 500,000 premature deaths annually (March 1, 2012) Pick 10 people at random and ask them if they take sleeping pills. Chances are at least one of them

FDA pulls approval of Avastin breast cancer drug

Avastin no longer allowed for breast cancer The U.S. Food & Drug Administration has revoked its approval of Avastin after concluding the metastatic breast cancer treatment did nothing to control tumor