One of my patients called the office today concerned about a medication she was taking because she was “seeing about 4-5 commercials a day about how bad Xarelto is”.
She is the latest of many of my patients who have been inundated with ads like these which state in very strident tones that a drug is bad and that if “you or a loved one has had a serious bleeding problem” contact 1-800-BAD DRUG and see if you are eligible for compensation.
These drugs are not bad and the only reason these advertisements are being played is that tort lawyers sense an opportunity to make money.
To understand why they are flooding the TV market now I will have to give you some background on atrial fibrillation , stroke and the drugs available to reduce stroke risk.
Preventing Stroke Associated With Atrial Fibrillation
Patients with atrial fibrillation are at increased risk of stroke and since the 1950s the only drug available for doctors to reduce clot formation in the heart and susbsequent strokes was warfarin (brand name Coumadin). Warfarin is only effective and safe within a narrow window and its effects are strongly influenced by Vitamin K in the diet and most medications. Thus, frequent blood testing is needed, and close monitoring of diet and changes in medications. Even with this close monitoring, serious and sometimes fatal bleeding occurs frequently with warfarin.
In recent years, three new drugs for reducing strokes in patients with atrial fibrillation which are much less influenced by diet and medications have gained approval from the FDA. These are generally referred to as “novel anticoagulants” reflecting their newness, different effects from warfarin or aspirin, and their blood thinning properties. The first (brand name Pradaxa) was released to much excitement and fanfare in October, 2010. The press release for this approval read as follows:
PRADAXA, an oral direct thrombin inhibitor2 that was discovered and developed by Boehringer Ingelheim, is the first new oral anticoagulant approved in the U.S. in more than 50 years. As demonstrated in the RE-LY® trial, PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily significantly reduced both ischemic and hemorrhagic strokes compared to warfarin
Differences Between Warfarin and the Novel Anticoagulants
What was very clear from the study with Pradaxa and stated very clearly in all publications and patient and doctor information sources was that just like warfarin, patients could have severe bleeding complications, sometimes fatal. Overall serious bleeding complications were about the same (the rate of major bleeding in patients Pradaxa in the RE-LY trial was 3.1% versus 3.4% in the warfarin group) but Pradaxa had about 50% more bleeding from the gastrointestinal tract and warfarin about 50% more bleeding into the brain.
Another big difference between the novel anticoagulants and warfarin is that we have antidotes (Vitamin K, fresh frozen plasma) that can reverse the anticoagulation state rapidly for warfarin but none for the newer drugs. This information also was made very clear to all doctors prescribing the medications in the package insert and educational talks. Despite this, in the major trials comparing these newer agents to warfarin, the newer agents were as safe or safer than warfarin.
The Pradaxa Bad Drug Ads
Beginning about a year after Pradaxa was released advertisements paid for by law firms seeking “victims” of Pradaxa identical to the ones we are now seeing for Xarelto began to appear.
The Pradaxa ads went away in mid 2014 when these lawsuits were settled and almost immediately the lawyers began paying for Xarelto ads. Xarelto was the second “novel anticoagulant) to be approved by the FDA and, similar to Pradaxa, was proven to as effective as warfarin in preventing strokes with a similar rate of serious bleeding complications.
As the Wall Street Journal noted (with the catchy title “The Clot Thickens” and opening line “Is a blood thinner causing lawyers to smell blood?”)
“Spending (on Xarelto ads) jumped to $1.2 million in July from just $8,000 in June, according to The Silverstein Group Mass Tort Ad Watch, which noted the number of ads that ran in July exceeded 1,800. …
The spending increased shortly after Boehringer Ingelheim, which sells a rival blood thinner called Pradaxa, last May agreed to pay $650 million to settle about 4,000 lawsuits over claims the drug caused serious bleeding episodes. The settlement likely emboldened attorneys to turn their sights toward Xarelto which, like Pradaxa, is one of a relatively new batch of blood thinners.”
The third drug to be approved for preventing strokes in atrial fibrillation was Eliquis. Data from the large, randomized study comparing it to warfarin suggest that it is more effective at preventing stroke than warfarin and significantly less likely to have bleeding complications. However, I predict that within the year (especially if the Xarelto lawsuits also are settled by its manufacturer) we will start to see lots of TV ads telling us that Eliquis is a BAD DRUG.
It’s important to remember that all drugs have benefits and side effects. Seemingly harmless antibiotics can increase your risk of dying suddenly (see here), rupturing your achilles tendon or developing a life-threatening colitis.
Xarelto is not a BAD DRUG. When prescribed to appropriate patients with atrial fibrillation with appropriate precautions it prevents strokes which are potentially life-threatening or disabling. All blood thinners are two-edged swords: they stop good clots and bad clots.
Ignore The Ads
Patients are better off ignoring both positive, direct to consumer, advertisements, promoting these newer anticoagulants and negative, greedy-lawyer sponsored advertisements, soliciting “victims”.
Hopefully when your doctor discusses the choices of blood thinners with you he will present to you a balanced discussion of the pros and cons both of whether or not to take a blood thinner and whether to take the old standby warfarin or one of the newer agents. An interactive discussion should follow in which your particular issues and concerns factor into the final decision.
13 thoughts on “Why Does The TV Tell Me Xarelto is a BAD DRUG?”
The Skeptical Cardiologist should educate himself on the effects of Xeralto with a patient that has a blood condition that produces amyloidosis proteins in the blood. The combination spelled brain bleeding stroke for me. Neither I nor my doctor understood such risks. I am paying for this inadequate knowledge.
Cerebral amyloid angiopathy is commonly found in the elderly and affects the small vessels by the accumulation of amyloid beta-peptides in cortical and leptomeningeal vessel walls.15 The accumulation causes weakening of vessel walls resulting in hemorrhage or infarction.16-18 and is also an important cause of cognitive impairment through ischemic and hemorrhagic mechanisms.19,20 Cerebral microbleeds (CMB) are commonly found in lobar white and gray matter in patients with CAA. Longitudinal studies show that the risk of recurrent ICH in patients with CAA is increased with higher number of microbleeds making CMB an important risk predictor in this context.21 A definite diagnosis of CAA can only be made upon postmortem examination, but guidelines for diagnosis of CAA in the living are established in the modified Boston Criteria. ch define Probable CAA is defined as the presence of multiple hemorrhages restricted to the cortical or cortico-subcortical regions or a single lobar cortical or cortico-subcortical hemorrhage with either lobar microbleeds and/or disseminated superficial siderosis as detected by CT or MRI in patients ≥ 55 years.22-24
Looks like CAA can happen with warfarin or any of the newer anticoagulants and can’t be diagnosed before the drugs are given.
Thank-you for mentioning amyloidosis and touching upon some of its disconcerting properties. Yes, by available means, I have this disorder as well as other members of my family. Had I known this I might have spared a stroke event. At present doctors all advise no blood thinners ever. As for the risk of stroke due to afib I take no blood thinners. And do not intend to partake of the Watchman. If you have any further wisdom on this subject please feel free to express it. It is a rare disorder and patients need to know the risks.
You bet! I appreciate giving me the heads up on it. I haven’t encountered it this cerebral localized amyloid (seems like it is not possible to diagnose easily) but recently encountered a patient who has had an unexplained spontaneous intracerebral bleed and will be considering whether he might have it.
All good to know. After a complete fail on warfarin, I am on Xarelto for life to prevent more pulmonary embolisms.
My Cardiologist explained all 4 of the new oral anticoagulants to me and we decided that Pradaxa was the best option for me. My Cardiologist explained tha pradaxa is the only one of the new oral anticoagulants that is superior to warfarin for preventing schemic strokes and it is also the only one of the new to have a reversal agent. My Cardiologist explained the risk of higher GI bleed for Pradaxa. He also said that pradaxa reduced the inter cranial hemorrhage by 50% over warfarin and that at the end of the day, inter cranial hemorrhage is the side effect he dreads the most. My cardiologist basically said to me that based on the fact that my condition puts me at a higher risk for stroke we decided to go with the only agent superior for preventing schemic strokes and that has a reversal. Being a retired lawyer myself, I understand fully well the tactics used in my practice. I am glad I had options that are unequivocally better than warfarin.
The article states above that fresh frozen plasma and Vitamin K reverses warfarin rapidly….that is wrong Vitamin K takes about 12 – 18 hours to work and FFB is very expensive will not work rapidly. Warfarin will increase ICH by 50% compared to the novel orals.
Thanks for your comments.
Vitamin K does take a while to reverse warfarin (intravenously given, 8-12 hours) but fresh frozen plasma works immediately. (http://circ.ahajournals.org/content/125/23/2944/T1.expansion.html)
There is a higher rate of intracranial hemorrhage for warfarin and a higher rate of GI hemorrhage for Xarelto and Pradaxa.
Damn auto correct! Well said!
While I’m not a fan of any TV drug ads, at least the drug company ads are regulated by the FDA. I don’t understand why the lawyer ads aren’t also regulated by the FDA. After all they are making a claim about a drug (even if only “drug X is BAD”). How is it they get away with making unsubstantiated claims about a drug?
They don’t. They drug companies simply settle claims with the money they have set aside in their products’ budget. The drug companies know they will get sued because they know their drugs can and will cause serious side effects…they don’t care. They will make a ton of money from these dangerous drugs even after paying for all the lawsuits.