A physician wrote up a case study here detailing the case of a 39 years old female in the Detroit area who had uncontrollable bleeding while on Xarelto. The physician contrasts the lack of a specific protocol to treat such bleeding as compared to a patient who presents with bleeding while on Warfarin/Coumandin. There is a very specific FDA protocol approved for people who bleed while on Warfarin.
In the end, physicians were forced to perform a surgery that affected the woman's fertility to save her life. They succeeded. The patient left the hospital alive....but most probably, she could have also left the hospital with her fertility if there were specific protocols to address bleeding while on Xarelto.
Wednesday, April 15, 2015
Wednesday, April 1, 2015
Xarelto and other anticoagulent drugs: Patients should be informed of Risks and Alternative Treatment Options
Physicians and patients always need to evaluate the relative risks of various treatment options in deciding on the best therapeutic treatment for a given condition.
As discussed in a previous blog post linked to here, the need for blood thinning medication is an essential tool in lowering the risk for developping blood clots which can lead to heart attack, stroke, and/or death in people with certain heart problems. In fact, someone dies from a stroke in the U.S. every 4 minutes. So the need for effective blood clot preventing medication is clear.
A person can choose to use Warfarin, the old fashioned blood thinner, or, in the last few years, the pharmaceutical industry has developed novel anti-coagulant drugs. Their scientific names are dabigatran, rivaraxaban, and apixaba Their trade names are Pradaxa, Xarelto and Eliquis.
One advantage of the novel anti-coagulants, as compared to Warfarin, is that there is a less severe risk of intracranial bleeding (AKA a brain hemorrhage). A serious disadvantage, however, is that there is (or was) no known specific antidote for bleeding caused by the novel anti-coagulants. The vitamin K method used to stop bleeding caused by Warfarin does not work for Pradaxa, Xarelto and Eliquis because those drugs do not work by inhibiting the production of vitamin K. Rather, they work by directly targeting an enzyme in the blood called Factor Xa, which stimulates the production of thrombin, another enzyme which promotes blood clot formation.
Physicians and pharmaceutical companies are now working on various antidote for these drugs so that when people are bleeding, there is a way to reverse the affects of the medicines.
So, the question is, is it ever proper to sell a drug when you don't yet have a way to quickly reverse the very serious side effects it is known to cause...which is bleeding? Is it proper to sell this drug when Warfarin is on the market and may be a little riskier in certain regards but can be reversed if a patient is bleeding? Should drug companies need to disclose that there is no known anecdote for a drug like Xarelto whereas there is for Warfarin, a drug which is used to treat the same condition? Should drug companies need to have an andectote availible before they market and sell the drug?
Again, these questions all depend on various different philosophies and core beliefs, but, it isn't unreasonable to assume that patients should at least be informed that there is no known anecdote to a drug like Xarelto, whereas, if they would take Warfarin, the effects of bleeding can quickly be reversed with the proper dosage of vitamin k.
As discussed in a previous blog post linked to here, the need for blood thinning medication is an essential tool in lowering the risk for developping blood clots which can lead to heart attack, stroke, and/or death in people with certain heart problems. In fact, someone dies from a stroke in the U.S. every 4 minutes. So the need for effective blood clot preventing medication is clear.
A person can choose to use Warfarin, the old fashioned blood thinner, or, in the last few years, the pharmaceutical industry has developed novel anti-coagulant drugs. Their scientific names are dabigatran, rivaraxaban, and apixaba Their trade names are Pradaxa, Xarelto and Eliquis.
One advantage of the novel anti-coagulants, as compared to Warfarin, is that there is a less severe risk of intracranial bleeding (AKA a brain hemorrhage). A serious disadvantage, however, is that there is (or was) no known specific antidote for bleeding caused by the novel anti-coagulants. The vitamin K method used to stop bleeding caused by Warfarin does not work for Pradaxa, Xarelto and Eliquis because those drugs do not work by inhibiting the production of vitamin K. Rather, they work by directly targeting an enzyme in the blood called Factor Xa, which stimulates the production of thrombin, another enzyme which promotes blood clot formation.
Physicians and pharmaceutical companies are now working on various antidote for these drugs so that when people are bleeding, there is a way to reverse the affects of the medicines.
So, the question is, is it ever proper to sell a drug when you don't yet have a way to quickly reverse the very serious side effects it is known to cause...which is bleeding? Is it proper to sell this drug when Warfarin is on the market and may be a little riskier in certain regards but can be reversed if a patient is bleeding? Should drug companies need to disclose that there is no known anecdote for a drug like Xarelto whereas there is for Warfarin, a drug which is used to treat the same condition? Should drug companies need to have an andectote availible before they market and sell the drug?
Again, these questions all depend on various different philosophies and core beliefs, but, it isn't unreasonable to assume that patients should at least be informed that there is no known anecdote to a drug like Xarelto, whereas, if they would take Warfarin, the effects of bleeding can quickly be reversed with the proper dosage of vitamin k.
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