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.
Tuesday, October 28, 2014
Blood thinners and NSAIDs...The Increased Risk of Bleading
The risk of major bleeding is well documented while taking blood thinners such as: Warfarin; novel anti-coagulants such as Pradaxa, Xarelto and Eliquis; aspirin; and other NSAIDs such as advil and Motrin. One of the easiest ways to picture this is to think of you blood like this. If you spill a creamier salad dressing verses an Italian salad dressing, obviously, the bottle of Italian dressing will be empty before the bottle of the creamier dressing such as ranch is empty. When a person is on blood thinners, the person's blood is less viscous (less thick) compared to a person not on blood thinners.
There was a study conducted which was recently published in JAMA in June of 2014 which set out
"[t]o estimate the bleeding risk of combined anticoagulant (rivaroxaban or enoxaparin–vitamin K antagonist [VKA]) and NSAID or aspirin therapy in patients with venous thromboembolism." In plain english, that means to determine the risk of a major bleed like a stroke or stomach bleed while on these medicines or a combination of these medicines.
In a blog post linked to here, the lead author, Bruce L. Davidson, M.D., discusses the findings. Some of the major findings were that if people are taking anticoagulant medications such as Xarelto, Lovenox, or Warfarin, and are additionally taking an NSAID, they are 2.5 times as likely to suffer a major bleed than if they are just taking the anti-coagulant medication alone. The risk of taking aspirin together with an anticoagulant raised the risk of a major bleed by 1.5 times compared to taking the anticoagulant alone. Also, almost a quarter of the bleeds happened within 8 days of starting the NSAID.
Dr. Davidson is also quoted there saying that many people could take Tylenol instead of an NSAID for everyday aches and pains while on anticoagulant medications.
Major Public Health Implication: If people taking anticoagulant medications would be encouraged to take tylenol instead of NSAIDs for minor problems like colds and sore throats, many major bleeds could be prevented, lives saved, and many healthcare dollars saved.
There was a study conducted which was recently published in JAMA in June of 2014 which set out
"[t]o estimate the bleeding risk of combined anticoagulant (rivaroxaban or enoxaparin–vitamin K antagonist [VKA]) and NSAID or aspirin therapy in patients with venous thromboembolism." In plain english, that means to determine the risk of a major bleed like a stroke or stomach bleed while on these medicines or a combination of these medicines.
In a blog post linked to here, the lead author, Bruce L. Davidson, M.D., discusses the findings. Some of the major findings were that if people are taking anticoagulant medications such as Xarelto, Lovenox, or Warfarin, and are additionally taking an NSAID, they are 2.5 times as likely to suffer a major bleed than if they are just taking the anti-coagulant medication alone. The risk of taking aspirin together with an anticoagulant raised the risk of a major bleed by 1.5 times compared to taking the anticoagulant alone. Also, almost a quarter of the bleeds happened within 8 days of starting the NSAID.
Dr. Davidson is also quoted there saying that many people could take Tylenol instead of an NSAID for everyday aches and pains while on anticoagulant medications.
Major Public Health Implication: If people taking anticoagulant medications would be encouraged to take tylenol instead of NSAIDs for minor problems like colds and sore throats, many major bleeds could be prevented, lives saved, and many healthcare dollars saved.
Wednesday, October 1, 2014
Economic Burden of Blood Clots...Number$
Why are anticoagulant medicines so economically significant? Why are drug companies coming up with new so called novel anti-coagulants?
Because many people get treated every year in the U.S. for blood clots. And although the medicine to prevent blood clots them can be expensive, it is also very expensive to treat blood clots that already exist. And obviously, this is not even measuring the grievous human toll from sickness, disability and death caused by blood clots....and the heart attacks and strokes caused by them. Read a previous post here which discusses that toll. And read another website post here which discusses some of the risk factors and statistics related to blood clots.
In an April 2009 article published by the American Journal for Preventive Medicine linked to here, it is estimated that annually there are 300,000-600,000 new incidences of Venous thromboembolism (VTE) (colloquially referred to as blood clots). It is also estimated that the cost to the U.S. medical system at that time was ranges from $7594 to $16,644 per patient per incident. That translates to an annual cost at that time in the range of 2-10 billion USD.
Obviously, the more blood clots prevented results in savings in medical expenditures....oh, yeah...and it results in more people remaining healthier and alive.
Because many people get treated every year in the U.S. for blood clots. And although the medicine to prevent blood clots them can be expensive, it is also very expensive to treat blood clots that already exist. And obviously, this is not even measuring the grievous human toll from sickness, disability and death caused by blood clots....and the heart attacks and strokes caused by them. Read a previous post here which discusses that toll. And read another website post here which discusses some of the risk factors and statistics related to blood clots.
In an April 2009 article published by the American Journal for Preventive Medicine linked to here, it is estimated that annually there are 300,000-600,000 new incidences of Venous thromboembolism (VTE) (colloquially referred to as blood clots). It is also estimated that the cost to the U.S. medical system at that time was ranges from $7594 to $16,644 per patient per incident. That translates to an annual cost at that time in the range of 2-10 billion USD.
Obviously, the more blood clots prevented results in savings in medical expenditures....oh, yeah...and it results in more people remaining healthier and alive.
Tuesday, September 23, 2014
Strokes, and Blood Thinners: Some numbers, treatments, risks, and costs
About
795,000 suffer a stroke in the U.S. every
year. That is one person suffering a stroke every 40 seconds. Someone dies
every 4 minutes from the U.S. See this link here from the American Heart association and the American Heart Association.
Blood
clots can cause heart attacks and strokes. Strokes and heart attacks,
specifically in the elderly population, can cause severe debilitating long term
effects including paralysis and even death. Blood thinners have lowered the
risk of strokes and heart attacks and all of their debilitating side effects by reducing the formation of blood clots in the body. In order to reduce the risk of blood clots
for vulnerable patients (e.g. older people or people with a history of blood
clots), doctors prescribe anti-coagulant drugs. Anti-coagulant
drugs reduce the risk of blood clots that can lead to heart attacks and strokes
by decreasing the clotting ability of blood. However, as a necessary
consequence of reducing the clotting ability of blood, anti-coagulant drugs increase
the risk of excessive bleeding.
The leading anti-coagulant drug for decades was Warfarin, also known as Coumadin.
It works by inhibiting the production of vitamin K. The known antidote to stop bleeding
while on Warfarin is the injection of vitamin k.
Recently,
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.
Economically, Warfarin is
estimated to cost about $200 annually compared to Xarelto which can cost close
to $3,000 anually.
In 2013,
Pradaxa’s globals sales were about $1.63 billion USD. Xarelto’s sales were $271 million USD.
Eliquis’es sales were only $71 million USD but it only became available in the
middle of the year.
Many strokes are preventable. It is important to know your risk and weigh the cost and benefit of treatment. But it is also important to keep in mind the risk from the treatment.
I am short on time so I will continue this post later on....
Thursday, August 21, 2014
Low-t Controversy
Many people are inundated with ads asking them if they can benefit from testosterone therapy while many of those same people are also inundated with ads asking them if they have been harmed by androgel (or similar medications), a medicine commonly used therapeutically to raise the testosterone levels in people with low testosterone levels who meet certain criteria. So is low-t treatment beneficial or harmful?
Dr. Todd B. Nippoldt, M.D., A Mayo Clinic physician, wrote in an expert answers segment earlier this year which is linked to here responding to the question of what are the risks associated with testosterone therapy that some studies suggest that testosterone therapy may:
1.increase the risk of heart attack in men older than 65
2. increase the risk of heart attack in men younger than 65 with a history of heart disease
3.increase the frequency of death and heart problems in men who had coronary artery disease
Dr. Nippoldt also wrote, however, that other studies suggest a lower risk of death in men on testosterone therapy compared to men not being treated.
Dr. Nippoldt also pointed out that, "[c]urrently, the Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.'"
Just yesterday, Fox News published an article which is linked to here where physician Dr. David B. Samadi generally outlines main points about testosterone therapy and its risks and benefits. A very important idea he wrote was that "[s]tricter regulations and warnings by government agencies such as the FDA could prove extremely beneficial for men seeking this type of therapy. Often, testosterone is prescribed to men without proper blood testing, with no regulation or review of side effects or risks. This push towards regulation forces both patients and physicians to question whether the benefits of Low-T products outweigh potential risks of treatment."
Testosterone replacement therapy is also a big business. According to a November 11, 2013 article in the New York Times, linked to here, that physician recommendations and "and the marketing of low T as a common medical condition helped propel sales of testosterone gels, patches, injections and tablets to about $2 billion in the United States last year, according to IMS".
Bottom line: While Low-t treatment may be beneficial for a certain population, it may be dangerous for other populations. People should be careful that the benefit they can receive from low-t therapy outweighs the risks of the treatment.
Dr. Todd B. Nippoldt, M.D., A Mayo Clinic physician, wrote in an expert answers segment earlier this year which is linked to here responding to the question of what are the risks associated with testosterone therapy that some studies suggest that testosterone therapy may:
1.increase the risk of heart attack in men older than 65
2. increase the risk of heart attack in men younger than 65 with a history of heart disease
3.increase the frequency of death and heart problems in men who had coronary artery disease
Dr. Nippoldt also wrote, however, that other studies suggest a lower risk of death in men on testosterone therapy compared to men not being treated.
Dr. Nippoldt also pointed out that, "[c]urrently, the Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.'"
Just yesterday, Fox News published an article which is linked to here where physician Dr. David B. Samadi generally outlines main points about testosterone therapy and its risks and benefits. A very important idea he wrote was that "[s]tricter regulations and warnings by government agencies such as the FDA could prove extremely beneficial for men seeking this type of therapy. Often, testosterone is prescribed to men without proper blood testing, with no regulation or review of side effects or risks. This push towards regulation forces both patients and physicians to question whether the benefits of Low-T products outweigh potential risks of treatment."
Testosterone replacement therapy is also a big business. According to a November 11, 2013 article in the New York Times, linked to here, that physician recommendations and "and the marketing of low T as a common medical condition helped propel sales of testosterone gels, patches, injections and tablets to about $2 billion in the United States last year, according to IMS".
Bottom line: While Low-t treatment may be beneficial for a certain population, it may be dangerous for other populations. People should be careful that the benefit they can receive from low-t therapy outweighs the risks of the treatment.
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