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FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (febuxostat)

Uloric (Febuxostat) was FDA approved in 2009 as a means to treat Gout, a form of arthritis. The FDA has since concluded that there is an increased risk of heart-related death and death from all causes from Uloric and now requiring a boxed label warning.

The makers of Uloric (Febuxostat) are also recommending that health care professionals reserve prescribing it only to patients that have failed to achieve relief from Allopurinol or those that were unable to tolerate Allopurinol.

The makers of Uloric, Takeda Pharmaceuticals, were forced to include a “precaution” about possible cardiovascular events in patients at the time of release but has since been updated to the most prominent warning, a boxed warning. Sadly, Takeda Pharmaceuticals was able to manufacture and sell Uloric in the US without any complication warning on the drug’s label for years.

A safety trial was conducted to compare the risks posed by both Allopurinol and Uloric. 15 deaths from heart-related causes per 1,000 patients taking Uloric was observed over a year’s time compared to 11 deaths from heart-related causes per 1,000 treated with Allopurinol. Additionally, 26 deaths from any cause, per 1,000 patients, was observed with Uloric use over that year compared to 22 deaths per 1,000 from Allopurinol. This trial, known as the CARE trial, suggested that Uloric was connected to significantly higher risk for fatal cardiovascular events like heart attacks, strokes, and unstable anginas.

The FDA has been fully aware of these potential complications as early as 2009 and even attempted to minimize the heart problems that Uloric could cause by only approving 40mg and 80mg doses as opposed to the 80mg and 120mg doses that Takeda Pharmaceuticals had requested. Sadly, it took until 2018 for the FDA to require the box label warning based on the results of the postmarket trial that was conducted (CARES).

Uloric (Febuxostat) has also been linked to abnormal liver function. People taking Uloric were shown to have three times higher than normal levels of transaminase. While it remains unlcear as to whether Uloric directly heightens those levels, physicians who prescribe Uloric are supposed to conduct a baseline liver test panel prior to starting Uloric and then continue to monitor for any changes.

Uloric (Febuxostat) has also been linked to severe and potentially fatal allergic reactions. Stevens-Johnson syndrome being one of these observations. Approximately one in 10 people who develop this syndrome fall victim and die from the disease.

The deceptive and faulty marketing that has allowed for years of uninformed use regarding the risk of cardiovascular events has led to numerous lawsuits against Takeda Pharmaceuticals.

Learn More Uloric (Febuxostat)

Learn More About Other Prescription Drugs for Gout

A Careful and Healing Gout Diet

Is it OK to walk with gout?

Medical News Today: It is safe for people to walk with gout. In fact, doing joint friendly activities such as walking can help improve gout-related pain.

Gout is a form of arthritis that usually affects the big toe joint, but it can also affect the lesser toes, ankles, and knees. It normally affects one joint at a time.

People with gout may find it difficult to carry out physical activity, or they may be worried that physical activity will make their gout worse.

This article will examine whether or not it is safe to walk with gout. It will also cover how to manage, treat, and prevent this condition.

Hyperuricemia as a potential plausible risk factor for periodontitis

Abstract

Author: Zi-yun Chen,Lu-wen Ye,Li Zhao,Zhao-jia Liang,Ting Yu,Jie Gao

Publication: Medical Hypotheses

Publisher: Elsevier

Date: April 2020

Elevated blood uric acid (UA) levels have been positively associated with the severity of periodontitis. It thus brings out a hypothesis that hyperuricemia, a pathological elevation of blood UA, might be a risk factor for periodontitis. Namely, periodontitis individuals with Hu might acquire more severe periodontal destruction compared to those without Hu. To support the hypothesis, four aspects of evidences are proposed.

In-hospital cardiac procedures up for those with gout, rheumatoid arthritis

(HealthDay)—Rates of in-hospital cardiac procedures continued to increase in people with gout and rheumatoid arthritis (RA) from 1998 to 2014, although they decreased for the general population, according to a study published online Feb. 25 in Therapeutic Advances in Musculoskeletal Disease.Jasvinder A. Singh, M.B.B.S., M.P.H., and John Cleveland, M.D., both from the University of Alabama at Birmingham, used data from the U.S. National Inpatient Sample (1998 to 2014) to examine the frequency of seven common cardiac and orthopedic procedures in hospitalized people with gout and RA compared to the general population.

Gout ‘more than doubles’ risk of kidney failure

Largest ever study on subject uses data from more than 620,000 patients in UK health system

Date: August 28, 2019
Source:University of Limerick
Summary: Patients with gout are at increased risk of chronic kidney disease and kidney failure, according to new research.

Patients with gout are at increased risk of chronic kidney disease and kidney failure, according to new University of Limerick (UL), Ireland led research.

In one of the largest and most detailed studies ever conducted, patients recruited in general practice with a diagnosis of gout were more than twice as likely to develop kidney failure than those without, according to the study led by researchers at University of Limerick’s (UL) Graduate Entry Medical School (GEMS).

Wearable sweat sensor detects gout-causing compounds

Date:November 25, 2019

Source: California Institute of Technology

Summary: Scientists have developed an easier way to mass-produce highly sensitive sweat sensors that can detect a variety of low-concentration compounds related to health conditions.

There are numerous things to dislike about going to the doctor: Paying a copay, sitting in the waiting room, out-of-date magazines, sick people coughing without covering their mouths. For many, though, the worst thing about a doctor’s visit is getting stuck with a needle. Blood tests are a tried-and-true way of evaluating what is going on with your body, but the discomfort is unavoidable. Or maybe not, say Caltech scientists.

Gout Questions and Answers

Let us better help you better understand this condition – despite the tons of misinformation that circulates on the internet.

Why are blood test results misleading when it comes to a Gout diagnosis?

Blood tests can reveal the concentration of uric acid in your system. However, while you are under an attack your blood could potentially read quite normal. Over 60% of patients presenting with acute gouty arthritis symptoms have uric acid levels of <8mg/dl. Measuring serum uric acid levels while under an attack may not be too helpful in a diagnostic sense. Why? The crystals relentlessly jabbing at your joints are NOT in a soluble form at that time.

Gobble, Gobble- Important tips regarding Gout and Holiday Meals

It was Thanksgiving of 2014 and our family had just concluded another successful gathering full of feasting and festivities. I recall feeling a bit stressed about all the food I had just consumed; food I knew I could, and likely would, pay for later. When you have Gout that dreaded scenario is likely always weighing on you in the back of your mind. WHAT did I just do to myself?

Is there any chance I could dodge a bullet this time?

What can I possibly do to get ahead of this game?

Maybe if just consume a ton of water, and water only, can I avoid the inevitable?

Was that turkey and gravy, and pie, and, and, and….all worth it?

As Gout sufferers we are all fully aware of the risks involved and sometimes we choose to face those risks head on, despite the potential outcome. I remember wondering then if there were measures to take ahead of time to avoid the worry of a splurge here and there. I was young and dumb, and rather clueless about the sheer number of things I did and consumed on a daily basis that kept adding to my demise. Understanding the necessity of balance was never my strong suit.

…..Fast forward to the middle of the night, post thankful feasting, and I am awakened by a pain in my ankle that I knew all too well; the kind of pain worthy of wishing to lose a limb rather than continue the suffering. Said ankle was red hot, swollen and throbbing in pain. Agony was an understatement and black Friday took on a whole new meaning. There would be no shopping, no leftover turkey stuffing sandwiches, nothing resembling anything remotely close to my ability to leave that bed.

I.WAS.MISERABLE. WHY had I done this to myself, again?? I knew better. I began swallowing Colchicine like candy. Que the digestive disaster in the making. Now, I’m sick as a dog AND in pure agony. Ice, heat, water, Ibuprofen, repeat.

Sound familiar?

That attack was one of the absolute worst to date. It continued to move around to different areas of my body and was categorically relentless. I vowed from that day forward that I was going to avoid ever suffering like that again. A wise man told me that I needed to start looking at this Gout puzzle with more clarity and understanding. He told me that we tend to be very narrow-minded in our approach and limited in thinking that one meal could cause an attack when food purines are such a miniscule piece of this puzzle. What was I doing each and every day to contribute to my “glass of uric acid” until that one meal causes it to spill over into an attack? What could I do to lower that full glass to a point where a splurge wouldn’t push me over that edge?

Some important things I’ve learned:

You may have ‘trigger foods’ that spark an attack. A purine-rich meal may push your ‘already full’ glass over the edge and into an attack. However, be sure to understand things were already brewing and these triggers simply tipped the scale.

SOLUBLE uric acid can be measured in your blood supply. However, the uric acid that has crystallized and is now residing in connective tissue cannot be measured with a blood analysis. These crystals are always there, in a solid form, “melting” when the levels in the blood will allow and adding to the buildup when levels in the blood become too high for the blood to carry. These deposits are what migrate into the joint causing the acute gout attack. When the tissue is full, any food indulgences and lifestyle choices that cause you to produce more uric acid than the blood can hold, will allow for deposits that crystallize between the bone joints. This can make you falsely blame one food for triggering your attack when in all actuality it simply “tipped the already full cup over.”

Cellular regeneration is the only way to achieve Gout control success. Food, water, spices, vitamins, herbs, and therapeutic actions (meditation, exercise, listening to music) can significantly elevate the body’s regenerative process. Together they, and you, can take control of your health and begin repair. While some parts will remain permanently damaged, there are many areas where an overhaul can bring you the quality of life you have been missing.

Why Does Gout Attack at Night?

Why Do Low-Purine Diets Fail?

Important tips regarding Gout and other Inflammatory Conditions

Is there a relation of temperature and humidity to the risk of Gout attacks?

The shear number of variables involved with recurrent Gout attacks is nothing short of overwhelming. The search can have you running in 50 different directions to try and determine what triggered the attack. What food did I eat? Did I drink enough water? Could it be my medication? Did I hurt myself? Am I too stressed out right now? The list goes on and on. How about the weather? Does the weather factor into the risk? Evidently, it does, and there are studies to prove it.

Boston University School of Medicine conducted a study to test the suspected effects of humidity and temperature on the changes of recurrent gout attacks. This took place over a two-day control period noting temperature, barometric pressure, humidity, and precipitation for each person’s zip code. Adjustments were made for alcohol consumption, purine intake, and diuretic use. The study linked volume depletion, or extracellular fluid volume contraction (ECF) to the risk of recurrent Gout attacks. High temperatures and extreme degrees of humidity, in both directions, were associated with higher risk of gout attacks. High ambient temperature and low humidity yields the greatest association by some 40% compared with moderate temperature and relative humidity. “Our data indicate that both high temperature and high humidity are associated with an increased risk of recurrent gout attacks,” explains Yuquing Zhang, D.Sc., Professor of Medicine and Epidemiology, Boston University School of Medicine; Boston, Massachusetts and an investigator in the study. “Thus, when it’s hot and humid, those with gout should consider drinking more fluids to avoid potentially painful gout attacks.”

Even though there is a proclivity for the distal joints to be affected more due to colder temperatures, the study did not seem to show any correlation between colder weather and higher risk of an attack. Volume depletion, not to be confused with dehydration, and metabolic acidosis are driving forces behind a decrease in uric acid excretion and an increase in uric acid production. Acidosis also affects uric acid solubility allowing for crystal formation. The distal joints tend to carry a lower blood pH making them more susceptible to uric acid crystallization.

High humidity disrupts the body’s ability to regulate its temperature. The evaporative cooling process related to sweating becomes less effective and, in turn, causes the body temperature to rise and perspire in an attempt to cool. The combination of high temperatures and high humidity naturally increase the risk for dehydration. Our beverage selection in this circumstance is crucial. Some may replace this loss with water, but some tend to grab a sugary or beer related option, wreaking even more havoc on the attempts to remain gout attack free. Many do not realize that low humidity can also lead to dehydration by way of increased evaporation from the skin and mucous membranes. This poses an even greater risk due to the fact that it may “feel” cooler further keeping us from replacing this loss by drinking more water as it would require. Think about this when it comes to flying on an airplane. Despite the temperature feeling comfortable, the cabin tends to be very dry. Many experience attacks during travel, and this happens to be one of a many components that add to that risk.

In conclusion, it has been determined that both high temperature and the extremes of humidity are associated with an increased risk of recurrent gout attacks. Under such weather conditions, people with gout should aim to increase fluid intake to replace volume depletion.

Avoiding Gout while traveling

Why does Gout attack mostly at night?

Gout and Higher Risk of Death

Gout Diet: Are Impossible Burgers/Foods Impossible To Be Good For You?

We seem to have found ourselves at yet another set of crossroads regarding conflicting ideas when it comes to lab-grown foods such as the Impossible Burger. It may be easy to assume ‘plant-based’ diets are healthy, but are they? We know that highly processed foods are unhealthy and unfortunately this new fad of plant-based foods are exactly that, highly processed.

Continue reading “Gout Diet: Are Impossible Burgers/Foods Impossible To Be Good For You?”

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