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The recent withdrawals of the prescription medications Vioxx and Bextra from the marketplace have many people concerned. Studies show that the use of Vioxx could increase the likelihood of strokes and heart attacks; Bextra carries those same risks and also increases the chances of contracting Stevens-Johnson Syndrome, a potentially fatal skin disease. Frequently prescribed to minimize the inflammation and pain of arthritis, these prescription drugs belong to a family of non-steroidal anti-inflammatory drugs known as COX-2 inhibitors.

COX-2 inhibitors are a relatively recent breakthrough in medicine; they interfere with the COX-2 enzyme, which causes pain and inflammation, without interfering with COX-1, which protects the stomach lining.. Previous anti-inflammatory drugs eased the symptoms, but also interfered with COX-1, leaving many patients suffering from gastric discomfort.

While everyone who has been taking either Vioxx or Bextra would be well advised to see their doctor immediately, they might also wish to consider whether or not they should seek an attorney. While most people who have been taking these drugs have not suffered from adverse effects, anyone who has suffered from a heart attack, stroke, or other unusual symptoms while taking these medications may have grounds for a lawsuit. People who believe that they have been harmed by their use of Vioxx have already filed numerous lawsuits; similar suits involving Bextra are now being prepared. These suits are generally brought forth by attorneys who are experienced in drug litigation. A meeting with such an attorney, along with information from your physician, can probably help determine whether or not a prescribed COX-2 inhibitor may have harmed you. He or she can also advise you as to whether it would be in your best interest to either file a lawsuit or participate in a class-action suit, in which you and a number of other people with similar claims would file a suit as a group.

Have you ever taken the drug Vioxx or celebrex? In September 2004 the drug manufacturer Merck decided to recall the product after long term data suggested a serious potential side effect.

This drug and others like it such as as ‘Celebrex’, ‘Bextra’ and ‘Arcoxia’ are part of a family of drugs known as “COX2 drugs” or “COX2 inhibitors”

They have been developed with, ironically, patient safety in mind.They are typically used in treatment of arthritis, though high dose vioxx was promoted for short term relief of acute muscular/skeletal pains.They were anti-inflammatory drugs.

The serious side effects were in connection with the heart suggesting risk of heart disease or heart attack.In medical circles it was referred to as “..adverse cardiovascular effects.”

There are other drugs used to treat inflammation that have been around for many years.YOu may have heard of products such as Advil or Nurofen which contain the ingredient Ibuprofen.Other older anti-inflammatory drugs include such brands as Voltarol or Naprosyn.

What’s the difference between these older drugs and the recent treatments know as “COX2 drugs”?

The newer drugs such as Arcoxia,Celebrex and Vioxx were designed to be much more specific in their mode action than old drugs like Ibuprofen.The idea was to limit the associated problems in long term treatment.

When we get older we all seem to get more sensitive to side effects of drugs.Often this is complicated even more by the fact that we may suffer from more than one problem or disease at the same time.

At this point we take more medication in the last five to ten years of our lives than in all the other years put together! Is it any wonder we might feel under the weather, a little off colour even?

You could have asthma and high blood pressure. Anxiety and lack of sleep every night. Panic attacks and depression.

If you take an anti-inflammatory drug for a given length of time, your doctor/physician will no doubt tell you about one major problem.

Ulceration of the stomach or intestines…..

It was hoped that the newer COX2 drugs would not cause this problem at all.Therefore it would avoid the risk of someone suffering internal bleeding which could become fatal.

The older you become the greater the risk of this occuring. It could be a slow blood loss or a sudden episode of an ulcer bleeding more profusely.

So when people got the signs of ulcers, they got treatment for an ulcer. Some would stop taking medication and others would take a maintenance dose to prevent ulcers coming back while continuing to take the old ibuprofen drugs for their arthritis.

It was hoped drugs like vioxx would stop this, but ulceration still remains a possibility. Doctors routinely consider offering anti ulcer drugs to reduce the probability of this happening.

So what is the all the recent fuss about ? Where did it all suddenly seem to unravel after all that hope and expectation ? A new long term study seemed to indicate some degree of risk to the heart some 18 months or so after starting treatment.

So if you took vioxx for a week or a couple of months, this potential problem did not appear.It has only been spotted after taking the medication for a longer period such as 18 months.

What can you do? Are there ways to reduce risks? This is something you need advice on as only your doctor will have your medical history.There is much to consider and such a problem can in some circumstances be minimised.

Of course if you smoke you increase the risk of stomach or intestinal ulceration if you also take anti-inflammatory drugs such as Ibuprofen.Why not quit instead?

If you take other medication for depression or anxiety then these drugs can increase the risk of bleeding with any anti-inflammatory drug being taken at the same time.

Related Blogs

The news has been full of the recent FDA findings on a new set of drugs to help relieve pain. These drugs have been approved for re-release, but it is unclear whether Vioxx will be available again and whether physicians will feel comfortable prescribing Celebrex and Bextra for many of their patients.

What happened to Celebrex and Vioxx?

Celebrex, Vioxx, and Bextra are all non-steroidal anti-inflammatory drugs (NSAIDs, pronounced en-said-z), similar to drugs like ibuprofen and naproxen, that are available over the counter (OTC). Celebrex, Vioxx and Bextra, (sometimes called Cox-2 inhibitors) however, use a slightly different method to achieve the same effect as their OTC cousins; this new method was supposed to limit the side effects some people experience on OTC drugs, including stomach and intestinal problems and allergic reactions. It was thought that because these drugs were less likely to cause such problems, they might be safer for patients with painful chronic conditions (like arthritis) to use for long periods of time.

Unfortunately, some studies of Cox-2 inhibitors suggest that while they don’t cause the sorts of side effects of other NSAIDs, they may create a greater risk of myocardial infarction (heart attack) or stroke. For people already at risk for these diseases (including those who have already experienced a stroke or heart problem), taking these drugs over the long run may significantly increase the risk of heart problems.

Now What Can I Do To Get Pain Relief?

Until a final decision has been made on each of these drugs, what can your healthcare provider do to help you with pain management? Here are important pieces of information to think about in determining what next steps to take:

* The Cox-2 inhibitors were not shown to be more effective than other NSAIDs, like naproxen. If you’ve been on or thinking about trying Vioxx or another Cox-2 inhibitor, you may be able to use an older anti-inflammatory drug. Naproxen, one of the older NSAIDs, may be an anti-inflammatory drug that actually lowers heart attack risk.

* Some people started on a Cox-2 inhibitors because they had a stomach ulcer or other risk factors for stomach or intestine bleeding (for example, people on blood thinners), which may be made worse by older anti-inflammatory drugs. For some people who are at risk for bleeding, other options like acetaminophen may be an option.

* There are lots of other medical options. Steroids can be used for shorter periods of time to manage inflammatory pain from diseases like arthritis and lupus. Opioids (drugs that resemble opium), such as oxycodone, codeine, and hydrocodone (Vicodin) can help with pain management, but they can have serious side effects, and some of them can be addictive, so working closely with your healthcare worker is key to determine if these will work for you. In addition, some antidepressants may help with chronic (long-term) pain, though the way this works isn’t yet known

* New procedures may be of assistance to you. Nerve block therapy (in which certain nerves are temporarily anaesthetized) can relieve pain temporarily. “Implantable “technologies, like spinal cord stimulation (SCS) systems and implantable drug delivery systems, do seem to help some people for whom other pain relief methods don’t work.

* If you aren’t getting the relief you need (with or without the use of Cox-2 inhibitors), you may want to consult a pain specialist. Some large hospitals (such as Stanford University) have departments devoted to pain management. The American Board of Pain Medicine and the PainConnection (at painconnection.org) can help you locate a pain specialist who can work with your other healthcare professionals to put a new treatment plan together for you.

With the hum of the election campaign and the debate of “big business,” versus human interest, I decided to do a bit of muckraking into the art and science of the recent removal of Merck’s Vioxx. My motivation of course; to look for clues as to the role drug companies play in our health and wellness (or lack thereof).

Here’s some symptoms giving me trouble:

Symptom #1: After pulling Vioxx from the shelves, drug company, Merck, (as well as the media) made the “only 7.5 in 1,000 patients could be at risk for heart attack or stroke” sound like a simple omission.

Symptom #2: Prior to the pharmaceutical companies and pharmacies clearing their shelves of Vioxx, studies had shown the drugs destructive effects for over four years

Symptom #3: We are given all of this data in a most nonchalant fashion, prior to learning the amount of money Merck was pocketing on the drug: current tally, $2.6 billion (reference article above).

Symptom: #4: We are meant to be comforted by the fact that the drug, Vioxx, was released with only limited clinical testing. And gosh, if no one from the random sample had any cardiovascular consideration to begin with, who knew it would cause heart attacks or stroke ?

Symptom: #5: (Even if we are to digest this) Perhaps they shouldn’t have told us that in 2002, according to a report from the Blue Cross and Blue Shield Association ( www.bcbs.com ) over $160 million dollars was spent to advertise Vioxx (which was higher than advertisement dollars for both Pepsi and Nike).

Shall I continue?

Why not… here’s more off the cuff musings:

On the other side of the coin, Merck has set off a chain reaction. Each and every day I see advertisements from lawyers on my local upstate New York television asking for Vioxx users to step forward. Yes, if you dial 1-800 they’re at your disposal, poised and ready to sue the pants off Merck.

And so I ask you… Do two wrongs make a right?

Here’s my assessment of the situation based on clinical experience: When we’re sick, we trust our doctor to help us come back to health. We trust the pharmaceutical companies to support research and create drugs to prevent disease and ailments. Yet, in a fear based society (assuming death to be the fear we speak of) we hear precious little about the trust we should place on our bodies own natural ability to heal itself. It’s just that simple.

Let’s all be honest with each other, drug companies are betting that you are going to get sick ? and if and when you do they will be happy to accommodate you. When doctors prescribe drugs, pharmaceutical companies make money. And when a doctor prescribes a certain “brand” of drug, the doctor receives a kick-back from the company. It’s simple supply and demand.

What’s more, now their digging a little deeper into your pocket and your psyche. Here’s a prime example. Turn on your television set during ? let’s say football season just to be timely. You’ll notice prime?time advertisements by your favorite (or not so favorite) celebrities promoting Celebrex, Levitra and so on… These advertisements bypass the medical profession placing drugs on the table for commercial consumption.

So this all begs the question - are drugs bad for you? The answer can be both yes and no. All drugs have side effects. Most drugs are created from organic sources but are then chemically manipulated to cause a favorable reaction in the body. When you take a drug, basically, you’re putting an inorganic substance into nature.

Therefore, the hullabaloo makes me think ? how do we stay out of the machine? Or better yet, if there are drugs which will help people become well (which I believe there are) how do we keep the money-hungry honest? Here’s my 5 remedies:

Remedy One: Educate Yourself

What drugs can do is be a means to wellness. But you need to know the facts. If you walk into your doctor’s office with a list of symptoms, you will receive a drug that promises to (on paper) relieve you of your symptoms.

But what if those symptoms are trying to tell you something? And what if the drug your doctor prescribes could make you sicker? Here’s what you can do: If you are given a drug, check out the side effects and interactions here, then decide:

Remedy Two: Think Complimentary Medicine

So, Laura, what is complimentary medicine? Complimentary medicine asks you to take a long look at yourself, your body and your beliefs about why an illness has developed. It’s not about treating one ailment (joint pain, an injury, an illness) ? it’s about looking at the whole picture: your posture, your diet, your lifestyle. Then, creating an exit strategy for your illness.

Complimentary medicine asks you to take a look at your relationship to the affliction and then ? with your doctor’s facilitation - developing a treatment program as a means to health (which can include medication). This way you become fully active in your illness and treatment.

Remedy Three: Practice Prevention

The best way to approach wellness is when you are well. Then, if the time should come for you to become a part of your own health care, you can be honest with yourself and how you feel about your body.

Start now. Take a long look at your self. Begin by checking your score on the wheel of life:  Are you taking ample time for yourself? Time for exercise, time for play? Are there outside forces instigating stress in your body? By taking the wheel of life exam you’ll understand that your personal fulfillment can pay dividends on your health.

Remedy Four: Have Routine Check Ups

This one is easy. Create a relationship with your doctor: Make continuous notes of all your concerns and talk to your doctor about them. Most doctors will only spend a limited time with you, so get your notes together before hand and aim to keep the lines of communication open.

Step Five: Live a Healthy Lifestyle

Be Kind To Yourself: Start by taking a few quiet moments each day to silence the outside world and allow the heart rate to slow. Continue your process to be well by becoming conscious of all that is around you.

Nutrition: Practice becoming aware of what you are putting in your mouth ? try to focus on the naturals: fruits and vegetables and go for lean meats and low fats. Finally, don’t forget to drink your 8-oz glasses of water.

Exercise: Be sure to find an exercise program you enjoy and be consistent with your workouts: My philosophy: spend 1 hour per day at least 5 days a week. This is just a guideline. Find what kind of exercise you enjoy most, and be consistent. Your body will thank you.

In Closure:

Learn to get to know your body. Your body and your relationship to it will give you signals as to how to take care of it. You can keep the drug companies honest by asking questions, challenging information and making the most of the time you spend with your doctor. By creating a positive atmosphere and a positive lifestyle you are certain to find yourself betting on wellness and keeping the pharmaceutical monies right where they belong: in you own pocket.

This past week, the FDA held a meeting in order to decide what should be done about Merck’s Vioxx and Pfizer’s Bextra and Celebrex. The Food and Drug Administration originally intended to ban these pain medications. However, this was challenged by a series of obstacles.

The Cox-2 painkiller prescription medications are back due to popular demand! In spite of the life-threatening side-effects such as heart attacks, many patients feel that the medications have changed their lives for the good.

Many patients claim that drugs such as Vioxx have brought them from living in a wheelchair (practically paralyzed by chronic pain) to living something close to a normal life. These people have been counting down the number of pills (days) they have left until life as they know it is over; and some decided to stand up and make their point at the FDA meeting. One woman even stated that she’d sign any waivers or consent agreements she needed to in order to keep the life she has. No other known medications can help these people. Currently, without the Cox-2 drugs, a life of paralyzing pain is the only other option. For some patients, the benefits outweigh the risks by a longshot.

The FDA has decided against the ban on Cox-2 prescription medications, but has prohibited the advertising of these drugs directly to consumers. Direct-to-consumer (DTC) advertising consists of methods such as television and radio commercials, etc.

The reintroduction of Vioxx and acceptance of Celebrex/Bextra back into the health industry are both possibly great decisions. However, in order to make it work, a decent amount of reform is necessary to ensure patient safety and understanding. We’ll see what happens.

Although the Cox-2 drugs have been reintroduced or accepted into the market, we at Shoppe.MD will stand by our 2004 decision to discontinue the sale of prescriptions for Vioxx, Celebrex, and Bextra. Shoppe.MD online pharmacy does not plan on reintroducing these medications in the future. If you have a difficulty with pain, please talk to your doctor in person.


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