FDA and Restricted Access Due to Avandia Side Effects

Specifically, the FDA has announced that GlaxoSmithKline, the manufacturer of Avandia, is hereby ordered to develop a restricted access program for those who want to use Avandia to treat their type 2 diabetes.  This basically means that people will only be allowed to begin using Avandia if other medications have not performed properly and if these patients are unable to use Actos, another diabetes drug, for whatever reason.  Those patients who have been using Avandia will be allowed to continue to do so, but those who begin using Avandia must be thoroughly warned of the dangers of Avandia side effects that include a heightened risk for heart attacks and strokes.

FDA Scrutinizes Avandia Side Effects Studies

In addition to the announcement above, the FDA also announced that GlaxoSmithKline must convene an independent review of the RECORD study, which was performed in order to measure the risks of heart attacks and strokes in Avandia users.  The FDA has questioned the bias that could have been involved in the conclusions as well as the manner in which certain events were recorded.  Finally, the FDA has killed what is known as the TIDE study, which was ongoing and was being done to compare Avandia to Actos.

If you or someone you love has been harmed because of using Avandia, contact the Avandia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.

Meridia Side Effects Lawyers – First Wave of Problems Arise

After a few years on the market, the first reports of serious Meridia side effects began to make their way into the media.  These Meridia side effects were serious, and similar reports prompted the banning of the sale of Meridia for a time in Italy.  These Meridia side effects included:

• Primary Pulmonary Hyptertension (PPH)
• Heart valve damage
• Heart attacks
• Cardiac valve dysfunction
• Death

Of these initially reported Meridia side effects, PPH was the condition that drew the most attention because it was otherwise rare, easy to miss because of its symptoms being similar to other problems and progressive to the point where it was often too late after PPH was diagnosed.  However, additional problems have recently arisen regarding Meridia side effects.

Meridia Side Effects Lawyers – The New Problem

While all of these reports of Meridia side effects were surfacing, the FDA only went as far as issuing a preliminary statement that it wanted to see the results of a large Meridia study that was in progress.  That study is nearing its completion, and the first set of conclusions are becoming available.  What seems to be the most prominent conclusion that’s been released at this point is the troubling tendency for those who have a history of heart problems to face a high risk of a heart attack if they use Meridia.

As a result of this finding, the FDA has announced that all containers of Meridia must now contain a warning that specifically states that patients with any history of heart problems face this higher risk of a heart attack.  This requirement is one of the more serious steps that the FDA can take, and at this point there’s no telling how many people with a history of heart problems have used Meridia without the knowledge that they were facing this possible result.

Meridia Side Effects Lawyers – How to Proceed

If you or someone you love has been harmed as a result of using this medication, you need to contact the Meridia side effects lawyers at the Phillips National Injury Group as soon as possible to schedule a free initial consultation.  The firm has helped those harmed by defective drugs for many years, and you need to protect your legal rights if you’ve suffered from Meridia side effects.  Contact the firm today.

1.  The Usual Progression

Ocella hit the market recently and well after Yasmin and Yaz were released to the public.  Basically, Ocella is a ‘generic’ form of Yaz, which means that while the active ingredients are mostly similar as are the main purposes for using the drug, there are slight differences that supposedly make the generic version less expensive.  Ocella is basically the latest example of this progression in the pharmaceutical world.

2.  The Manufacturers

Both Yasmin and Yaz are manufactured by Bayer Healthcare, one of the true giants of the industry.  However, in recent years, Barr Laboratories sued for the right to basically invalidate the patent that Bayer Healthcare held on the formula that comprises Yaz and Yasmin and won.  Therefore, they were able to formulate their own product and release it to the public under its own name.

3.  The Formulas

While the formulas are very similar, there are enough differences between them that their effects can vary somewhat depending on the individual using them.  No one is sure how these slight differences will affect any particular patient, but many women report different reactions.

What is not different between Yaz, Yasmin and Ocella is the side effect risk.  These drugs have shown a tendency to lead to side effects that include kidney damage, heart attacks, strokes and even death.  Lawsuits have been filed around the country, and a report recently indicated that Bayer Healthcare had been served with nearly 75 claims after women had developed side effects after using their products.

Therefore, if you have used Yaz, Yasmin or Ocella or even any combination of the three and you’ve suffered from side effects as a result, you need to contact an Ocella lawyer at the Phillips National Injury Group today to schedule a free initial consultation.

• Kidney damage
• Heart attacks
• Strokes
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolisms
• Death

All of these conditions are obviously dangerous, but many women who have been injured are not sure where to turn for help.  Fortunately, an experienced Yaz attorney can help you analyze your situation to decide whether or not pursuing legal action is an advisable step to take.  Below is a look at some of the ways in which an attorney can help you if you’ve been injured:

1.  Analyzing the Progression

Clearly, you began to use Yaz at some point, and your overall health was likely recorded by your doctor at the time you began to use it.  Establishing a baseline in regards to your help will allow you and your attorney to lay out just what sort of suffering you incurred as a result of using this product.

2.  Determining the Liability

While no attorney can guarantee if a potential defendant would be liable in a legal action, an attorney with experience and skill will be able to help you determine if your use of Yaz was the cause of your injuries.  If that turns out to be the case, then it’s possible that Bayer Healthcare could be liable for the damages you’ve incurred.

3.  Quantifying Damages

The final step towards making a decision regarding the filing of a legal action involves organizing the costs involved with your suffering.  This is not always a tangible, numbers-based analysis, but different forms of damages include:

• Medical costs
• Lost income
• Ongoing medical care costs
• Pain and suffering
• Loss of companionship

Obviously these are only a few examples, but you’ll need to obtain an idea of what a claim would be worth if it proves to be successful before making the decision of whether or not to move forward.  In short, if you’ve been injured by this product, you need to seek the help of a Yaz attorney as soon as possible so that you can make a decision regarding how to respond with a basis of knowledge and sound legal advice.  Contact the Phillips National Injury Group today to get the answers you need.

One of the most common side effects that’s been linked to Yaz is the tendency for women to suffer from heart attacks as a result of using it.  Several different theories have been put forth as to the root cause of this problem, but it becomes even more daunting that experts have been unable to identify a specific cause for them.  Some of these theories include:

• The amount of estrogen released into the body can create an imbalance with the circulatory system
• Some women have had a history of heart-related problems and are more susceptible to heart attacks when using Yaz
• Some women have diabetes and/or high blood pressure, creating the same problems
• Obesity has also been linked to heart attacks with women who have used Yaz

Regardless of the specific conclusion, the reality is that there have been enough reports generated of this sort to prompt a public outcry from every corner of the United States.  As a result, 74 lawsuits as of this writing have been served upon Bayer Healthcare claiming injuries because of the use of both Yaz and Yasmin, and that number is expected to continue to rise.

If you are using Yaz and experience any of the following symptoms:

• Chest pains
• Shortness of breath
• General difficulty breathing
• Numbness in your extremities
• Dizziness

You need to contact your doctor immediately.  You should do the same if you experience any sort of abnormal symptoms, no matter how minor they may seem at the time and even if you have no medical history that would warrant a heightened sense of awareness to any problems.  If you have suffered a heart attack or any other injury as a result of using this product, you should also contact a Yaz lawyer as soon as possible to schedule a free initial consultation.

Yaz enjoyed a large share of the market after it was introduced to consumers in the United States in 2001 after being approved by the FDA.  It was made available via prescription, and it was also used for certain off-label uses that included treatment of the symptoms of acne and the symptoms of premenstrual dysphoric disorder, or PMDD.  These symptoms included anxiety, lack of sleep, irritability and dizziness.

Unfortunately, Yaz eventually began to be linked to the development of serious side effects in many women who were using it, and some of these Yaz side effects included:

• Heart attacks
• Kidney damage
• Pulmonary embolisms
• Strokes
• Deep Vein Thrombosis (DVT)

Of those side effects listed above, DVT generated a high level of concern given the difficulty in diagnosing the problem.  DVT is basically a blood clot that forms deep inside the leg, and in some rare cases the arm, but they do not always present outward symptoms that are easy for a doctor to spot.  However, when symptoms do present themselves, they can include:

• Swelling of the leg
• Pain in the affected leg
• Redness in the affected area
• Hot spots on the skin

If DVT is not treated, it can become extremely dangerous and even be fatal in some cases.  Enough of these reports were generated that the FDA ultimately required the manufacturer to place a “Black Box Warning” on all packages of Yaz that clearly warned users of the dangers involved with using it.

Many of those harmed as a result of using this medication also moved forward with Yaz lawsuits against the manufacturer.  If you have suffered as a result of using this medication, you too may have legal rights and options that need to be explored.  You’ll need to contact a defective drugs attorney to schedule an initial consultation, and during that consultation your attorney will look at the information you have regarding the situation and provide you with a recommendation.  Contact an attorney today.

Yasmin is a prescription drug that’s unique in terms of how it works inside the woman’s reproductive system.  In essence, it performs two tasks – it prevents ovulation and it prompts slight changes in the woman’s uterus and cervix.  Basically, if an egg is somehow fertilized despite the presence of the medication, it will not be able to attach to the uterine wall as most fertilized eggs do before they begin to expand and grow.  For a time, Yasmin produced positive results.

However, Yasmin eventually began to be linked to serious side effects, and these included:

• Deep Vein Thrombosis (DVT)
• Heart attacks
• Strokes
• Kidney damage
• Pulmonary embolisms

The Yasmin side effects that seem to be most prevalent are somewhat related, and they are DVT and pulmonary embolisms.  The reason they are related is because one leads to another in many instances.  DVT is a condition whereby a blood clot forms deep inside the leg or sometimes the arm.  When these clots break off and make their way into the circulatory system, they often make their way into the lungs and attach to the tissue there, forming another clot.

Blood clots in the lungs are known as pulmonary embolisms.  Many of these clots are quite small and can be managed, but some grow quickly or are not caught early in their development.  As a result, pulmonary embolisms that are not properly and promptly treated can be deadly for the patient.  Clearly, these are dangerous conditions that can arise in otherwise-healthy women.

The FDA responded by announcing that Yasmin would be required to carry a “Black Box Warning” on all labels of the medication, and these warnings were meant to clearly warn anyone who sees them of the dangers involved.  Yasmin has not yet been recalled, which means that those consumers who have been injured by this medication need to find recourse by way of filing a Yasmin lawsuit.

If this has happened to you or someone you love, you need to look into taking the same action.  All you need to do is bring any information that pertains to your history of use of Yasmin, and your defective drugs attorney will be able to help you determine if filing a civil claim is an advisable step for you to take.  Contact an attorney today to schedule a consultation and to get this process started.

In response to this need, companies began to introduce medications that were meant to help control this bleeding, and Bayer, A.G. introduced a drug that was approved in 1993 that soon penetrated the market with a high degree of depth.  The medication was known as Trasylol, and experts have estimated that millions of patients had this drug injected into their systems prior to surgery.

For several years, Trasylol appeared to work quite well.  However, the publication of a study by the New England Journal of Medicine (NEJM) in 2006 set off a chain reaction of discovery by patients and negative reports that ultimately led to the recall of the medication after much involvement by the FDA and the federal government.  The side effects included the following:

• Kidney failure
• Strokes
• Encephalopathy
• Heart attacks

Heart attacks proved to be the most prevalent of Trasylol side effects, and the study by the NEJM concluded that those who had heart surgery and had received an injection of Trasylol faced a much higher risk of heart attacks and other side effects than those who did not.  In addition, some estimates indicate that as many as 22,000 people died as a result of using this medication and another 11,000 required ongoing medical treatment.

The recall came about after the FDA requested that the manufacturer stop marketing Trasylol in 2007, and in 2008, the full recall was initiated.  While this likely saved lives, it did not help those who had already suffered.  As a result, Trasylol lawsuits were filed all over the United States, and if you have suffered as a result of using this medication, you may have that option as well.

If you’d like to explore those options, all you need to do is contact a defective drugs attorney to schedule a free initial consultation.  You’ll only need to gather whatever information relating to your injection of Trasylol that you can find, and your attorney will handle the details from there if you have a valid claim.  Contact an attorney today to get this process started.

Unfortunately, many who used Avandia eventually began to develop serious side effects, and these included:

• Severe allergic reactions
• Severe chest pain
• Strokes
• Heart attacks
• Death

Those who have been found to be in a position of high risk include anyone who has had a history of heart problems in the past.

Ultimately, the US Food and Drug Administration (FDA) issued a public health warning in regards to Avandia and the increased risk of heart attacks and other serious problems for those who were using it.  This announcement followed the publication of a study by the New England Journal of Medicine that concluded that those who used Avandia faced a higher risk of a heart attack by as much as 43 percent.

If you or someone you love has been harmed as a result of Avandia side effects, you have legal rights and options, but you’ll need to work with a defective drugs lawyer in order to obtain a full set of answers that directly relate to your situation.  If you and your attorney decide that filing an Avandia lawsuit is a sound decision, you’ll need to help your attorney get the process started by providing him or her with a few pieces of information.  These include:

• Documentation regarding your Avandia prescription
• Dates you took the medication
• Any medical records pertaining to problems you encountered as a result of using Avandia
• Any insurance documentation regarding your health situation that relates to your use of Avandia
• Any other information you think could be relevant

This is not an exhaustive list, and you’re only going to serve yourself better if you err on the side of over-inclusion when it comes to potential evidence.  After you’ve provided your defective drugs attorney with the information he or she needs, you can likely focus on your recovery and allow your attorney to handle your claim.  If you’ve suffered from the use of Avandia, contact an attorney today to schedule a free initial consultation.