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.

FDA Puts Hold on Enrollment for Avandia Side Effects Study

For several months, the issue of whether or not Avandia should be pulled from the American market has been raging.  Most recently, a federal panel of experts voted to keep Avandia on the market for now by a narrow margin, but the demand for more information was clear.  One of the biggest sources of information in this regard was supposed to be gleaned from what is known as the ‘TIDE’ study, which was to recruit up to 16,000 subjects to take part.

As part of the study, some patients were going to agree to take Avandia, while others were going to take Actos, which is a direct competitor of Avandia.  A third group would serve as the control group and would not be given any medication.  As of now, approximately 1,100 subjects have agreed to take part in this study, but the FDA has recently announced that no additional patients would be allowed to enroll in the TIDE study.

Why Learning More About Avandia Side Effects Is Important

As stated above, the Avandia side effects issue is extremely important because of the extreme danger that many people who have used this drug have encountered.  These Avandia side effects that include heart attacks and strokes have been far too prevalent for many in a position to lead to change, and this high level of concern has led to restrictions imposed on Avandia by the government and a plethora of lawsuits filed against GlaxoSmithKline.

If you or someone you love has been harmed as a result of using this drug, you need to take action by contacting the Avandia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.

One of the steps that’s being taken today and tomorrow is a discussion by a federal panel of experts regarding whether or not Avandia should remain on the market given its purported utility versus the potential for Avandia side effects.  In furtherance of this discussion, studies will be reviewed to dissect the statistics regarding the probability of someone developing Avandia side effects.

The RECORD Study Regarding Avandia Side Effects

GlaxoSmithKline has been depending on a study regarding Avandia side effects known as the RECORD study.  This study tracked more than 4,400 patients, some of whom were given Avandia and others who were given other diabetes medications.  The results of the RECORD study concluded that people are no more likely to develop Avandia side effects that include heart attacks and strokes than they are if they take other medications.

The FDA’s Reaction to the Avandia Side Effects Study

The FDA also reviewed the results of the RECORD study, and the agency did nothing short of blast the results.  The agency stated that the following problems existed with RECORD:

1. Researchers sloppily compiled the data in the study
2. Researchers failed to follow up on reports of Avandia side effects
3. The entire study was biased at its foundation

These are extremely strong criticisms, and they could be very persuasive in regards to the ultimate decision that’s made sometime this week in terms of Avandia’s place on the market.

How an Avandia Side Effects Lawyer Can Help

Regardless of what’s decided by the panel in regards to Avandia, many people have already suffered greatly from Avandia side effects.  If this includes you or someone you love, you need to take action to protect your legal rights.  Contact the Avandia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.

Avandia Side Effects are Extremely Prevalent

Now comes word that an exhaustive Senate report on Avandia has been completed and released, and the overall conclusion of this report is anything but positive for Avandia, GlaxoSmithKline and those who are or have used Avandia over the years.  The report was based on a review of over 25,000 pages of documentation related to the drug, and the findings by those who formulated the report include:

• Avandia could be responsible for as many as 83,000 heart attacks since the drug hit the market.
• GlaxoSmithKline made efforts to undermine and/or discredit negative information regarding Avandia.  The report specifically states:

“”GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

• The FDA was guilty of overlooking data that indicated that Avandia carried risks for those who used it.

Avandia Somehow Remains on the Market

Despite these findings and other reports that have been generated over the years, Avandia remains on the market.  The FDA has required that warnings be attached to the labels of Avandia, but the absence of direct government action has led to the need for those injured by Avandia side effects to seek justice by themselves.  When this sort of situation plays out, it leaves those injured by Avandia side effects with only one option – to take GlaxoSmithKline to court in pursuit of justice.

If you or someone you love has been injured as a result of using Avandia, you too need to take action to protect and enforce your legal rights.  Contact the Avandia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.

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.