Avandia Restrictions
Avandia Restrictions Issued
The U.S. Food and Drug Administration has announced that rosiglitazone-containing medications—including Avandia, Avandamet and Avandaryl—will face new restrictions. These medications are used to treat type II diabetes.
The new Avandia restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a statement. The REMS program is in place for the management of marketed drugs with serious health risks for the patient. The restrictions being imposed on rosiglitazone-containing medications are due to the fact that data suggests that there is an elevated risk of heart attack in patients treated with the drug.
Avandia Restrictions will require Patients to Enroll In Program
Previously, the REMS for rosiglitazone, which was initially enacted on Sept. 23, 2010, mandated only that a Medication Guide be provided with the medication. Now, the Avandia restrictions will require healthcare providers and patients to enroll in a special program to prescribe and receive rosiglitazone-containing drugs, Avandaryl and Avandamet.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia; it is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
According to the REMS, called the “Avandia-Rosiglitazone Medicines Access Program,” limits for the use of rosiglitazone-containing drugs include the following:
- Patients already being successfully treated with these medicines.
- Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Avandia Restrictions to take affect November 18, 2011
After Nov. 18, 2011, rosiglitazone-containing medications will not be available through retail pharmacies. Rather, patients enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their prescriptions via mail order, which will be sent to specifically certified pharmacies participating in the program, the FDA explained.
Patients currently taking a rosiglitazone-containing medication should contact their healthcare provider as soon as possible, to determine if they should continue taking their current medication and, if so, to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. The patient’s healthcare provider will have to complete and sign the patient enrollment form.
The FDA advises healthcare providers that they should determine whether their patients should be taking rosiglitazone medications, based on risks and benefits of the drug versus other available medications. Additionally, healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe the medications.
Access the Avandia-Rosiglitazone Medicines Access Program online, and read more about the restrictions of rosiglitazone-containing medications on the FDA website as well as the Avandia restrictions.
Categories: Avandia Restrictions, Avandia Side Effects Tags:
Avandia Lawsuit
Avandia Lawsuits are on the Rise
As a result of all the side effects, along with the warning label issues, many people may be entitled to legal compensation. There are legal statutes involved with filing an Avandia lawsuit, which means lawsuits must be filed within a given time frame.
An Avandia Lawsuit and your Doctor
The first step is to schedule a consultation with your doctor to evaluate the side effects of Avandia. A doctor will be able to determine if heart or liver issues are the result of using Avandia. There are other factors to consider. Taking Avandia in conjunction with other medication can also lead to issues.
Medications like steroids, nitrate drugs, seizure and thyroid drugs, and diuretics may increase the chance of side effects if you take them with Avandia. Family history is also a factor. If conditions like heart failure or high blood pressure run in your family, you could be at increased risk. These are all factors that should have been included on warning labels. If issues like these were not made clear, there could be groundsSide effects of Avandia
- Shortness of breath
- Difficulty breathing
- Nausea
- Unusual fatigue
- Changes in vision
- Dark urine
- Fractures or broken bones
- Jaundice
- Swelling in ankles or legs
- Loss of appetite
- Rapid increase in weight
- Vomiting
Avandia Lawsuit based on Side Effects
If there are side effects similar to the ones mentioned, an Avandia lawsuit is worth investigating. The drug company is responsible for ensuring your health, and they are obligated to list all possible side effects on their labels. With all the risks involved, it is important to act fast and evaluate the need for potential legal action.
Fill out the Free Case Review Form on the right and we will have an experienced attorney contact you to discuss your Avandia lawsuit.
Categories: Avandia Lawsuit, Avandia Side Effects Tags: avandia, avandia claim help, avandia claims, avandia lawsuit
GlaxoSmithKline is starting to settle Avandia injury claims!
In May 2010 GlaxoSmithKline PLC reportedly agreed to pay $60 million in Avandia Injury settlements to about 700 Avandia patients over side effects of their diabetes drug. GlaxoSmithKline still faces more than 13,000 other lawsuits filed across the United States alleging that they failed to adequately warn about the risk of heart attacks, heart failure, stroke and other injuries.
Join the Avandia Injury Lawsuit
GlaxoSmithKline has agreed to pay $460 million to settle Avandia lawsuits alleging that diabetes drug Avandia caused:
- Deep Vein Thrombosis DVT
- Heart Attack
- Pulmonary Embolism
- Stroke
The average Avandia settlement for each person injured by Avandia is estimated to be approximately $50,000.
We connect you with experienced Avandia injury lawyers that will fight for your Avandia injury claim.
Avandia Injury cases can be very complex and serious injuries include side effects such as Heart Attack, Stroke, Congestive Heart Failure, Diabetes and Death.Finding the right Avandia Injury lawyer to handle your case can be a very difficult and time consuming task. Navigating through the legal process can be complicated and we will prepare you for this process.
Many Avandia Injury cases can be resolved without the expense and trauma of going into a courtroom. But some cannot. Our Avandia lawyers are experienced and will get your Avandia Injury claim resolved to your satisfaction, in or out of court, as quickly and painlessly as possible. We are to help your family sort through the legal issues resulting from an Avandia Injury.
Avandia Injury Claim Compensation
- Future medical bills
- Loss of earning capacity in the future
- Pain and suffering
- Past lost wages
- Past medical bills
Fill out the Free Avandia Injury Case Review Form on the right
Use our Free Avandia Case Review Form on the right and we will connect you with the right people that can walk you through the claim process and get you the compensation that you deserve.