Unfortunately, evidence of this potentially dangerous Avandia information was only revealed after a doctor analyzed data from clinical trials that GlaxoSmithKline was required to post on its website as a result of a legal settlement. Public postings of this kind are becoming increasingly regular, preventing drug companies from disguising scientific information about their medications. In an alarming example of the deceptive practices employed by some pharmaceutical companies, Senate investigators found that GlaxoSmithKline spent years avoiding clear indications that Avandia use increased the risk of heart problems. According to reports, GlaxoSmithKline became aware of the potential dangers of Avandia as early as 1999, and intentionally withheld this information from consumers and federal drug regulators. In response to Avandia side effect information and FDA regulations, GlaxoSmithKline has promised to terminate Avandia promotions around the world.
Avandia is a prescription medication which is used in combination with a diet and exercise program and sometimes one or more additional medications to treat Type 2 diabetes. Avandia (rosiglitazone) belongs to a class of anti-diabetic medications known as thiazolidinediones, which function by increasing the body’s sensitivity to insulin. Avandia is used only in the treatment of Type 2 diabetes, not Type 1 diabetes, a condition in which the body does not produce any insulin, or diabetic ketoacidosis, a condition occurring when high blood sugar is not treated properly. Avandia was approved by the FDA in 1999 and is currently manufactured by pharmaceutical company GlaxoSmithKline.
In September 2010, the FDA announced that it will significantly restrict the use of Avandia, after reviewing new data which suggests that Avandia users may have an increased risk of cardiovascular events, including heart attack and stroke. Shortly after this FDA review, GlaxoSmithKline revised Avandia’s prescribing information to include additional safety information and new restrictions on the use of the drug. The revised label restricts the use of Avandia to patients who are already taking a rosiglitazone-containing medication, those who cannot successfully control their Type 2 diabetes with any other medication, and those patients who have decided not to take Actos (pioglitazone) or other pioglitazone-containing drugs for medical reasons. In response to this new Avandia side effect information, the FDA has also required GlaxoSmithKline to develop a Risk Evaluation and Mitigation Strategy program which will restrict the availability of Avandia and other rosiglitazone-containing medications.
Avandia is an extremely controversial medication in the United States due to the drug’s significant potential for causing serious side effects and even death. In several other countries, Avandia faces severe criticism and use of the drug has already been restricted and terminated in many areas. In Europe, the European Medicines Agency (EMA) recommended late last year that Avandia be removed from the market and encouraged Avandia users to discuss alternative treatment options with their physicians. In the UK, Avandia was effectively removed from the market and Diabetes UK notified Avandia users that they had until October of last year to be transferred to an alternative medication. In New Zealand, Avandia was withdrawn from the market earlier this year due to serious concerns about the drug’s connection to an increased risk of cardiovascular side effects.
Avandia was once considered the biggest-selling diabetes drug in the world, with approximately 600,000 people currently taking the medication in the United States alone. Unfortunately, with new information from Avandia side effect studies, physicians are being advised to avoid prescribing Avandia to patients unless all other available treatment options have failed, and to begin transferring current Avandia users to alternative medications. The side effects potentially associated with the use of Avandia include:
In 2007, the New England Journal of Medicine published a study in which researchers found that people taking Avandia had a significantly increased risk of suffering from a heart attack and an increased risk of death from cardiovascular causes, compared to other anti-diabetic treatments and no anti-diabetic treatment. In 2010, research was presented to the FDA by FDA scientist, Dr. David Graham, who studied nearly 230,000 Medicare patients and concluded that Avandia may actually increase the risk of stroke by 27%, the risk of heart failure by 25%, and the risk of death by 14%, compared to Actos.
According to Graham, more than 100,000 people taking Avandia may have needlessly suffered a stroke, heart failure, heart attack, or death since the drug came on the market in 1999. In 2010, the FDA ordered GlaxoSmithKline to stop enrolling patients in an “unethical” clinical trial (TIDE) comparing Avandia and Actos, another anti-diabetic drug manufactured by Takeda, because of the potential for Avandia to cause devastating harm. The agency also required GlaxoSmithKline to perform an independent assessment of a landmark study (RECORD) of the heart side effects potentially associated with Avandia. According to an FDA medical officer, the original study contained a number of serious errors which undeniably biased the conclusions made by researchers.
The side effects potentially associated with Avandia use are extremely dangerous and may even result in death. If you or a loved one has suffered from a heart attack, stroke, heart disease or heart failure and you believe Avandia to be the cause, contact an Avandia attorney immediately. You may have grounds to file an Avandia lawsuit against GlaxoSmithKline in order to seek financial compensation for your injuries, the medical expenses resulting from treating your injuries, and the pain and suffering endured by you and your family. If you believe the death of a loved one was the result of Avandia use, you may be eligible to file a wrongful death lawsuit against the drug’s manufacturing company in order to seek financial compensation for medical expenses, funeral costs, loss of future income, and pain and suffering. Victims of serious injuries associated with the use of a dangerous drug are not at fault. Some pharmaceutical companies are aware of the dangers of their medications and intentionally conceal this information in order to make their product more desirable to consumers. This puts millions of consumers at risk of suffering severe and life-altering injury, and even unnecessary death. Avandia lawyers are experienced in defective drug litigation and can help victims of alleged Avandia side effects present their case effectively and professionally. Only by hiring an experienced Avandia attorney can you protect your rights and collect the compensation you deserve.