Diabetes Clinical Trial Halted Due to Deaths – Avandia Safety Called into Question Again
February 6, 2008
The government announced Wednesday that the 10,000 patient ACCORD clinical trial involving diabetes treatment has been halted 18 months early due to increased risk of patients death. The trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%.
The results bring into question the methods used of lowering blood sugar actually protects the heart and is very likely to call the safety of the diabetes drug Avandia into question, yet again.
Although the research does not indicate a link between Avandia use and increased deaths, Steve Nissen, who linked Avandia use to increased risk of heart attacks, states, “"It's very hard to sort out," and "We've got to be careful not to jump to conclusions.". Nissen went on to say "Clinicians have been taught that getting to lower blood sugar is better” and “its really going to shake things up”.
Avandia was recently back in the news, when it was found that Dr Steven Haffner, admitted leaking information about a study linking the drug to a 43% greater risk of heart attacks to GlaxoSmithKline PLC 17 days before the article was published in the New England Journal of Medicine, last May.
Our law firm is currently investigating claims involving the use of Avandia and death, heart attack, congestive heart failure as well as fractures in the hands and feet. If you or a loved one has taken Avandia and experienced any of the above situations, please contact our firm today.
First approved by the Food and Drug Administration in 1999, Avandia is a drug designed by GlaxoSmithKline intended to treat type II diabetes. This condition, commonly called adult-onset diabetes, affects millions of people across the world.
Diabetes type II is characterized by insulin resistance, which means that the insulin in the body does not absorb glucose in the blood stream. Avandia helps these patients moderate the amount of sugar in their body in order to prevent the serious complications type II diabetes can cause such as:
- Renal failure
- Blindness
- Coronary artery disease
- Slow healing wounds
The symptoms of type II diabetes are often so subtle that they are confused with other, less dangerous conditions or ignored entirely.
Avandia has been linked to a rare condition called Primary Pulmonary Hypertension, a dangerous and potentially fatal condition that can cause damage to the lungs and heart. It occurs when blood vessels such as the pulmonary artery to the lungs narrows and increases blood pressure to dangerous levels. If the pulmonary artery cannot function properly it can result in heart failure and dangerous levels of fluid build up in the lungs and other body parts.
Unfortunately, Avandia has a number of extremely dangerous and potentially-fatal side effects to the liver including:
- Jaundice (yellowing of the eyes and skin)
- Dark urine
- Fatigue
- Loss of appetite
- Nausea
- Vomiting
- Stomach pain
These side effects should be treated immediately by medical professionals as they could be signs of serious liver damage.
Furthermore, Avandia is also linked to heart failure and hypoglycemia, or extremely low blood sugar.
Heart failure symptoms include
- Chest pain
- Swelling of the extremities
- Weight fluctuations
- Difficulty breathing/Shortness of breath
Hypoglycemia symptoms include:
- Dizziness
- Headaches
- Accelerated heart rate
- Weakness
- Sweating
- Fatigue
Avandia can also cause a rare but life-threatening condition called primary pulmonary hypertension. This condition is caused when blood vessels narrow, causing the heart to pump harder and in turn increase blood pressure. The heart must pump harder to supply the lungs with blood, and eventually this will weaken the heart muscle itself and result in total heart failure.
If you or someone you love was affected by the side effects of Avandia, you may be entitled to financial compensation for your situation. Let our experienced and aggressive defective drug attorneys help you get the justice you deserve. Contact us today.
Images portrayed in this site are not actual clients. It is not implied that images of
people on this site are real or have had their health harmed or affected from using Avandia.
