GSK was facing about 2,000 lawsuits alleging it covered up Avandia’s heart attack and stroke risks. The company previously agreed to pay about $460 million to resolve allegations it didn’t properly warn doctors and consumers about the medicine’s risk. That news brought more lawsuits against the GSK, and more settlements to the forefront.

The drug was pulled from the European market and severely restricted in the United States last September, after studies linked Avandia to an increased risk for cardiovascular events. This week, the Food and Drug Administration (FDA) approved label changes for Avandia and outlined the standards that patients must meet before they can take the drug.

Those guidelines state that the drug should only be used in patients already being treated with rosiglitazone, in patients whose blood sugar cannot be controlled with other anti-diabetic medications, and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medications, another type of diabetes drug that includes the brands Actos, Actoplus Met, Actoplus Met XR, or Duetact.

Avandia is a single-ingredient product and is also sold as a combination product under the brand name Avandament (with metformin) and the brand name Avandaryl (with glimepride).

Studies suggest as many as 100,000 heart attacks may have been caused by the drug.

SOURCE: Avandia Recall › GSK pays out more money to settle lawsuits against deadly diabetes drug

“I was having severe chest pains and I was hospitalized and told at a later time that taking Avandia could cause the severe pain I was having,” Joyce says. “I thought that I was having a heart attack, but they did a stress test and said that the pain was not a heart attack. But it was something strenuous under the heart.”

Joyce says she was put on Avandia in 2002 or 2003 and was only taken off it after she was hospitalized in 2007. “The pain just got worse and worse through the years,” Joyce says. “I’m still having some small chest pains, but it’s not as serious as it was. Sometimes, I still get little ‘catches’ under my heart that haven’t completely gone away. I’m trying to take it easy, watch my weight and watch what I eat. I also had swelling in my ankles and feet. I still get that sometimes, too. But that’s not as bad as it was.

“Walking distances would cause my chest to tighten up a little bit. But, I could just be lying in bed and my chest would tighten up. Not just walking makes it tight. I was scared to do strenuous stuff because of my chest tightening up. After the last time I was in the hospital, I saw my new doctor and told him I was taking Avandia. He said, “We’re taking you off that today.’ And since then I’ve been somewhat better but I still have some pains. It hasn’t even been a good two months since I stopped taking it.

“I’m really scared of Avandia now. It’s scary when it’s messing with your heart. I think Avandia is a big risk to your health and a big risk to your heart.”

Fortunately for Joyce, she did not suffer any heart attacks while taking Avandia. Hopefully, she will make a full recovery and stop experiencing chest pains and swelling in her ankles. Other patients have allegedly suffered life-threatening heart problems while taking Avandia. Some are filing lawsuits against the maker of Avandia, alleging GlaxoSmithKline knew about the problems associated with Avandia but did not properly warn patients about those risks.

January 8th, 2008 by Heidi Turner with LawyersandSettlements.com

SOURCE: Avandia Recall › Avandia a big risk to your heart

Grant started taking Avandia two years ago after he was diagnosed with type 2 diabetes. Prior to taking Avandia, he had no history of heart problems. “Grant had never had any problems in the past,” Mark says. “He had a clean bill of health in terms of his heart prior to that. There was no history of heart disease in our family.”

Within a year of being on Avandia, Grant was diagnosed with high blood pressure. Within two years, Grant was diagnosed with 80 percent blockage of his arteries. He required a quadruple bypass surgery. Grant went in for the surgery on a Monday, but experienced some complications and came out of the surgery with a heart fibrillation.
Only three days after the surgery, Grant suffered a massive stroke, which left him paralyzed on his left side and unable to speak. “We don’t know what caused the stroke, but we assume it had something to do with his requiring the operation to begin with,” Mark says.

Furthermore, Grant’s kidneys shut down and he developed swelling on his brain. Luckily, after two days of dialysis, Grant’s kidneys began to function again and he regained his ability to speak three weeks later. However, damage to his brain was about 25 percent.

“The surgeon and the doctor controlling Grant’s diabetes were surprised he was there with blocked arteries, considering his health prior to this,” Mark says. “They couldn’t believe that a 45-year-old had the problems Grant had.”

Some people might think that Grant’s stroke and other problems were caused by complications from the surgery and that Avandia had nothing to do with it. However, would Grant have required the surgery if he had not been on Avandia? Even if Avandia did not directly cause the stroke, it may have been an indirect cause because it pushed Grant’s blood pressure up and started a chain of events that culminated in his stroke.

“Grant will probably never be 100 percent,” Mark says. “He had 25 percent of his brain affected by the stroke. He was an amazing musician, so that’s rough for him. He’s lost a lot of quality of life. Having said that, he’s got a sense of humor and he’s working hard.

“In Grant’s room, a room of eight people, there were four other patients that had open-heart surgery that had also been on Avandia. Something must be going on-some doctors must have an idea of what is going on.

“It’s starting to sound a lot like Vioxx, where statements are made that the risks outweigh the benefits.

“I just want some justice done here for my brother.”

December 22nd, 2007 by Heidi Turner with LawyersandSettlements.com

SOURCE: Avandia Recall › Avandia starting to sound a lot like Vioxx