Avandia Warnings Might Have Prevented a Death

posted on:
July 27, 2007

author:
Staff

 Dallas, TX: Neil Pender's father passed away five years ago from a heart attack and he is angry. "My father started taking Avandia shortly after it was approved in 1999 but we didn't hear about the dangers of this drug until June of this year," says Pender. 

"My father, Roy, wasn't aware that he was a diabetic, but he did have high blood pressure," says Pender. "In 2001, he had a routine blood check and discovered he had high blood sugar. He was prescribed Avandia and placed on a diet. (He wasn't obese but definitely a big man.) Roy didn't have any other health issues and no heart problems-except for the high blood pressure-and was in pretty good health. In fact he had a complete physical exactly three weeks prior to his heart attack.

"He was a shop foreman for an oilwell service so he was very active-he almost made it 48 years at the same job. He came home from work one day and complained that he was too hot and had nausea. My mum and I tried to get him to see the doctor but he said it wasn't necessary, and he just needed to cool off. But it wasn't hot outside and this gave us cause for concern. Within 30 minutes, he collapsed on the floor. We called 911: the first responders were there immediately and they took him to our local hospital. His physician met us and they gave him IV right away. Then they had to transport him to a larger hospital-he'd had a heart attack.

Roy was coherent when he got to Ardmore Hospital's ER and they were going to move him to ICU. Sometime between moving him from ER to ICU, he went into cardiac arrest. He never recovered and stayed on life support until the following day. My Dad was only 66. It was a shock because there were no warning signs: he was never sick. Roy had back surgery in the early 1970s and that was the only time he'd ever been in hospital.

We were devastated. In November 2001 he complained to his doctor of being tired all the time and he'd had problems with his feet swelling so they took him off Avandia-he had taken this medication daily for five months.

I was watching TV recently and saw the Avandia hearings and the attorney ads; that drug stuck in my head; it was so long ago but I remembered that name. I pulled his medical records (I already had them in my possession for insurance purposes) and sure enough, Avandia had been prescribed in July, 2001.

I was angry. How many other people have suffered from taking this drug? When I read these articles about Avandia, I just see dollar signs for GlaxoSmithKline, the drug maker. From what I gathered, Glaxo knew there were problems, way before they put warnings on the label. From my research, there were no significant warnings on the label before 2003.

I am also really concerned about my brother-he is currently taking Avandia. When I started doing this research, I told him about my concerns so he spoke to his doctor. Astoundingly, the doctor said there was nothing to worry about!

This makes me wonder how many people are still unaware of Avandia and its direct link to heart attacks. A lot of people don't pay attention; they just trust their doctor and their government to protect them; they take their meds and do what they are told-to their detriment and possibly, their death.

My lawyer is now in the process of acquiring all my Dad's medical records. He has mentioned the possibility of two diabetic drugs that will be pulled from the market, one of them being Avandia.

I'm telling you about my Dad because I hope to warn others that Avandia should be pulled from the market. If your doctor directs you to stay on Avandia, I would get a second opinion. I sometimes think some doctors get a payment or kickback from these drug companies-I want people to be aware before they become the next victim.

One statement I want to share with you from the FDA hearing was that one person had a difficult time finding the warning because it wasn't prominent enough on the packaging. At our pharmacy, we get a print-out about side effects and warnings. The only thing my Dad got was "can be taken with food." That was the only information besides the label that was supplied to him in 2001.

I'm glad now that my mum is a pack-rat! I would have thrown out his old meds. I remembered reading on the Internet that warnings were changed in 2003 to include cardiovascular problems. As a consumer and a person with common sense, anything can have a side effect but most of them won't disable or kill people like Avandia did."

On July 26, 2007 Scientific American reported that the FDA is asking outsiders if Avandia should stay on the market. The agency has "considerable concern" about data that shows possible heart attack risks with Avandia, and that "various data present somewhat inconsistent findings."

The FDA's advisory panel was given more than 400 pages of documents to review of Avandia's heart risks. They will be asked if Avandia does raise the risk of heart attack and if affirmative, how it compares to other diabetes drugs.

If the advisers decide to keep Avandia on the market, the FDA will discuss other steps such as adding a "black box" warning or limiting use to certain patients.

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