Avandia: July 2007 Archives

Avandia Heart Risks May Be "Inconclusive"

Researchers from the New England Journal of Medicine are reporting that data on Avandia's overall heart risks are "inconclusive." Researchers say that they have not yet established if there is an association between Avandia and heart attacks or Avandia and heart disease in general. The Food and Drug Administration says that Avadia and another diabetes drug, Actos, will be required to carry a "black box" warning about the heightened heart attack risk from taking the drug.

Avandia Heart Risks May Be "Inconclusive"

In May, researchers conducting an interim study found that Avandia appeared to increase the risk for heart problems. The maker of Avandia, GlaxoSmithKline, says that the findings are flawed because the data that was analyzed was not specifically looking for heart risk. A more recent study in which half of the participants took Avandia and a combination of metformin and sulfonylurea and the other half of the participants only took sulfonylurea-metformin found that there was not an increased risk of heart attack or heart problems in general in patients who were taking Avandia. However, heart failure was 2.15 time more common in the Avandia group.

Posted by Patricia Bowling at 01:24 PM | Permalink

Avandia May Get Bone Warning

GlaxoSmithKline Plc's diabetes drug Avandia may soon have a warning label to consumers advising that the drug causes an increased risk of bone fractures. A recent study shows that Avandia leads to an increased risk of broken bones in women. The effect has not yet been studied in men.

Glaxo's Avandia May Get Bone Warning, Analyst Says

Andrew Baum, a Morgan Stanley analyst, says that the new data "suggests that thiazolidinedione treatment is a risk factor and can contribute to excess incidence of fractures in diabetes." Baum is "almost certain" that Avandia will get a new warning about fracture risks in women on its label. GlaxoSmithKline, the manufacturer of Avandia, says that the study's conclusions are "limited" and that any clinical relevance cannot yet be determined.

Posted by Patricia Bowling at 02:11 PM | Permalink

Congress Works to Balance Drug Safety and Fast Approval

The recent safety concerns over Vioxx, Ketek, and Avandia are highlighting the longstanding debate on how prescription medications should be approved for use by American consumers. The safety of the three drugs was called into question after the Food and Drug Administration approved them for use. Vioxx has been implicated in thousands of heart attacks, Ketek causes liver failure, and the health hazards of Avandia have only just begun to be realized.

Congress Seeks to Balance Drug Safety, Quick Approval

Jerry Avorn, a Harvard Medical School physician, says that he is "deeply disappointed in the way things are headed." He believes that not enough money is spent on "pharmocovigilance;" the term refers to the ongoing study of drug safety.

Posted by Patricia Bowling at 02:22 PM | Permalink

New Data Show Those Taking Avandia Had Lower Medical Costs

Recent data from more than 15,000 patients with type 2 diabetes show that initial therapy with Avandia was associated with significantly lower medical costs and total visits to the doctor compared to patients who were treated with a sulfonylurea. Dr. Mel Sheng Duh, the co-author of the study, said, "the study findings demonstrate that treatment with Avandia resulted in significantly lower total medical costs for the patient over time, when compared to sulfonylurea therapy. These data are important to physicians selecting treatment for their patients because the financial burden of diabetes and its associated health problems is staggering -- not only to patients but to their families and the healthcare system as well."

New Data Show Patients Treated With Avandia(R) (Rosiglitazone Maleate) Incurred Lower Medical Costs and Used Fewer Healthcare Resources When Compared to Patients Treated With Sulphonylureas

Main findings from the study indicate that the total direct medical costs were significantly lower in the group taking Avandia compared to the sulfonylurea group. The study looked at real-world medical, pharmacy, and disability insurance claim data from more than 3,000 patients treated with Avandia.

Posted by Patricia Bowling at 12:58 AM | Permalink

Avandia Maker Sued Over Heart Attack

Larry Alan Stanford's widow and son are suing GlaxoSmithKline, the maker of the diabetes drug Avandia. Peggie Stanford, Larry's widow, says that her husband died as a result of having taken the drug. Larry Stanford died on May 21 from a heart attack. Stanford had been taking Avandamet, a form of Avandia, combined with another diabetes drug, since early 2005.

Avandia Maker Sued Over Heart Attack

Stephen Drinnon, the lawyer representing the Stanfords, says that he "believes the evidence will show the company knew there were problems with Avandia but decided to keep on selling it to Larry and others." A GlaxoSmithKline spokeswoman responded that the company will "vigorously defend our medicine."

Posted by Patricia Bowling at 12:29 AM | Permalink

Understanding How PPAR-Gamma Agonists Work

The peroxisome proliferator-activated receptor, PPAR-gamma agonist, class of drugs is the fastest-growing class of drugs in the type 2 diabetes market. Currently, GlaxoSmithKline's Avandia and Takeda's Actos are the fastest-growing class of drugs in the type 2 diabetes market.

Understand How Recent Safety Concerns Will Affect PPAR-Gamma Agonists

Recent evidence has suggested that Takeda's Actos actually lowers heart risk. This calls into question what makes Avandia a dangerous drug, if it is even a dangerous drug.

Posted by Patricia Bowling at 12:21 PM | Permalink

Drug Similar to Avandia Actually Cuts Heart Risk

Actos, a diabetes drug made by Takeda Pharmaceutical, appears to actually lower the risk of heart attack and death by 44 percent in diabetic patients with kidney disease. The findings were made based on the data collected from a group of patients enrolled in a previous study. In a different study, Actos reduced inflammation and blood clots more than a placebo. Takeda's drug is in the same family as Avandia, the drug recently shown to increase heart attack risk. The data from Actos suggests that the problems with Avandia aren't linked to other drugs in the same family.

Robert Spanheimer, the senior medical director for diabetes at Takeda, says that "Actos works even if you're in the highest of the highest risk populations." Many doctors have begun switching patients who had been taking Avandia to Actos.

Posted by Patricia Bowling at 12:02 PM | Permalink

Avandia Leads to Debate at Diabetes Meeting

Diabetes experts and doctors debated the safety of diabetes drug Avandia at the American Diabetes Association's annual meeting in Chicago. GlaxoSmithKline's drug Avandia has been the center of controversy ever since an analysis published last month in the New England Journal of Medicine showed that taking Avandia led to a 43 percent increase in heart attack risk and a 64 percent risk in the rise of heart death.

Glaxo's Avandia Stirs Debate at Diabetes Meeting

Dr. Steven Nissen, the researcher who conducted the analysis, defended his results: "What was the alternative? Not to know? The alternative was unacceptable: to keep the scientific community in the dark." However, many other researchers still disagree with the findings because Nissen based his conclusions on data collected in studies not designed specifically to look at heart attack risk. John Buse, the chief of endocrinology at the University of Chapel Hill, North Carolina, says, "if you take a study not designed to look at heart attacks, can you make a conclusion."

Posted by Patricia Bowling at 11:45 AM | Permalink

July 13, 2007

Avandia Heart Risks May Be "Inconclusive"

July 12, 2007

Avandia May Get Bone Warning

July 07, 2007

Congress Works to Balance Drug Safety and Fast Approval

July 06, 2007

New Data Show Those Taking Avandia Had Lower Medical Costs

July 05, 2007

Avandia Maker Sued Over Heart Attack

July 04, 2007

Understanding How PPAR-Gamma Agonists Work

July 03, 2007

Drug Similar to Avandia Actually Cuts Heart Risk

July 02, 2007

Avandia Leads to Debate at Diabetes Meeting