Bayer AG announced a seven-country recall of Contour TS diabetes test strips due to a manufacturing problem that could lead to blood sugar readings higher than actual levels of glucose. According to a release from the U.S. Food and Drug Administration, glucose test results returned by the recalled strips generally show up five to 17 percent higher than the user’s actual glucose levels.

The recalled Contour TS test strips have lot numbers beginning with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). The recalled lots have the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence.

Consumers may contact Bayer at 1-800-348-8100 to return recalled test strips for a replacement.

Source: U.S. Food and Drug Administration, MedWatch, “Test Strip Recall for CONTOUR TS,” December 21, 2007.

On November 7, 2007, Novartis AG announced that high doses of its diabetes drug, Galvus, could cause liver-safety problems. The announcement has delayed the drug’s path to approval and has raised questions about its future. The company said it would seek a revision to fix the problem before introducing it in Europe.

Patients taking 100 milligram doses of Galvus once-a-day were more prone to have liver-enzyme elevation when compared to patients taking 50 milligrams a day or 50 milligrams twice daily. Recommendations from the company will probably include changing doses to once- or twice-daily 50 milligram doses.

Galvus was approved by the European Union, but the new finding and announcement may delay its debut by several months as the label is finalized. Novartis intends to submit Galvus for approval in the U.S. in 2009, where separate skin toxicity warnings have set back its approval.

The drug is called a DPP-4 inhibitor, which is designed to enhance the body’s ability to lower elevated blood sugar, and may help control Type 2 diabetes. Drug makers also believe they could become blockbuster drugs because they are not associated with weight gain, a major side effect of some established drugs.

Source: “Novartis Diabetes Drug Delayed,” Reuters, November 7, 2007.

The United States Food and Drug Administration (FDA) asked Amylin Pharmaceuticals to change its type 2 diabetes drug’s label to include a warning of acute pancreatitis. The recommendation comes after the agency received 30 reports of the illness in patients taking the drug, Byetta.

Twenty-one patients were hospitalized, five of whom developed serious complications of pancreatitis, such as dehydration and renal failure. Pancreatitis symptoms in six patients began or worsened soon after their dose of Byetta was doubled. Details from three patients indicated the symptoms of pancreatitis returned when Byetta was restarted.

In some of these cases, the FDA said, this evidence suggests an association between Byetta and acute pancreatitis. The agency recommended doctors instruct patients who are taking Byetta to seek medical care if they have unexplained persistent abdominal pain, possibly accompanied by vomiting. If doctors suspect a patient is showing symptoms of pancreatitis, they should discontinue the drug.

Source: Peggy Peck, “FDA wants pancreatitis caution added to exenatide (Byetta) label,” MedPage Today, October 16, 2007.

On August 14, 2007, the U.S. Food and Drug Administration (FDA) announced it was placing a black box warning on a class of diabetes drugs that includes Avandia. The warning, which is the most serious warning the agency can give, says the drugs are linked to an increase in heart failure.

The drugs receiving the warning are in a class of antidiabetic drugs called thiazolidinedione. The drugs which will receive the black-boxed warning about heart risks include:

Avandia (rosiglitazone) Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride) Avandamet (rosiglitazone and metformin) Duetact (pioglitazone and glimepride)

The FDA reviewed adverse event reports for the drugs and found cases of significant weight gain and edema (swelling), which are considered warning signs of heart failure. Continuation of these therapies has also been associated with patient deaths.

Heart failure is a condition characterized by the heart’s inability to properly pump blood. It is a condition that develops over time, and differs from a heart attack.

GlaxoSmithKline manufactures Avandia, Actos and Avandaryl. Avandia was the focus of a July 2007 FDA review because of a possible link to heart attacks. The panel agreed to allow the drug to continue to be marketed.

Takeda manufactures Avandamet and Duetact.

Sources: Jennifer Corbett Dooren, “FDA requires Avandia, Actos to have ‘black box’ warning,” Wall Street Journal, August 15, 2007; “Manufacturers of some diabetes drugs to strengthen warning on heart failure risk,” Food and Drug Administration [Press Release]; August 14, 2007; “Information for Healthcare professionals,” Food and Drug Administration [Information Sheet], August 14, 2007; “Information for Healthcare professionals,” Food and Drug Administration Information Sheet, August 14, 2007.

On July 11, 2007, the National Institute of Diabetes and Digestive and Kidney Diseases published a review of 29 studies that found newer diabetes medicines work about the same as older, cheaper drugs.

Merck & Co.’s Januvia, approved in 2006, and Eli Lilly & Company’s Byetta, approved in 2005, were among those studied. The newer drugs are touted as more beneficial because they do not cause low blood sugar and can lead to weight loss.

But the published review found the newer diabetes drugs are no more effective than older medications available for nearly one-third of the cost. The newer drugs also cause new side effects such as nausea, vomiting, and infections.

For a one month’s supply, or 30 pills, of Januvia, consumers pay nearly $5.50 per pill. A one month’s supply of Byetta, given in an injectable cartridge, costs $200. But 60 pills of metformin, a generic drug for type 2 diabetes, costs $33.99, or about $1.76 a pill.

Researchers who found the newer drugs cause headaches, urinary-tract infections, and other side effects are concerned a patient’s immune-system function may be affected. This is significant for diabetes patients because they are more likely to develop a urinary-tract infection and are at an increased risk of complications.

Source: Michelle Fay Cortez, “Merck’s Januvia, Lilly’s Byetta work no better than older drugs,” Bloomberg.com, July 10, 2007.

On the same day the New England Journal of Medicine said the popular diabetes drug rosiglitazone, an ingredient in the diabetes drug Avandia, was linked to a greater risk of heart attack, a 60-year-old patient and user of the drug died of a heart attack. Now his wife and son are suing GlaxoSmithKline (GSK), the drug’s maker, saying it contributed to the man’s death.

Larry Alan Stanford had taken Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005. Now GSK is faced with what could be the first of many Avandia lawsuits or Avandamet lawsuits.

“I believe the evidence will show the company knew there were problems with Avandia, but decided to keep on selling it to Larry and others,” personal injury attorney Stephen Drinnon, who represents the Stanford family, said in a release dated June 20, 2007.

The New England Journal of Medicine said Avandia could raise a patient’s risk of heart attack by 40 percent. The drug linking Avandia and Avandamet is rosiglitazone, a drug the lawsuit against GSK says is deadly.

“Glaxo knew or should have known that its rosiglitazone drug greatly increased plaintiffs’ risks of having a heart attack and /or other negative cardiovascular consequences or of causing sudden cardiac death,” the lawsuit says.

Sources: “Avandia maker sued over heart attack,” Associated Press, June 20, 2007; “Glaxo failed to warn of diabetes drug risks: lawsuit,” Reuters, June 20, 2007.

On June 12, 2007, USA Today reported on a scientist from the U.S. Food and Drug Administration (FDA) who said her directors reprimanded her for recommending that Avandia get a “black box” warning about congestive heart failure.

Rosemary Johann-Liang, the former deputy director of the Division of Drug Risk Evaluation, said she recommended the Avandia warning on the suggestion of her staff. The FDA is investigating the validity of Johann-Liang’s claims.

In the meantime, the Senate Finance Committee is asking the FDA to make sure no scientist is reprimanded for raising safety questions.

“Those FDA employees dedicated to post-marketing surveillance…should be able to express their opinions in writing and independently without fear of retaliation, or reprimand or reprisal,” Sen. Chuck Grassley wrote in a letter dated June 4, 2007.

Johann-Liang said she wanted to be an advocate for drug safety, but oftentimes, her bosses did not want to hear about it.

“A lot of times the agency doesn’t want to hear that there are problems,” she said. “I think, in general, there is a culture of ‘The drug is always innocent.’”

Specifically Johann-Liang is warning people about Avandia, which she feels is a dangerous drug.

“People are continuing to be hurt,” she said. “Congestive heart failure is a very, very clear adverse reaction syndrome with Avandia.”

Source: Rita Rubin, USA Today, “FDA scientist says she was reprimanded for warning.” June 12, 2007.

At least two cases have been filed against GlaxoSmithKline PLC (GSK) about the company’s diabetes drug Avandia. The lawsuits allege that GSK caused patients to suffer heart attacks

Shareholders in GSK. also filed a lawsuit, claiming the company misled investors about the safety of the drug. The lawsuit seeks class-action status and alleges the company failed to acknowledge a link between Avandia and higher risk of heart attacks.

On May 29, 2007, Sharon Ann Dabon filed a suit against GSK claiming Avandia caused her to suffer injuries like heart injury and liver failure. Another case, filed June 1, 2007 by Benjamin Sarconi, claims Avandia caused a heart attack and congestive heart failure.

Some attorneys said the personal injury lawyers for those filing Avandia lawsuits may have difficulty proving the drug caused heart problems because diabetes itself increases a person’s risk for heart attacks.

Source: “Jeanne Whalen,” Shareholders sue Glaxo over Avandia disclosure,” Wall Street Journal, June 13, 2007.

While a jury in the Los Angeles County Superior Court deliberated a wrongful termination case on June 5, 2007, Wayman Wendell Cheatham settled with his former employer, MannKind Corp., out of court.

Cheatham alleged that MannKind, the maker of a new diabetes drug, Technosphere, withheld important information from the FDA during the drug’s trials. He did not suggest the drug is dangerous.

Cheatham claimed MannKind hid unexpected lab test results that showed Technosphere, a new inhaled form of insulin, demonstrated potentially more potency than expected. Cheatham said the company did not contact the FDA about the results.

While neither side would release the terms of the settlement, Cheatham’s suit sought $4 million in damages.

Sources: Daniel Yi, , “MannKind to settle lawsuit.” Los Angeles Times, June 6, 2007; Daniel Yi, “MannKind’s hopes rest with its inhaled insulin,” Los Angeles Times, May 21, 2007.

When Dr. John B. Buse testified at a U.S. Congressional hearing on June 6, 2007, he explained how a top executive at pharmaceutical giant GlaxoSmithKline (GSK) threatened him with a lawsuit because the doctor warned the public about Glaxo’s drug, Avandia.

Buse’s confrontation with GSK began in 1999, he said, when he told the U.S. Food and Drug Administration that Avandia raised the risk of chest pain and heart attacks by 50 percent. He said he was given 25 minutes to present two hours worth of research at that hearing.

After that hearing, Buse said “an executive,” later tabbed as Dr. Tadataka Yamada, the then-chief of research and development at SmithKline Beecham, called him a “liar” and a “scoundrel” for his research on Avandia.

According to Buse, the company went as far as suggesting to his boss that the doctor wanted to be paid off. Buse wrote in a letter to Yamada in 1999, in which he said “I was not upset when my chairman called me into his office to tell me that some in your company perceive me as being ‘for sale,’ as he knows me well enough to doubt it.”

In addition, GSK suggested Buse might be sued for lost profits. “The market capitalisation of the company had declined by $4 billion and there were people in the company who felt I might be liable for that,” he stated.

Representative John Yarmuth, Democrat from Kentucky, said in the June 6 hearing, “We cannot have a post-regulatory environment where manufacturers intimidate scientists.”

Sources: Stephanie Saul, “Doctor Says He Was Assailed for Challenging Drug’s Safety,” New York Times, June 7, 2007.

One day before a Congressional hearing to evaluate the safety of GlaxoSmithKline’s drug Avandia, the New England Journal of Medicine released early findings of a study called “RECORD,” which will not be finished until 2008.

The RECORD study is funded by Glaxo, and according to the Journal, it does not provide enough data to show whether Avandia is associated with a higher rate of heart attacks. The article comes in the midst of Cleveland Clinic cardiologist Steven Nissen’s research, also printed in the Journal, which tied the drug to a higher risk of heart attacks.

Specifically, the study followed 4,447 people with Type 2 diabetes for an average of 3.75 years. In the Avandia group 217 people died of cardiovascular causes, and in the non-Avandia group, 202 died from the same.

Despite the study being incomplete and the Journal’s analysis saying the study was inconclusive, Glaxo continued to suggest the drug is safe.

“Patients and physicians should find these data reassuring,” Moncef Slaui, the head of research and development at Glaxo, said in a statement.

Glaxo has blitzed newspapers across America with full page ads printing a letter from its chief medical officer, Dr. Ronald Krall. In the letter, Krall said “GlaxoSmithKline stands firmly behind Avandia.”

Source: Jeanne Whalen and Anna Wilde Mathews, “Analysis of Avandia Finds No Increased Risk of Death,” Wall Street Journal, June 6, 2007.

The U.S. Food and Drug Administration wants its most serious warning, a “black box,” printed on GlaxoSmithKline’s second-best selling drug, Avandia. The FDA made the request to GSK on May 23, and it informed the U.S. House of Representatives of the request at a June 6, 2007 hearing on Avandia’s potential health risks.

The black box would warn patients that Avandia increases the risks of congestive heart failure. Glaxo has not agreed to the request. The drug company makes $3 billion annually from Avandia sales.

The FDA has also asked for Avandia’s leading competitor, Actos, to carry a black box warning as well. The FDA has not issued an Avandia recall.

Concern in the House was that the FDA is not doing enough to protect consumers. The FDA is still investigating claims the drug causes heart attacks and chest pain. A similar warning or Avandia recall could follow. Nevertheless, some representatives are frustrated with the FDA’s apparent failure to take action.

“The FDA dropped the ball,” Rep. Henry Waxman, Democrat from California, said at the Congressional hearing.

Source: Sabine Vollmer, “FDA asks for stiff Avandia warning,” Raleigh News & Observer, June 7, 2007.

In 1999, University of North Carolina at Chapel Hill professor John Buse voiced his concerns about the safety of diabetes drug Avandia to its manufacturer, GlaxoSmithKline (GSK).

On June 6, 2007, Dr. Buse will testify at a congressional hearing about whether the company and the Food and Drug Administration (FDA) should have alerted the public about the potential risks associated with Avandia.

The hearing comes after a study conducted by cardiologist Steven Nissen was published in the New England Journal of Medicine that linked Avandia to a potential heart attack risk.

In addition to focusing on how GSK and the FDA handled the drug, the hearing will focus on whether Dr. Buse was intimated by GSK to silence his criticism of the drug. A letter to GSK from the Senate Finance Committee said investigators are looking into claims that GSK silenced medical professionals.

In March 2000, Dr. Buse sent a letter to the FDA saying Avandia may raise a patient’s risk of heart attack**. He also said that GSK manipulated the data from clinical trials to overstate the drug’s benefits and understate the drug’s risks.

GSK has not yet issued an Avandia recall.

Sources: Stephanie Saul, “Doctor says drug maker tried to quash his criticism of Avandia,” New York Times, June 2, 2007; Anna Wilde Mathews, “Diabetes expert to testify on Avandia,” New York Times, June 1, 2007.

On March 15, 2000, Director of the Diabetes Center at the University of North Carolina at Chapel Hill John Buse sent a letter to the U.S. Food and Drug Administration (FDA) voicing his concerns about Avandia’s safety.

In his letter, Dr. Buse outlined his concerns about the adverse cardiovascular effects of Avandia. He even said that he rarely prescribed the diabetes drug to his own patients.

Dr. Buse alleges that GlaxoSmithKline, then named SmithKline Beecham, rampantly abused clinical trial data. Dr. Buse goes so far as to say the company blatantly manipulated the data from trials to conceal information about the drug that may imply it is unsafe.

“I am sure there have been abuses by representatives of all companies that market drugs,” Buse wrote, “but there is something pervasive and systematic that I detect in my travels regarding the marketing of rosiglitazone,” the generic name for Avandia.

On May 21, 2007, a study published in the New England Journal of Medicine raised questions about the safety of Avandia Dr. Steven Nissen with the Cleveland Clinic analyzed 42 clinical trials involving the drug and concluded the drug increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent.

GlaxoSmithKline released a statement saying it “strongly disagreed” with both Buse’s statements and Nissen’s study. The company is now testing a11 other drugs in the same family as Avandia, all of which could be tainted if suspicions about the cardiovascular risks associated with them rise.

Analysts have drawn parallels between Avandia and Merck & Co.’s Vioxx, a painkiller recalled in 2006 after it was linked to heart attacks and deaths. The drug was recalled, causing a ripple effect relating to other, similar painkillers.

The FDA has not issued an Avandia recall.

Source: Chris Coletta, “UNC doctor warned FDA about Glaxo drug years ago,” Triangle Business Journal, May 23, 2007; Letter from John B. Buse to Food and Drug Administration, March 15, 2000; Sabine Vollmer, “GSK’s Avandia problem may grow,” New and Observer, May 25, 2007.

An analysis of GlaxoSmithKline’s diabetes drug Avandia published in the New England Journal of Medicine says elevated heart risks are associated with the medication, and members of Congress from both parties are voicing their concerns.

Representative Henry Waxman, D-California, chairman of the House Committee on Oversight and Government Reform, announced that a hearing has been scheduled for June 6, 2007 to discuss the role of the U.S. Food and Drug Administration (FDA).

Iowa Republican Charles Grassley has criticized the FDA for not responding more quickly or efficiently to concerns about the safety of Avandia.

“Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out,” Grassley said. “Tens of millions of prescriptions have been written for Avandia, and Medicare and Medicaid have paid hundreds of millions of dollars for this drug.”

Vioxx was a drug to relieve signs and symptoms of osteoarthritis, acute arthritis pain and painful menstruation. It was recalled on September 29, 2004 after a trial found that patients taking Vioxx were at a greater risk of sudden cardiac deaths. The drug was recalled from the market.

The FDA has received criticism for not studying the safety of Avandia. Agency officials said their evaluations of the drug provided conflicting data and did not prove the drug was dangerous.

GlaxoSmithKline has disputed the results of the new analysis. The company cited a similar review that found a 30 percent increased risk of heart problems associated with Avandia, but said the risk was not confirmed after additional studies.

The FDA said an advisory panel would be convened to discuss the safety of Avandia, but it did not plan to make any immediate changes to the current side effects warnings on the packaging of the drug.

Grassley also said that nearly five years ago the FDA’s safety office recommended that Avandia have the strongest possible warning, but the recommendation was overruled by other FDA offices.

“The FDA didn’t take that advice,” Grassley said. “Instead, the warning about congestive heart failure risks with this drug is currently buried.”

Grassley is the ranking Republican for the Senate Finance Committee, one of three congressional panels investigating the FDA’s management of Avandia. The FDA is also conducting a review.

Source: Marilynn Marchione, “Diabetes drug may raise risk of heart attack,” PressofAtlanticCity.com, May 22, 2007; Ricardo Alonso-Zaldivar, “Diabetes drug Avandia caused concern 5 years ago,” Star Tribune, May 23, 2007; Ricardo Alonso-Zaldivar, “Concerns about diabetes drug Avandia aren’t new,” LA Times, May 23, 2007.

On May 21, 2007, a study published by Dr. Steve Nissen in the New England Journal of Medicine alleged there is an increased risk of cardiovascular disease associated with the diabetes drug Avandia. The following are some questions and answers relating to the new study:

1. Who is Dr. Steve Nissen?

Steve Nissen is a cardiologist and chairman of cardiovascular medicine for the Cleveland Clinic, one of the most prestigious heart clinics in the United States. In 2001, he co-authored an analysis of Vioxx that found an increased risk of heart attack or stroke in patients. Merck recalled the drug in September 2004 after its own study confirmed the risk. Dr. Nissen also published an article in 2005 speaking about concerns he had with Pargluva, a diabetes drug that a Food and Drug Administration (FDA) panel supported. The FDA ultimately declined to approve the drug.

After his Pargluva study, Dr. Nissen received an email from a diabetes expert who suggested that Avandia undergo analysis as well. He began studying Avandia in 2006, initiating congressional investigations and researching previous studies published by GlaxoSmithKline. While researching, he found a study similar to the one he was conducting performed by GlaxoSmithKline. The study also showed slightly elevated risks of heart attacks, but the company wrote that these risks were manageable and no conclusion could be drawn from their study.

Dr. Nissen found, after conducting a meta-analysis of 42 previous studies, that Avandia shows a higher heart-attack risk, and a 64 percent elevated risk of death from cardiovascular causes like a heart attack or stroke.

2. GlaxoSmithKline performed a previous study of Avandia and said results were inconclusive. Do they agree with this new study?

GlaxoSmithKline has said it “strongly disagrees” with Dr. Nissen’s conclusions and assures its patients that it has full confidence in the safety of Avandia when used appropriately.

3. What is a meta analysis?

A meta analysis is a study that combines results from a group of previous studies that examine the same question. The purpose is to summarize all possible evidence relating to a specific issue or drug.

4. Should I stop taking Avandia?

A patient should never stop taking medication without first discussing it with a doctor. The FDA has advised patients taking Avandia to discuss cardiovascular risks with their doctors and to consider alternative therapies. In a joint statement with the FDA, the American Heart Association, American College of Cardiology, and American Diabetes Association said the overall risk associated with Avandia “appears to be small.”

5. I’m a diabetic. Should I be concerned about Dr. Nissen’s results?

If a diabetes patient is already taking a heart medication, the risk for a cardiovascular problem may be especially high. Cardiovascular disease is the leading cause of death in patients with diabetes and affects people with diabetes more than twice as often as other patients.

Patients taking Avandia are advised to speak with their doctors about the new drug information and about available treatment options.

6. When should I see my doctor?

Avandia may cause your body to hold extra fluid, which can lead to swelling and weight gain. The extra body fluid may cause some heart problems to worsen or may lead to heart failure. If you have any of the following symptoms, you should call your doctor immediately:

• Swelling or fluid retention
• Shortness of breath or trouble breathing
• An unusually rapid increase in weight
• Unusual tiredness
• Unexplained tiredness
• Stomach problems
• Dark urine
• Yellowing of skin
• Vision changes (rare)

7. Where can I find more information about Avandia?

For more information, consumers can visit GlaxoSmithKline’s Avandia website, or call GlaxoSmithKline’s Customer Response Center at 1-888-825-5249 between 8 a.m. and 8 p.m. Monday through Friday.

Sources: Anna Wilde Matthews, “Sequel for Vioxx critic: Attack on diabetes pill,” Wall Street Journal, May 22, 2007; Sarah Rubenstein, “What diabetes patients need to know,” Wall Street Journal, May 22, 2007; Food and Drug Administration Release P07-88, May 21, 2007; American Diabetes Association joint statement, May 21, 2007; GlaxoSmithKline, “Questions and Answers to Current Events about Avandia,” May 21, 2007.

On May 21, 2007, a study published in the New England Journal of Medicine raised questions about the safety of GlaxoSmithKline’s diabetes drug Avandia. Dr. Steven Nissen with the Cleveland Clinic analyzed 42 clinical trials involving the drug, known generically as rosiglitazone, and concluded that the drug increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent.

Avandia is widely used to treat type 2 diabetes by keeping blood sugar levels within a safe limit. Approved by the U.S. Food and Drug Administration (FDA) in 1999, Avandia has been prescribed to approximately 60 million patients.

Diabetic patients are especially susceptible to heart disease because diabetes can damage the heart muscle and advance the formation of potentially fatal blood clots.

“Cardiovascular disease is far and away the leading cause of death in diabetes,” Dr. Nisssen said. “If you find a diabetes drug increases the risk of heart attacks, the consequences are so grave that it warrants urgent action.”

The FDA has advised diabetes patients taking Avandia to discuss the new information with their doctors as well as possible alternative therapies. Patients should not stop taking any medications without first consulting their doctors.

The study’s findings are based on analysis of published data from previous clinical trials comparing the risk of heart attack and heart disease-related death in those who took Avandia with patients who took a placebo. The analysis, involving almost 28,000 patients in clinical trial studies that lasted between six months and one year, discovered that more than 65 percent of the deaths of patients in the drug trials could be attributed to heart disease. There were 158 heart attacks and 61 deaths from heart complications in the studies.

GlaxoSmithKline presented its own study of the drug to the FDA in August 2006, in which it found a cardiovascular risk of about 30 percent. This risk percentage, however, was not confirmed by long-term or observational studies.

Dr. Nissen is a cardiologist and chairman of cardiovascular medicine for the Cleveland Clinic, one of the most prestigious heart clinics in the United States. In 2001, he co-authored an analysis of Vioxx that found an increased risk of heart attack or stroke in patients. Merck recalled the drug in September 2004 after its own study confirmed the risk.

Dr. Nissen also published an article in 2005 speaking about concerns he had with Pargluva, a diabetes drug that a Food and Drug Administration (FDA) panel supported. The FDA ultimately declined to approve the drug.

After his Pargluva study, Dr. Nissen received an email from a diabetes expert who suggested that Avandia undergo analysis as well. He began studying Avandia in 2006, initiating congressional investigations and researching previous studies published by GlaxoSmithKline.

While researching, he found a study similar to the one he was conducting performed by GlaxoSmithKline. The study also showed slightly elevated risks of heart attacks, but the company wrote that these risks were manageable and no conclusion could be drawn from their study.

The Food and Drug Administration (FDA) has not confirmed that Avandia increases risks for heart death or disease.

For more information, consumers can visit GlaxoSmithKline’s Avandia website, or call GlaxoSmithKline’s Customer Response Center at 1-888-825-5249 between 8 a.m. and 8 p.m. Monday through Friday.

Sources: Julie Steenhuysen, “Glaxo’s Avandia raises heart-death risk: study,” Reuters, May 21, 2007; Stephanie Saul, “Study cites safety questions about diabetes drug,” New York Times, May 21, 2007; Michelle Fay Cortez, “Glaxo’s Avandia May Raise Heart-Attack, Death Risks,” Bloomberg.com, May 21.

GlaxoSmithKline PLC sent letters to U.S. physicians in February, 2007 warning that long-term use of Avandia, a drug used to treat diabetes, is linked to a higher risk of fractures in female patients. It is quite possible that a similar letter will go out to British physicians soon, as GlaxoSmithKline is currently engaged in talks with the European Union about the need for such communication.

The findings were a result of a double blind study called ADOPTS (A Diabetes Outcome and Progression Trial). ADOPTS looked at the efficacy of differing medications for treatment of type 2 diabetes the most common form of diabetes. The study examined 4,351 patients who were followed for at least a month. Researchers compared blood sugar control offered by different pharmaceuticals, including Avandia. Patients were randomly assigned to three separate treatment groups.

GlaxoSmithKline’s letter to physicians stated that most of the fractures documented in the women studied occurred in the upper arm, hand or foot. These sites of fracture differ from the sites of fracture noted in women who are post-menopausal and have osteoporosis, a population often experiences fractures. Post-menopausal women often have fractures in the hip and in the spine. The ADOPTS study results were published in the New England Journal of Medicine.

If you are using Avandia and have experienced a fracture, especially in the upper arm, hand or foot, consider reporting the event to the FDA MedWatch program at 1-800-332-1088.

Make a MedWatch report about Avandia right now.

Sources: “Glaxo Says Diabetes Drug Is Linked to Fracture Risk,” Wall Street Journal, February 22, 2007; GlaxoSmithKline Letter to Physicians, February 22, 2007.