Avandia
EUROPEAN REGULATORS BAN THE SALE OF AVANDIA | Dallas, Texas Personal Injury Attorney Blog
Avandia has been taken off of the market in Europe. European regulators say that the risk of heart attack associated with Avandia is too great a safety concern to continue its use for most people.
In simultaneous news briefings Thursday, the European Medicines Agency and the U.S. Food and Drug Administration announced their long-awaited decisions on the fate of GlaxoSmithKline’s controversial drug. The European regulator said it would stop authorizing marketing of Avandia, which will be off the market within the next few months.
The FDA said new patients will be able to get a prescription for Avandia, but only if they can’t control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks. FDA expects the restricted plan “will limit use of Avandia significantly.”
“Although the European Medicines Agency went further by actually suspended marketing of the drug, both regulatory decisions result in essentially the same outcome, virtually complete elimination of the use of this drug by patients around the world,” said Dr. Steve Nissen of the Cleveland Clinic. Nissen, who published the first paper linking Avandia to heart risks, said only a small number of U.S. patients would receive the drug under the new restrictions.
GlaxoSmithKline’s chief medical officer, Dr. Ellen Strahlman, said in a statement that the company will voluntarily stop promoting Avandia in all countries where it operates.
“As a matter of prudence we are restricting access,” said the FDA’s Dr. Janet Woodcock. “We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it is valid.”
The European Commission still must approve the recommendations by the European Medicines Agency, a process that could take several weeks. Decisions by the health regulators usually are not challenged. “In light of all the information available and including results from some very recent studies, the committee concluded that as of today, the benefits of rosiglitazone can no longer be considered to outweigh its risks,” Dr. Hans-Georg Eichler, EMA’s senior medical officer, said Thursday.
FDA Commissioner Margaret Hamburg said the FDA’s decision reflects its unique powers to restrict access to medications. While pulling a drug off the market is an extremely rare event in the U.S., it is more common in Europe, where drugs are approved on a conditional basis. “We are taking somewhat different strategies, but both strategies are designed to assure the goals of safety and effectiveness,” Hamburg said in a briefing with reporters. The FDA’s decision on Avandia is likely to draw ire from safety advocates and U.S. lawmakers, though it essentially concurs with the opinion outside experts reached earlier this year. In July, a 33-member panel of medical experts voted 20-12 to keep Avandia available in the U.S. Of the 20 who voted to keep it on the market, 10 said it should only be available on a limited basis. The FDA is not required to follow the group’s advice, though it often does.
The FDA has confirmed that studies show that Avandia® increases a patients’ risk of suffering a heart attack by 43% and cardiac-related death by 64%. These Avandia® side effects may not have been adequately disclosed by the manufacturer and an Avandia® Recall has yet to materialize. In addition to the risk of heart attacks and stroke, there are other concerns about Avandia including an increased risk of:
- Congestive Heart Failure
- PPH – Primary Pulmonary Hypertension
- Bone Fractures
- Blindness
- Liver Failure
- Hepatitis
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery;
- Loss of earnings and/or earning capacity, and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Herald Law Group, L.L.P.
Attorneys: Rachel Montes and Tom Herald
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
DEPARTMENT OF JUSTICE SUBPOENAS DOCUMENTS FROM GLAXOSMITHKLINE OVER ITS MARKETING OF AVANDIA | Dallas, Texas Personal Injury Attorney Blog
Avandia Angst: GlaxoSmithKline said it is responding to a U.S. Department of Justice subpoena and also to civil investigative demands” from “a number” of state attorneys general dealing with how the company developed and marketed the diabetes drug Avandia, the WSJ reports. (Its not clear whether the DOJ’s request relates to a civil or criminal probe.)
The disclosure came in GSK’s third-quarter earnings announcement, which showed a 3.5% drop in net profit. In September the FDA put additional restrictions on the use of the drug, while European regulators pulled it from the market.
Montes Law Group, P.C.
Attorneys: Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
AVANDIA WARNING | Dallas, Texas Personal Injury Attorney Blog
The US Food & Drug Administration (FDA) issues a consumer warning for persons who use any of the following products
• Avandia – (generic name – rosiglitazone maleate)
• Avandamet – Contains Avandia combined with metformin
• Avandaryl – Contains Avandia combined with glimepiride
• Actos – (pioglitazone HCl) is a type of oral diabetes agents called thiazolidinediones
Glaxo SmithKline manufactures the Avandia drugs and sells them under various generic names including Rosiglitazone Maleate. The drug is currently on the market and is used to treat Type II diabetes. The drugs may cause serious and deadly side effects that the manufacturer failed to warn patients or doctors of including:
• Death
• Heart Attacks
• Congestive Heart Failure
• PPH – Primary Pulmonary Hypertension
• Bone Fractures
• Hepatitis
These dangerous drugs have been on the market since 1999. Even though Glaxo knew of the problems, they failed to provide sufficient warning to the public or to the doctors that prescribed the medication. Avandia can cause heart attacks, Primary Pulmonary Hypertension (PPH), and Congestive Heart Failure in patients taking the drug.
If you have taken Avandia to help treat diabetes and have suffered one or more heart attacks or had symptoms of Pulmonary Hypertension or Congestive Heart Failure, or if you have been diagnosed with either of these serious conditions, call us today. There is a good chance you have been injured by Avandia. You need to get expert medical care and legal advice as soon as possible regarding your claim.
Avandia is sometimes combined with other diabetic medications into a single pill:
When your doctor prescribes one of these two combinations, the medication will have a different label but still contain Avandia.
If you have taken Actos, Avandia, Avandamet or Avandaryl and experienced one or more heart attacks, symptoms of Pulmonary Hypertension, or Congestive Heart Failure, or if your doctor has already diagnosed you with any of these conditions then call us today. Acting now could help save your life.
The diabetes drug Avandia has been associated with a significantly higher incidence of heart attacks and death, according to a major research analysis. The findings were the result of an analysis of 42 studies involving 15,560 patients who took Avandia and 12,283 who took other drugs or were given a placebo. The study was conducted by doctors at the renowned Cleveland Clinic and reported May 21, 2007 in The New England Journal of Medicine.
One of those who conducted the latest study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said it raised “serious concerns about the cardiovascular safety” of Avandia. (He advised that patients first consult with their doctor before discontinuing use of the medication.) Following release of the study, termed a “meta-analysis,” the U.S. Food and Drug Administration issued the following warning: “Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” The FDA said its own analysis of the drug was ongoing.
Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales in excess of $3 billion. The FDA approved it for use in 1999 for the treatment of Type 2 diabetes, the most common form of diabetes. Since that time more than six million people worldwide have taken Avandia.
Montes Herald Law Group, L.L.P.
Rachel Montes and Tom Herald
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
AVANDIA LINKED TO INCREASED RISK OF HEART ATTACK AND DEATH | Dallas, Texas Personal Injury Attorney Blog
On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
According to the New York Times, experts claim that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia was linked to 304 deaths during the third quarter of 2009 alone.
Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA issued her memorandum finding:
- The drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE).
- Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
- There is a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies.
As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
Avandia, a drug manufactured by GlaxoSmithKline’s (GSK), has been widely prescribed drug used to treat type 2 diabetes, has been shown to increase users’ risk of heart attack by 43 percent and cardiac-related death by 64 percent, according to the 2007 study published in the New England Journal of Medicine.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment; and
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity; and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Law Group, P.C.
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Fax: (214) 522-9428
Facebook @ Montes Law Group, P.C.
A LOOK BACK AT FDA ACTIONS CONCERNING AVANDIA | Dallas, Texas Personal Injury Attorney Blog
2007 NEW ENGLAND JOURNAL OF MEDICINE ARTICLE
After a 2007 study published in the New England Journal of Medicine showed a link between Avandia and an increased risk in heart attacks, on May 21, 2007, the Food and Drug Administration (FDA) issued a safety alert on May 21, 2007. However, the FDA did not ban the drug at that time or recommend that physicians take their patients off Avandia at that time, but instead promised a further investigation into the medication.
The study was conducted by two doctors at the Cleveland Clinic who evaluated 42 studies that compared patients taking Avandia with those who were not. The overall study involved 28,000 patients, 15,560 of whom were taking Avandia.
Of those patients taking Avandia,
- 86 suffered heart attacks compared to 72 among patients not on the drug;
- Another 39 patients died from cardiovascular causes compared to 22 patients who were not taking Avandia.
2007 BLACK BOX WARNING REQUIRED
In 2007, Seven Galson, the physician director of the FDA’s Center for Drug Evaluation and Research, announced that the FDA would analyze the information it has on the Avandia risk as soon as possible and make the results available. The FDA would also present the issue of Avandia’s potential heart attack side effect and the need for an Avandia warning or other action to an advisory committee as soon as one can be convened. Eventually, the FDA required a “black box warning,” the FDA’s most serious level of warning, for the increased risk of coronary problems in patients taking Avandia. In July of, 2007, the FDA announced that the manufacturer of Avandia (rosiglitazone) has agreed to add new information about potential increased risk for heart attacks to the existing boxed warning.
CONGRESSIONAL INVESTIGATIONS
Members of Congress have also expressed concern about the FDA handling of Avandia. Both houses of Congress are currently debating funding bills for the FDA that contain certain requirements for reform of the methods used by the FDA to monitor drug safety. Representatives John Dongell and Bart Stupac, both Democrats from Michigan, have vowed to investigate further whether GSK revealed the dangers of Avandia to the public. The House Oversight Committee held a hearing on the FDA’s handling of Avandia.
OTHER CONCERNS REGARDING AVANDIA
Another 2007 study raised additional concerns about Avandia side effects. The study found that Avandia increases the risks of fractures of the upper arm, hand, and foot of women taking it and two other drugs manufactured by GSK, Avandamet and Avandaryl. Since millions of people take this drug, bone deteriorization could have a major health impact.
SEPTEMBER 23, 2010: FDA ANNOUNCES SIGNIFICANT RESTRICTIONS
On September 22, 2010, Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA issued her memorandum finding that the drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE). The FDA noted that pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia. The FDA also noted that there is even a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies. As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity; and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Herald Law Group, L.L.P.
Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
SEPTEMBER 23, 2010: FDA REPORT RESTRICTING ACCESS TO AVANDIA | Dallas, Texas Personal Injury Attorney Blog
Attached is a copy of the Memorandum written by Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA concerning Avandai
(rosiglitazone) in which the FDA finds:
- the drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE).
- Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
- There is a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies.
As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Herald Law Group, L.L.P.
Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.