Posts Tagged ‘Avandia rosiglitazone FDA Food and Drug heart attack cardiovascular restriction increased risk dangerous drug’

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:

1. 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).
2. Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
3. 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.

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,

1. 86 suffered heart attacks compared to 72 among patients not on the drug;
2. 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.

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:

1. 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).
2. Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
3. 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.

Click on the link below to view a copy of the 2007 study published in the New England Journal of Medicine which showed a link between Avandia and an increased risk in heart attacks.

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.

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.

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 Law Group, P.C.

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.