The New England Journal of Medicine has published a Mayo Clinic study that tried to determine if doctors were aware of FDA warnings regarding potentially dangerous drugs. The study used Avandia, a controversial diabetes drug. Avandia is considered to be a good drug to look at for this study because in 2007, following a report published in the New England Journal of Medicine, the FDA required that Avandia come with a “black-box warning” — the strongest warning possible — alerting consumers that the drug was associated with an increased risk of heart attack. Then, in September of 2010, the scrutiny over Avandia intensified further when it was banned in Europe and all but banned by the FDA in America.
The concern with Avandia is that it may increase a 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. In addition, there are other concerns about the side effects of Avandia and two other drugs manufactured by GSK, Avandamet and Avandaryl including an increased risks of fractures of the upper arm, hand, and foot of women taking it.
Other reported side effects from taking Avandia include:
- Heart Attacks
- Congestive Heart Failure
- PPH – Primary Pulmonary Hypertension
- Bone Fractures
- Liver Failure
The Mayo Clinic study specifically looked at the impact black-box warnings for drugs have at a national level, and, more specifically, at a geographical level, and how these warnings are incorporated into practice. The Mayo Clinic study found that doctors’ prescribing patterns vary across the country in response to warnings about medications from the U.S. Food and Drug Administration. The result is that patients may be exposed to different levels of risk depending on where they live.
USAGE VARIED BEFORE AND AFTER THE BLACK BOX WARNING
The study found that there was a significant difference in usage of Avandia both before and after the imposition of the black box warning.
USAGE BEFORE THE BLACK BOX WARNING
Before the black box warning in 2007 Avandia was widely prescribed across the country, but there were still regional difference in use:
In Oklahoma, Avandia was prescribed about 15.5% of the time.
In North Dakota, Avandia was prescribed about 8% of the time.
USUAGE AFTER THE BLACK BOX WARNING
After the 2007 black box warning was required, the use of Avandia dropped dramatically, but there was still a significant amount of use of the drug, and the use of the drug varied regionally. Following the requirement of the black box warning, Avandia prescriptions dropped nationally 1.3 million monthly prescriptions in January 2007 to approximately 317,000 monthly prescriptions in June 2009.
In Oklahoma, Avandia use dropped to about 5.6 percent.
In North Dakota it tumbled to 1.9 percent.
EXPLANATION OF THE STUDY’S FINDINGS
The reasons for the differences aren’t clear, but researchers believe that the explanation for the different usage patterns are due in part to:
How doctors are made aware of FDA warnings and how they react.
The policies of state health insurance plans, including Medicaid, in terms of whether or not the drug is covered under state plans; and
Marketing by the drug-company.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
If you were prescribed the diabetes drug Avandia® and after taking Avandia® you suffered a heart attack or stroke then you may be eligible for compensation. Heart Attacks and Strokes have been identified as Avandia® Side Effects. In addition, if you have suffered other side effects associated with taking Avandia®, you should contact an attorney to discuss your rights. You may be entitled to compensation.
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;
- 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 Law Group, P.C.
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