Avandia Heart Attack

Avandia Heart Attack

The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report that has been released.

The 334-page report by the Senate Finance Committee also criticized the Food and Drug Administration, saying that the federal agency that regulates food, tobacco and medications overlooked or overrode safety concerns found by its staff.

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them,” said U.S. Senator Max Baucus, a Democrat and committee chairman. “Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.”

The bipartisan report also was signed by Sen. Chuck Grassley, the top-ranking Republican on the committee.

GlaxoSmithKline rejected any assertions that the drug is not safe.

“We disagree with the conclusions in the report,” company spokeswoman Nancy Pekarek told CNN. “The FDA had reviewed the data and concluded that the drug should be on the market.”

Seven clinical trials on the drug prove that it is not linked to heart attacks, Pekarek said.

“None of that data shows a statistically significant correlation between Avandia and myocardial ischemia or myocardial infarction [heart attack],” she said.

Ischemia is a condition in which blood flow and oxygen are blocked from going to certain parts of the body.

The Senate committee investigation stems from concerns that Avandia and other high-profile drugs put “public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks,” the report states.

FDA Commissioner Margaret Hamburg said she is waiting for the recommendations of an advisory committee that will hear reports on the drug this summer.

“Meanwhile,” Hamburg said in a statement, “I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

Although the FDA has not yet mandated a recall, in its latest press release the agency recognized that Avandia does, in fact, increase the risk of heart attack and stroke. Indeed, the FDA has acknowledged that by 2007 more than 83,000 Avandia heart attack victims had experienced this severe cardiovascular event as a direct result of the drug’s serious side effects.

Avandia Heart Attack: RECORD Study

The RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study results were submitted to the FDA in August 2009. They indicated that Avandia patients are twice as likely as control subjects to suffer congestive heart failure. The study included diabetes patients between the ages of 40 and 75 with a body mass index of more than 25.

Avandia Heart Attack Symptoms

If you or a loved one is experiencing the following symptoms while using Avandia, please consult a medical professional immediately or call 911:

  • Chest discomfort/pain
  • Discomfort in upper body areas: arms, back, neck, jaw and stomach
  • Shortness of breath
  • Sweating, nausea and lightheadedness
  • High blood pressure
  • Fluid in the lungs

How Does Avandia Increase the Risk of Heart Failure/Stroke?

Although critics argue that there is no direct evidence on the mechanism by which Avandia leads to heart attacks, the latest FDA safety report indicates that Avandia may have an adverse effect on several body functions that lead to heart attack and stroke. Specifically, Avandia may:

  • Affect serum levels (cholesterol)
  • Increase the heart’s demand for oxygen
  • Lower hemoglobin — iron-rich protein found in red blood cells
  • Increase psychological stress

All of the above symptoms may lead to an increased risk of myocardial ischemia, heart attack or heart failure. Avandia stroke victims may also suffer their serious illness as a result of these symptoms.

If you feel that you or a loved one may have an Avandia Heart Attack Claim, please fill out the form to the right and we will have an experienced Avandia Attorney contact you to discuss your options.