Parker Waichman LLP

FDA Staff Cite Avandia Concerns, As Advisory Panel Prepares to Discuss Drug’s Fate

Avandia continues to raise safety concerns with staff at the Food & Drug Administration (FDA), according to a 756-page briefing posted on the agency’s Website. The documents were posted in advance of an advisory panel meeting next week that could help determine whether or not Avandia, known generically as rosiglitazone, will stay on the market. […]

<"https://www.yourlawyer.com/topics/overview/avandia">Avandia continues to raise safety concerns with staff at the Food & Drug Administration (FDA), according to a 756-page briefing posted on the agency’s Website. The documents were posted in advance of an advisory panel meeting next week that could help determine whether or not Avandia, known generically as rosiglitazone, will stay on the market.

According to The Wall Street Journal, one of the documents included in the posting is a memo discussing the RECORD trial, an Avandia study paid for by GlaxoSmithKline, the manufacturer of the controversial diabetes drug. RECORD, which involved 4,500 patients, compared Avandia to patients receiving other diabetes drugs, metformin and sulfonylurea, for an average of 5.5 years. Released in 2009, RECORD did not show an increased heart-attack risk that has been seen in some other Avandia studies.

According to the Journal, the memo included in the FDA briefing was written by Thomas Marciniak, a medical team leader in FDA’s division of cardiovascular and renal products. He writes that RECORD was “inadequately designed and conducted to provide any reassurance about the CV (cardiovasular safety) of rosiglitazone.” He goes on to write that the RECORD results “confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks, the Journal said.

In addition to the RECORD study, the FDA advisory panel scheduled to meet next week will also look at a study conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research. It found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. Graham’s study involved 227,500 patients, making it the largest to date, and found that patients who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.

According to The Wall Street Journal, the FDA advisory panel will be asked to vote on several actions the FDA could take in regards to Avandia. These include allowing the product to stay on the market or adding restrictions on the use of the product such as only allowing certain doctors to prescribe the medication. The meeting will take place over two days, and the vote will occur next Wednesday. While the FDA is not required to follow the advise of such panels, it usually does so.

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.

Last week, Dr. Stephen Nissan, who conducted that study, released a follow-up to it. The update looked at 56 clinical studies involving 35,500 patients, including RECORD, and found an increased heart attack risk of 28 percent. Without RECORD, the risk of heart attacks rose to 39 percent, according to study.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with heart attacks. The black box didn’t satisfy many Avandia critics, however, who continue to advocate that it be pulled from the market.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Denny Tang assisted my family in a major personal injury matter and got us a result we were satisfied with. Denny was a consummate professional and showed great patience and care in our case. We're grateful for his assistance.
Kareen M.
9 months ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value You guys are exceptional very professional and understanding I would recommend your to anyone who needs help navigating the legal system
Denise Brown
2 years ago
5 Star Reviews 150
Michele J has such a great personality and is very knowledgeable. She’s a great asset!!! The Long family is appreciative of her hard work on our case. I would surely recommend Parker Waichman to everyone I know.
Christipher Long
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038