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

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LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA