Avandia Controversy Renews Calls for FDA Reform

After the Food and Drug Administration (FDA) delayed taking action regarding the diabetes drug Avandia, many are calling on the federal agency to remove the drug from the market.

Safety of Diabetic Drug Up for Second Review

Avandia was first approved for treatment of Type-2 diabetes in 1999. Concerns about the drug's safety and link to heart attacks were raised at least six years ago, but the FDA failed to warn the public of these risks.

In 2007, a study conducted by the Cleveland Clinic and published in the New England Journal of Medicine found that the drug increased the risk of heart attacks by 43% and the risk of cardiovascular death by 64%.

Based on the recommendations of an expert panel, the FDA decided not to remove Avandia from the market at that time, but instead issued a black box warning about the drug's increased risk of heart attacks, which are the number one killer of diabetic patients.

Now, new safety concerns surface again regarding Avandia. These concerns include allegations that the drug's manufacturer, GlaxoSmithKline, withheld data that showed problems with the drug, and failed to adequately warn users of the potentially life-threatening side effects. Evidence also proves that the FDA's internal staff warned of the increased risk of cardiovascular problems associated with Avandia's use, but were ignored.

GlaxoSmithKline continues to maintain that Avandia is safe for use and should not be removed from the market.

Lack of Autonomy, Infrastructure Causes Delay in FDA Action

The criticisms of the FDA's inability to quickly identify safety risks and take action to remove dangerous drugs from the market began long before the current controversy over Avandia. In fact, the agency was similarly criticized for failing to timely remove the prescription painkiller Vioxx from the market, which eventually was pulled in 2004 for its link to heart attacks.

Critics have pointed out that the FDA's current procedure is a major factor preventing the agency from acting efficiently if a problem in a newly released drug has been detected.

Currently, the FDA's Office of Surveillance and Epidemiology is responsible for keeping track of the potentially harmful side effects of drugs once they are released on the market. If this office detects a problem, the next step in the procedure is to report the issue to the Center for Drug Evaluation and Research, which happens to also be the department in charge of initially testing new drugs prior to receiving FDA approval.

It stands to reason that a conflict of interest may exist when the department in charge of the initial evaluation is the same department in charge of determining whether a drug it approved for release is dangerous enough to require a black box warning and/or removal.

Some argue that providing the Office of Surveillance and Epidemiology with a measure of autonomy in its decision-making process is vital. And if the department determines there is a potentially life-threatening risk with a newly approved medication, this information should be forwarded directly to the FDA Commissioner to ensure swift action is taken rather than funnel the information through the various levels of agency bureaucracy.

For its part, the current FDA Commissioner Margaret Hamburg promised in March 2010 to evaluate how the agency's procedures impact its ability to make decisions. However, the FDA has not made any recent moves to change its current operational structure.

Dangerous Drugs and the Manufacturer's Responsibility

Drug manufacturers have a duty to ensure that their products are safe for public use. If the drug has known side effects or other potential dangers, then the manufacturer must adequately warn the public about these risks.

Manufacturers of prescription drugs are required to provide not just adequate warning of the potential dangers that may occur from using their product, but timely warning. In other words, if a side effect does not become known until after the medication has been available for a few years, the manufacturer still must warn the public about the danger even though it did not exist at the time the drug initially was approved.

Drug manufacturers also have a duty to warn of potential side effects even in cases when the risk potentially may only affect a small number of those using the medication.

Regardless of the timeframe, size or nature of the potential harm or group affected, prescription drug manufacturers have a continuing duty to warn the public, even once the drug receives FDA approval.

Your Legal Rights

When a drug manufacturer fails to provide adequate warnings to consumers about risks associated with its product's use, the company may be liable for harm that results. In these cases, an injured party can file a products liability claim against the manufacturer, distributor, seller or other party in the "chain of distribution" responsible for the defective product, and seek monetary compensation for current and future medical expenses and lost wages. In cases when a person dies from using a defective drug, the person's family may bring a wrongful death action against the manufacturer.

If you have been harmed from using Avandia or another dangerous prescription drug, contact an experienced prescription drug claims attorney to learn more about your legal options.

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