Understanding the Black Box Label on Your Meds

Whether by need or by choice, many Americans look for health in a bottle.  According to the Centers for Disease Prevention and Control (CDC), in any given month during the three-year period from 2005 to 2008, almost 50 percent of the population took at least one prescription drug. With the steady increase in prescription drug use since that time, the percentage has risen alarmingly.

The U.S. Food and Drug Administration (FDA) is a federal agency charged with safeguarding public health through the regulation of food, drugs, medical devices and other products affecting the physical well-being of Americans.

As part of regulating pharmaceuticals, the FDA oversees the labels affixed to prescription drug containers.  A boxed warning or black box is the strongest alert or warning used by the FDA. It indicates that a drug meets one of the following criteria:

  • Given the possibility of a serious, potentially fatal adverse reaction, the benefit of the drug must be weighed against the risk
  • The risk of a serious drug reaction can be reduced or prevented by proper use
  • The FDA concluded that the drug is safe only in restricted use

In 2007, the FDA announced a boxed warning on the thiazolidinedione category of drugs, including Avandia, Actos, and Duetact. While the 2007 warning addressed the risk of heart failure, the FDA added additional warnings about bladder cancer from Actos in 2011.

Physicians and patients should discuss side effects of newly prescribed medications, although that does not always happen. If the best health outcome for you comes from a bottle, make sure you read the label and understand your risks. If you are seriously injured as a result of prescription drug side effects, you may wish to contact a personal injury attorney at our office for more information about your right to compensation.

Pradaxa Product Liability Update

When introduced by German pharmaceutical manufacturer Boehringer Ingelheim, it was hoped the prescription drug Pradaxa would replace Coumadin, a popular blood-thinning product with a troubled history of serious side effects. Both drugs are prescribed to reduce the risk of stroke in patients with irregular heart rhythms. Unfortunately, however, hopes for Pradaxa as a replacement for Coumadin did not come to fruition.

According to the Food and Drug Administration (FDA), over 1.1 million prescriptions for Pradaxa (dabigatran), were filled between October 2010 and October 2011. However, in 2011 alone, the FDA received reports of around 3,700 adverse drug reactions to Pradaxa. More than 500 deaths were reportedly linked to it.

Approved for sale by the FDA in October 2010 and still on the market, Pradaxa is now the focus of large scale litigation.

As experienced personal injury attorneys in Chicago, our firm helps clients pursue their rights after injury caused by Pradaxa. In recent legal news, the Joint Panel on Multidistrict Litigation (JPML) entered an order consolidating current and future federally-filed Pradaxa cases in the Southern District of Illinois. In reviewing 21 federal cases, the JPML held that:

  • The actions concern common questions of fact
  • Centralization in Illinois serves both parties and witnesses
  • The actions share common allegations of severe bleeding caused by irreversible effects of the anticoagulant Pradaxa
  • Consolidation avoids duplicate discovery, and preserves the resources of  both the parties and the judiciary

Our Chicago personal injury attorneys represent individuals and families injured by Pradaxa.  If you have questions, contact our office about your injury.