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.

Transvaginal Mesh: Never Tested?

Serious complications, loss of sexual pleasure, constant pain: a sad combination. Women who underwent vaginal placement of surgical mesh experience these losses daily, and wonder how this damaging procedure could have been recommended for them.

Our firm is at the forefront of Chicago attorneys aggressively pursuing compensation for victims of transvaginal mesh placement. Injuries from pelvic mesh result from failure of the medical device itself or medical error in implanting the device.

Sorting through accounts of the horrific damage done to women with implanted surgical mesh raises the pointed question of how this procedure was approved by the U.S. Food and Drug Administration (FDA).

In 2008, the FDA issued a public health notification that warned about these devices. In 2011, the FDA issued an update, noting that serious complications are not rare and that the benefits of the procedure are no greater than those of other less dangerous options available to treat pelvic organ prolapse (POP).

In May 2012, the non-profit organization Consumer Reports offered an in-depth article on dangerous medical devices. In discussing transvaginal mesh troubles, the authors detailed the entry of pelvic mesh kits onto the medical market by manufacturers claiming substantial equivalence to previously approved hernia repair kits.

Without recalling the product, the FDA ordered safety studies earlier this year. Since then, Johnson & Johnson subsidiary Ethicon has taken four mesh kits off the market.

In 2010 alone, about 100,000 women received surgical mesh to treat pelvic organ prolapse. The slipshod approval process that led to the unnecessary daily suffering of so many women must be changed — if not by regulation, then by litigation.  If you have suffered serious injury as a result of transvaginal mesh implantation, contact a personal injury attorney in our office to determine if you are eligible for compensation.

The Heart of the Matter — Side Effects of AF Medications

Arrhythmia is a condition in which the heart beats too quickly and irregularly. Atrial fibrillation (AF) is a type of arrhythmia that occurs when disorganized electrical signals cause the upper and lower chambers of the heart to contract or beat too quickly, or fibrillate.

According to the National Center for Biotechnology Information (NCBI), atrial fibrillation is the most common arrhythmia. It increases with age, and differs widely in presentation and severity.  If you have AF, what do you need to know?

The faulty electrical signals underlying AF are caused by both transient and chronic factors, including:

  • Coronary heart disease
  • High blood pressure
  • Drug interactions
  • Stimulants like caffeine
  • Sleep apnea
  • Chronic illnesses such as lung disease
  • Viral infections

With AF, blood pooling in the upper chambers of the heart can clot and lead to stroke. In many cases, a blood-thinning agent is prescribed to reduce that risk.

While the prevention of blood clots is important, established drug Coumadin (warfarin) and new drugs like Pradaxa (dabigatran) have high-risk side effects. With no medical antidote, Pradaxa can facilitate internal bleeding and massive fatal hemorrhaging. Recent disclosure of the dangers of blood thinning drugs has increased the medical and legal focus on patients injured or killed by these pharmaceutical compounds.

Atrial fibrillation poses risks, but so does its treatment. If you suffer from serious drug side effects from blood thinners, get to the heart of the matter with your doctor — and speak with a knowledgeable personal injury attorney.