OKC Blog: Defective Drugs FDA Recalls and Side Effects

Imagine the typical start to your day. You probably wake up to the familiar yet undesirable sound of your alarm and, if you’re like most of us, head to the kitchen to start a pot of coffee before you go about the rest of your morning routine. But when you walk into the kitchen to pour yourself a cup, you are not greeted with the wonderful aroma of freshly brewed coffee. You smell nothing. Then when you take of sip of your strong black coffee, it is completely and utterly tasteless. And you are forced to accept that the rest of your day and the days to come will continue on in this manner.

Sadly, there are several Americans who currently carrying out the rest of their lives in a tasteless, odorless world, and they all have one thing in common. That is, after catching a cold, they turned to Zicam to relieve their nasal symptoms. Dr. Charles Lee, medical officer at the FDA’s Center for Drug Evaluation and Research, states that the FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products. One such patient, 39-year-old Katie Rhodes, tells ABC news that her condition has been a major life adjustment. She says that it has greatly impacted her social life, being that she can no longer taste food or wine, as well as her enjoyment of even the most mundane experiences in life. Along with this detrimental effect on quality of life, developing anosmia after using Zicam can also pose life-threatening consequences. “People without the sense of smell may not be able to detect dangers, such as gas leaks or something burning in the house, and may not be able to tell if food is spoiled before eating," says Deborah Autor, director of the office of compliance at the Center for Drug Evaluation Research.

As of June 16, the FDA issued a warning for consumers to stop using three Zicam intranasal cold remedy products containing zinc after continuous reports of some users developing anosmia. The FDA first started receiving adverse event reports about Zicam in 1999, and in 2006 Matrixx paid $12 million to settle 340 lawsuits brought by consumers who claimed the zinc nasal gel adversely affected their sense of smell. In their warning, the FDA has given Matrixx 15 days to stop marketing the product and to come up with a plan for getting the product off the shelves. Since there were no requirements for over-the-counter product manufacturers to provide adverse event reports to the FDA up until 2007, the FDA has also asked Matrixx to hand over more than 800 reports that Autor believes all relate to anosmia associated with zinc-bearing Zicam products. If you believe you have suffered any ill effects after taking Zicam, you should consult your physician immediately and then seek legal counsel to determine whether you are entitled to compensation.

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