What happens when a drug that you have been prescribed by your doctor has been recalled and nobody bothered to tell you?
You’re not alone. It’s a frequent occurrence, one that has a potential quality-of-life altering impact.
Every year dozens of pharmaceutical drugs are recalled because of numerous reasons but adverse side effects and contamination seem to be the most prevalent reasons.
Who’s minding the store? Why aren’t pharmacists and doctors paying attention? It’s quite possible they are not being alerted as the two notification systems – the FDA and MedWatch have a 20 to 40 percent failure rate.
According to a new study published in the Archives of Internal Medicine, the FDA fails to effectively report as many as 40 percent or more of all Class I drug recalls. And is it only the FDA’s responsibility or are the drug manufacturers at fault too?
Federal law does not require drug manufacturers to notify the public about drug recalls. Does that seem ethical? What is the drug manufacturer’s responsibility in all this? In some instances, a company discovers that one of its products is defective and recalls it entirely on its own. In other instances, the FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply.
How is the class drugs defined?
Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life-saving drug, or a defective artificial heart valve.
Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.
Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect; off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.
In this study, researchers from Brigham and Women’s Hospital in Boston counted all the drug recalls which happened between 2004 and 2011; identifying 1,700. Of the 1,700, 91 were Class I recalls. Researchers found the FDA’s official Recall Alert System only issued official alerts for 55 of the 91 Class I recalls, or, mathematically speaking — about 60 percent.
MedWatch which also issues recall alerts, sent out 18 of the remaining 36 recalls, but another 18 recalls were never noted or publicized by the FDA.
What’s the problem? Nobody wants to prescribe or dispense a dangerous drug. Can the Class I drugs be lost or overlooked in the noise of Class II and Class III drugs and medical devices, which have their own class system too.
Have you been seriously injured from a drug that was recalled and nobody bothered to tell you? Unfortunately, it happens and could be considered personal injury unsafe drug or product liability lawsuits.