Data released for 2014 revealed a disturbing trend over recent years in the recall of medications and medical devices. The 1,225 recalls issued in 2013 set a record and 2014 was already positioned to break it before the month of August. With so many recalls being initiated, we have to ask why the medicines and treatments are being allowed to make it to market so quickly without solid evidence of efficacy and safety. Production procedures have also come under the microscope, with many recalls initiated due to unsafe manufacturing practices and contamination of products.
Ten Year Trend is Cause for Outrage and Dismay
In 2004, there were 166 drug recalls issued by the FDA. In only the first seven months of 2014, we witnessed 836 recalls. This is staggering and worth a long discussion on the causes of these recalls and why they are becoming so frequent. The public has the right to demand that medications be deemed safe using substantive research and trials in order to ensure their safety and to provide the information we all need to make informed choices about our health.
There are three drug classes the FDA uses to determine the risks that are associated with any given medicine or procedure. Here they are along with their definitions.
- Class I Recalls— this class is defined by a reasonable risk that patients may suffer serious health complications or death if they continue to take a medication.
- Class II Recalls— these recalls are for drugs that pose serious complications, but the nature of the complications are less severe and more correctable through medical intervention.
- Class III Recalls— these medications are recalled for other reasons and do not pose a significant risk of serious side effects or death.
The number of recalls is rocketing on a yearly basis and the vast majority of recalls are for Class II medications. 84% of the medicines recalled in 2013 were Class II meds. In 2013 and 2014, there were more recalls of Class II medications than in the prior nine year span combined.
What is the Cause of the Recall Surge?
In addition to the possible side effects and complications that medicines rushed to market may cause, some researchers have found that manufacturing practices are also a driver of drug recalls. In 2012, 60 people died from a breakout of fungal meningitis that was traced back to a pharmaceutical production facility. It is becoming more and more common for drug manufacturers to cut corners when producing their medications and this can pose a serious health concern because medications that were once deemed safe could have the potential to cause significant harm.
Since one production facility may be manufacturing numerous medications, the contamination of that facility, or poor production practices may result in the simultaneous recall of large quantities of medications. It also shows that the FDA is stretched far too thin and unable to properly protect the public. There are simply not enough men and resources for the agency to adequately monitor and police large pharmaceuticals and to make sure that they are producing products that are safe and effective.
The best way to protect yourself is to understand what the probable side effects are whenever you take any medication and to immediately seek medical attention if you experience an adverse reaction. Most people don’t believe that drug reactions or interactions can happen to them and we need to be more vigilant whenever we require any form of medication. While medicines have the power to cure our ailments, they always come at a price and we need to consider whether the benefits outweigh the risks.