As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

• Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
• Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
• Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
• Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

• Failure to meet product specifications: 25%
• Deviations from current Good Manufacturing Practice (cGMP): 23.9%
• Sterility: 12%
• Mislabeling: 10.9%
• Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

• Software issue: 79
• Mislabeling issue: 43
• Quality issue: 36
• Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

• Deputy Hip Replacement
• Eliquis
• IVC Filter Injuries
• Lipitor
• NuvaRing
• Stryker Hip Defects
• Testosterone Replacement Therapy
• Transvaginal Mesh Defects
• Xarelto
• Zimmer Knee Defects

Other Important Facts to Know

• Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
• You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

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Sources

“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3

“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1