FDA Drug Recalls Cause Safety Concerns

The FDA has a safety and regulatory structure in place however, given the recurrent FDA drug recall rate, there are some serious question marks about the safety of FDA approved drugs. All doctors are aware of the Hippocratic oath. This suggests that when healing someone from a state of sickness, one should do no harm. Studies have raised issues over the recurrent FDA drug recall rate. This has really put some question marks over how well this oath is being observed.

The USA is a country that prides itself on capital and free market ideals. However, there seems to be a line of possible criminal or medical neglect of consumers being crossed. We’ve seen this mentality in films like The Wolf Of Wall Street. This is one example of a clear pursuit of capital regardless of consequences.

In this short article, we will consider whether the relentless pursuit of revenue being prioritized over the welfare of everyday people. We will look at the evidence suggesting that the FDA is not acting on possible medical negligence, which may be making people ill.

Why Drug Recalls Occur

A drug recall is when a drug that has previously been shown to be safe, or given an approval, to put to the market is declared no longer safe to be on the market. This is because the drug, that has previously been approved, has demonstrated a risk of harm to the public.

Some historical drug recalls by the FDA include Tylenol, Atorvastatin, Mibefradil and Troglitazone. You may have never heard of these drugs. However, they were used by a consumer at some point in time to safeguard their wellbeing and were also marketed.

As is often the case with FDA and other drug approvals, the thoroughness of FDA or other testing hasn’t been strict enough from the beginning. This leads to drugs being on the market too early, without proper side effect testing.

Drugs can have harmful side effects that adversely affect the consumer, which then lead to the drug being completely pulled from the market. FDA approved drugs can sometimes have other issues too, like product safety and contamination concerns. These sorts of recalls are more to do with adherence to agreeable good manufacturing practices. These practices have been put in place to safeguard public health. This is because they are not fully aware of the total scope of the product they are consuming. They form an important part of protecting public welfare and safeguarding drug standards.

Some typical good manufacturing practices violations include lack of sterility or carcinogen contamination. Other recall reasons include failed drug dissolution or stability specifications. These are also very important factors for the normal activity and safety of prescribed medicinal drugs.

How Bad Is The FDA Drug Recall Rate

Given the current state of FDA drug recalls, it seems that the Hippocratic oath is not being followed in the extent that it is supposed to be. Both through not following good manufacturing practices and approving drugs that are actually not safe to use, only retracting them once there is a big enough sample size to obtain side effect information from. There is a clear problem with the FDA drug approval process, but how bad is this problem.

To give an idea as to how bad the FDA drug recall rate is, lets look at some studies covering the reasons and extent of drug recalls by The Food and Drug Administration.

Recent FDA Drug Recall Data

In a study covering 30 months, a total of 21,120 products were recalled and pulled off of the market as being unsafe for the public. Of these, 348 manufacturers were identified as having issues conforming to safety standards, provided a defective product or produced enough adverse reactions for a drug to be removed from the market.

This trend of FDA drug recalls is one that seems to be increasing. One study, reviewing the rate of FDA recalls, has suggested that over the counter medication recalls have increased in recent years. Largely due to customer complaints or FDA observations.

A couple of FDA reports show some alarming issues with the FDA approval process. In the first quarter of 2013 there were 107 drug recalls. That figure increased by 32% compared with the previous quarter. The average number of recall events in that year was also much higher. This increase continued into the next two quarters. In the years 2018 to 2023 the FDA drug recalls showed an increase on average. While there were some dips, they remained at about the same level.

A recent comparison was made between the European Union and US FDA of 25 years of post-approval regulatory actions. These actions included recalls. Their figures show that the European Union biopharmaceuticals regulatory action rate was far lower than that of the US FDA. There were 2067 post-approval regulatory actions in the EU and 2438 by the US FDA. This is all frightening data for the FDA to consider.

Vioxx FDA Recall

One concerning case study showing how loose the FDA drug approval system is involves a drug called Vioxx. Vioxx was initially marketed as an anti-inflammatory drug. This drug had to be recalled by the FDA after there were reports of serious harm to users.

This is just one case study, there are many other cases where drugs or pharmaceutical products are causing harm to users and therefore being approved without proper safety procedures.

Another case study involves angiotensin receptor blocker drugs or ARB drugs. Contamination has led to inclusions of potential cancer causing, or carcinogenic, substances in these commonly prescribed medications. Recalls have followed suit.

Another mentionable drug recall made by the FDA was of the drug Avandia. This was a drug that was first prescribed for the management of diabetes. Years later, clinical research on side effects discovered that this drug increased risk of death from cardiovascular effects by 64%. The FDA have estimated that 100,000 heart attacks, strokes and deaths had occurred in the USA because of this drug.

These are indicative of a drug discovery and development issue or failures to prevent the initial marketing of these drugs by the FDA. Again, these are only some of the many examples of drugs that had FDA approval and had to be pulled from the market.

This further highlights persistent issues within the active domain of the FDA, ignoring the consequences of approving drugs early and prioritizing profits over health.

FDA Drug Approval Concerns

One study citing FDA drug recall figures isolated big issues with reducing initial drug development and manufacturing risks to the public. They also pointed to assumed drug recall risk from the FDA as being a problem. They mention how there is particular carelessness during drug development and manufacturing that may need to be addressed in the future.

While the FDA can monitor the status of a drug after it has been released, this seems only protectionary if the approval of the drug could have been avoided in the first place. There are serious bioethical considerations here that could suggest mild medical neglect.

Summary

Recurrent FDA drug recalls over the years have raised alarming concerns about the safety of FDA approved drugs. One key tenet of modern medicine is the Hippocratic oath. This suggest that a physician or medical practitioner should do no harm. There is a clear profitability from medical drugs, however it is down to organizations like the FDA to regulate these properly. The USA prides itself on capital and free market ideals. However, considering the evidence here, there may be a degree of medical negligence.

Drugs become recalled when they are no longer justified as being safe. This is due to the potential risk of harm to the public. Many recalls occur because of a lack of thorough product testing from the beginning. This leads to a drug being on the market too early.

Reasons for FDA drug recalls include product safety and contamination concerns, harmful side effects, non-conformance to stability tests or violations of GMP standards. There are manufacturing principles there to protect the safety of the public. For example, chemical carcinogens can contaminate a drug.

While there are dips in some years, FDA drug recall rates are consistently elevated and increasing on average per year. This is a cause for concern. Many drugs like Vioxx, Tylenol, atorvastatin, mibefradil, troglitazone, angiotensin receptor blocker drugs and Avandia have been recalled. These are just some drugs that the FDA has had to recall, some of these have caused very serious harm to multiple people taking these medications.

Given the current state of FDA drug recalls, it seems that the Hippocratic oath is not being followed in the extent that it is supposed to be.

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