Contaminants such as carcinogens, trash, and bacteria are finding their way into FDA-endorsed pharmaceuticals
In the United States, approximately 4,500 drugs and medical devices are recalled annually, despite FDA approval and widespread use [1]. These recalls are initiated when products pose risks such as contamination, potential illness, injury, or consumer deception.
One such case is that of Anderson Moreno, a three-year-old boy who suffered a stroke in 2018 due to a contaminated stool softener [2]. The contamination led to Anderson's respiratory tract and lungs being infected, and he has been on a ventilator since then [3].
The contaminated stool softener contained Burkholderia cepacia, a bacteria that can cause infections in the lungs, bloodstream, and urinary tract [4]. This incident serves as a stark reminder of the risks associated with contaminated drugs, even those that have passed FDA inspections.
The incident in December 2015 involved employees at Nippon Fine Chemical in Japan barring an FDA inspector's access to their quality control laboratory [5]. This incident, while not directly linked to Anderson Moreno's case, highlights the challenges faced by the FDA in ensuring the safety of drugs.
Recalls can still occur after inspections due to evolving risk detection, reliance on manufacturers to initiate recalls, and limitations of inspection scope [1][4]. Common circumstances for recalls despite inspections include the detection of contamination, manufacturer self-reports or consumer/whistleblower complaints, FDA evaluations of adverse event reports, and voluntary recalls by manufacturers aiming to mitigate risk and regulatory consequences [1][4].
The FDA website provides information on current recalls, market withdrawals, and safety alerts. It is crucial for consumers to stay informed and vigilant about the products they use, especially those related to their health.
In light of cases like Anderson Moreno's, S. Bryn Austin, a professor of behavioral sciences at Harvard T.H. Chan School of Public Health, emphasises the need for consumers to be leery of supplements, as they could be putting themselves at risk [6]. Clinical drug trials are often paid for by pharmaceutical companies, which may explain the focus on supplements with missing ingredients rather than incidents like Anderson Moreno's.
In conclusion, while the FDA works diligently to ensure the safety of drugs and medical devices, recalls continue to occur due to various reasons. It is essential for consumers to stay informed and vigilant about the products they use, especially those related to their health.
References:
[1] FDA (2018). FDA Recalls, Market Withdrawals, & Safety Alerts. [online] Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
[2] Business Insider (2018). A toddler was given a contaminated stool softener that led to a stroke and put him on a ventilator. [online] Available at: https://www.businessinsider.com/toddler-given-contaminated-stool-softener-led-to-stroke-ventilator-2018-7
[3] CBS News (2018). Toddler taken off heart transplant list after contaminated stool softener leads to infection. [online] Available at: https://www.cbsnews.com/news/toddler-taken-off-heart-transplant-list-after-contaminated-stool-softener-leads-to-infection/
[4] Mayo Clinic (2021). Burkholderia cepacia. [online] Available at: https://www.mayoclinic.org/diseases-conditions/burkholderia-cepacia/symptoms-causes/syc-20355076
[5] FDA (2015). Warning Letters and Notices of Violation. [online] Available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters-and-notices-violation/japan-nippon-fine-chemical-co-ltd-warning-letter-12162015
[6] Harvard T.H. Chan School of Public Health (2019). Supplements: What You Need to Know. [online] Available at: https://www.hsph.harvard.edu/nutritionsource/what-should-you-know/supplements-what-you-need-to-know/
[7] Business Insider (2018). Natural supplements are a $40 billion industry. Here's why the FDA is warning that they could be harmful. [online] Available at: https://www.businessinsider.com/natural-supplements-a-40-billion-industry-fdas-warning-they-could-be-harmful-2018-6
- The case of Anderson Moreno, a three-year-old boy who suffered a stroke due to a contaminated stool softener, serves as a warning about the potential risks associated with contaminated drugs, even those that have passed FDA inspections.
- The incident highlights the importance of consumers staying informed and vigilant about the products they use, particularly those related to health and wellness, such as supplements.
- In light of cases like Anderson Moreno's, it is essential to pursue nutrition and health-and-wellness practices that prioritize whole, unprocessed foods and drinks, rather than relying on supplements that may be contaminated or lack appropriate ingredients.
- Beyond the FDA's diligent efforts to ensure the safety of drugs and medical devices, therapies, and treatments, consumers must acknowledge their role in maintaining their health by being aware of the products they consume and staying informed about current recalls and safety alerts.
- The science behind understanding and mitigating medical-conditions, including cancer, must prioritize evidence-based practices and demand transparency from both the pharmaceutical industry and the FDA to ensure the safety and efficacy of the therapeutic options available to consumers.
