FDA-Approved Doesn’t Mean Safe: 10 Dangerous Drugs Pulled By the FDA
America, time and time again you have been fooled. With every advertisement for the latest medication that touts the claim of “FDA-approved” you are lulled into a false sense of security and safety. We feel reassured when we take these medications by the fact that both the drug developers and the FDA’s team of scientists and doctors have put extensive research into assuring you that your medication is not only safe, but effective. Because that’s how the FDA works- isn’t it?
What Does it Take to Be “FDA Approved?”
Have you ever bothered to do your own research into what it takes to be ‘FDA-approved’? In the wake of the mid-January tragedy involving a French drug trial causing the death of one man and the hospitalization of five others, the entire world became a bit more curious about the goings on of a drug trial, questioning the ethical nature of human testing. While I am of the opinion that it is a vital step in the production of potentially life-saving medications, I too couldn’t help but wonder just how safe the whole process is. I decided to look into what it really means when drug companies slap the “FDA approved” label on their products.
What I found was a bit shocking- and definitely not what we have been lead to believe by the crafty salesmen of Big Pharma.
“[The] FDA is responsible for protecting the public health by regulating human and animal drugs, biologics, medical devices, food and animal feed, cosmetics, and products that emit radiation.”
Alright, sounds good thus far.
“But not all of these products undergo pre-market approval.”
“If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.”
Aha! Now that’s some very important terminology- intended use. That essentially clears the FDA of any accountability should adverse effects arise from misuse or abuse of the product- it’s how they get away with technically not being held responsible for the addictive medications which have crippled our communities.
So what happens when those two things collide? What happens when a product hits the shelves before it gets approved, but the benefits don’t outweigh the risks? We’ve seen it happen repeatedly across the years- the lawsuits and widespread recalls.
Here are 10 dangerous drugs pulled by the FDA:
How long was it on the market? 27 years
What was it for? Acne
Why was it recalled? Use increased the chance of birth defects, premature births, and miscarriages in pregnant women. It also increased the chance of suicidal tendencies with the added unpleasantness of inflammatory bowel disease. No thanks, I think I’d rather have a few pimples and blackheads.
How long was it on the market? 3 years
What was it for? Lowering cholesterol
Why was it recalled? It caused Rhabdomyolysis. What’s that? Oh, just your muscles breaking down and releasing myoglobin into your bloodstream, causing kidney failure. 31 people died in the US with a total of 52 worldwide. There were an additional 385 nonfatal cases, most of which required hospitalization.
Darvon & Darvocet
How long was it on the market? 55 years
What was it for? Pain relief (opioid-based)
Why was it recalled? We know opioids can be highly addictive, but that wasn’t the reason this drug was pulled from the market. High toxicity to the heart, causing serious damage caused the drug to be banned in the UK in 2005 (50 years after its introduction) but it remained on US shelves until 2010. In the18 years between 1981 and 1999 over 2,100 people died due to the drug.
How long was it on the market? half a year
What was it for? pain relief
Why was it recalled? This narcotic would slow or stop breathing in high doses, leading to comas or death. When taken with alcohol, the drug caused the rapid release of hydromorphone into the system which could be fatal.
How long was it on the market? 1 year
What was it for? Treatment of hypertension
Why was it recalled? Fatal interactions with over two dozen other drugs including common antibiotics, antihistamines, and cancer medications. It was also found to have no significant benefit to those using it as treatment for hypertension, making the risks involved with potential drug interactions unreasonable. Patients who switched to similar medications after taking Posicor also experienced an increased risk of going into shock within 12 hours of making the switch.
How long was it on the market? 7 years
What was it for? Severe nighttime heartburn associated with Gastroesophageal Reflux Disease
Why was it recalled? The drug caused over 270 cases of severe cardiac arrhythmia in just six years, 70 of which resulted in death. These conditions included ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation. Though it was banned in India in 2011, limited use still exists in Europe and the US and Canada use it for animal treatments.
PTZ & Metrazol
How long was it on the market? 48 years
What was it for? Convulsive therapies for schizophrenia and other psychiatric conditions
Why was it recalled? The intended use is questionable enough, but PTZ and Metrazol were pulled from the market for its tendency to cause uncontrollable seizures, which in turn caused pulled muscles, broken bones, and spinal fractures. These side effects were hardly rare or isolated occurrences- as many as 48 percent of patients.
How long was it on the market? 23 years
What was it for? Sedative and hypnotic purposes
Why was it recalled? No, before you say anything, the recall had nothing to do with Bill Cosby; but it was recalled due to the illegal activity associated with the drug in the 1970s and 80s. Used as a date rape drug, Quaaludes became a dangerous feature of the party scene and recently came back into public scrutiny with the allegations against Bill Cosby. Quaaludes are now a schedule 1 controlled substance in the US, much like heroin, LSD, Ecstasy, and GHB.
How long was it on the market? 3 years, three months
What was it for? Anti-inflammatory used to treat diabetes
Why was it recalled? 90 or more cases of liver failure led to this recall- 63 of those caused death. About 35,000 personal injury lawsuits have been filed against the drug’s manufacturer due to damage caused by its use.
How long was it on the market? 5 years, four months
What was it for? Pain relief (Nonsteroidal anti-inflammatory drug)
Why was it recalled? Prescribed to over 20 million people and endorsed by the likes of (then) Bruce Jenner and Dorothy Hamill, Vioxx increased the risk of heart attack and stroke . The drug was linked to over 27,00 heart attacks and sudden cardiac deaths in just four years.
Do you think the FDA should be more responsible when it comes to drug approval? Leave your opinion in the comments below!
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About the Author
Alexandrea Holder is a South Florida native working toward double Master’s degrees in Psychology and English. She finds the psychological aspects of addiction and mental illness fascinating, as both are prevalent in her family’s history. When not researching and spreading addiction awareness, Alexandrea enjoys sparring, artistic pursuits, and admiring puppies online.