40 Medications That Forced the FDA to Take Action
Fen-Phen promised to help people effortlessly shed pounds, but it did more than that. Fen-Phen was pulled from the market quickly after research showed that 30% of patients who took the drug had abnormal echocardiograms. Sometimes, patients would even have to undergo heart valve surgery to repair issues caused by Fen-Phen.
Palladone was a pain drug that was pulled off the market after a mere half a year. While doctors tell patients not to take pain medication with alcohol, some do, and this is why it was pulled. Palladone worked as an extended-release narcotic, but when taken with alcohol, it would dump everything in the body at once. This led to slowing breathing, coma, and sometimes death.
You may remember Quaaludes, or at least recall the scene from The Wolf of Wall Street when Jordon used them. The official reason for the recall was it caused mania, seizures, vomiting, convulsions, and sometimes death. That being said, the real reason it was banned was that people abused it to get a powerful high. This would often lead to death.
Hismanal was an antihistamine that was on the market for 11 years before it was pulled in 1999. Apparently, this drug would cause fatal heart rhythm disturbances when used at higher dosages. It could also cause this problem when combined with other medications.
Raplon, created by Organon International, was a powerful muscle relaxant that was mainly used as anesthesia. The FDA allowed it to be released to the market despite the fact it could cause airway spasms, blocking normal breathing. Clinical trials showed that the spasms occurred in 3.2% of patients. After being on the market for nine months, a total of five people died.
Baycol was only on the market for four years. It was prescribed to treat high cholesterol, but it turned out to be lethal. The drug caused rhabdomyolysis, which is the breakdown of muscle fibers. There was a total of 64 deaths and 385 hospitalizations before the drug was pulled. Some reports claim that the death toll was actually higher than 100. LipoBay used the same active ingredient and ended up with the same fate.
Permax was used as a treatment for Parkinson’s disease but was banned in 2007. Patients began to experience something called valve regurgitation. This is a condition where the values don’t close all the way, and blood flows backward over the valve. It can cause shortness of breath, heart palpitations, and fatigue. The drug is still sometimes used in the United States for veterinary use (called Prascend), but it’s banned for human consumption.
Irritable bowel syndrome is challenging to live with, but Lotronex showed that the treatment could be worse than the issue. It was on the market for nine months before it was removed due to 49 causes of ischemic colitis (inflammation and injury of the large intestine), 21 cases of severe constipation (10 requiring surgery), and 5 deaths due to mesenteric ischemia (inflammation and injury of the small intestine).
Vioxx was a pain reliever that was used as an NSAID. It was on the market for five years even though it’s now considered one of the most dangerous drugs ever prescribed. It carried the increased risk of heart attack and stroke and was linked to over 27,000 heart attacks or sudden cardiac arrests.
Raptiva was a psoriasis treatment that was on the market for six years. It was recalled in 2009 because it caused progressive multifocal leukoencephalopathy. Better known as PML, this is a rare and usually fatal disease that causes inflammation and damage to the white matter of the brain. Symptoms of PML included unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes.
Weight loss drugs are bad, okay? Redux is dexfenfluramine – which is one-half of the drug Fen-Phen. This drug was approved in the mid-1990s but was pulled in 1997 after the FDA became concerned about the cardiovascular side effects.
Posicor was designed to treat hypertension and was introduced in 1997. It only lasted a year before the FDA realized that it was dangerous. It turns out that Posicor had fatal interactions with at least 25 other drugs, including common antibiotics, antihistamines, and cancer drugs. Posicor didn’t offer any significant benefits over other anti-hypertensive medications, so there was no reason to keep this potentially fatal prescription on the market.
Meridia had a much longer run when compared to most other weight-loss drugs. Another appetite suppressant, Meridia was pulled in 2010 when the FDA found there was a high number of cardiovascular events. Eventually, Meridia was called another “Vioxx,” which is another dangerous prescription that caused over 27,000 heart attacks or sudden cardiac arrests.
Pondimin was another drug that was supposed to help you lose weight. It did this by suppressing your appetite, but it was more dangerous than it let on. Pondimin is fenfluramine, one part of the other dangerous medication Fen-Phen. Like Fen-Phen, it caused abnormal echocardiograms. There were 33 cases of rare valvular disease in women and 66 reports of heart valve disease.
Rezulin was pulled from the market in 2000 after being available for over three years. It was supposed to help treat diabetes, but patients began to experience liver issues. Some reports say that there were at least 63 deaths due to the drug, but one FDA epidemiologist estimated that Rezulin could be linked to over 430 liver failures.
Bextra was an NSAID pain reliever that released in 2001. It lasted for a few years before it was yanked. Why? Reports started to come in that it could cause serious cardiovascular events like stroke and death. It also had an increased risk of skin reactions and gastrointestinal bleeding. Considering it had no advantage over other NSAIDs on the market, the FDA decided it shouldn’t be on the market.
Propulsid was supposed to treat severe GERD, gastroesophageal reflux disease. Before the seven-year mark, Propulsid caused over 270 cases of cardiac arrhythmias, and over 70 people died. While it’s still available in some countries, the United States banned the drug for human consumption. It’s still used in animals.
Accutane was an extremely popular acne medication that was used for 27 years. However, the drug caused an increased risk of birth defects, miscarriages, and premature births. It also had higher chances of causing inflammatory bowel disease and suicidal tendencies. Over 7,000 lawsuits were filed against the company, and they paid out over $28 million.
Zelnorm appeared in 2002 but would be pulled by 2007. It was used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation. Since it was used in women over 55, patients already had an enhanced risk of stroke and heart attack. Well, Zelnorm increased that risk even further. Now, Zelnorm is only available in emergencies and requires prior authorization from the FDA.
Selacryn was a blood pressure medication that released in 1979. Before it was released, the lab which developed the drug sent a report to the distributor, SmithKline, stating that Selacryn damaged livers. SmithKline ignored the report and continued selling it. By 1982, it was pulled from the market. In 1984, SmithKline pled guilty to 14 counts of failing to file reports with the FDA and 20 counts of falsely labeling a drug.
Merital and Alival
Merital and Alival are two brand names for the drug nomifensine. They were used to treat depression. Initially, they were safer than any other tricyclic antidepressant on the market, although the FDA discovered that negative side effects included heart palpitations, tachycardia, and renal failure. In 1992, three years after approval, the FDA withdrew its approval due to an enhanced risk of anemia due to the breakdown of red blood cells.
PTZ and Metrazol
PTZ and Metrazol were brand names for the drug pentylenetetrazol. These two medications were used as convulsive therapy for schizophrenia and other psychiatric conditions. It popped up in 1934 and remained on the market for a ridiculously-long 48 years. Pentylenetetrazol was pulled from the market in 1984 because it would cause uncontrollable seizures, fractures bones, and spine fractures in as many as 42% of patients.
Seldane was one of the first antihistamines designed to treat allergy symptoms without making the patient drowsy. After a few years, it became clear that it had other problems. When combined with common antibiotics and anti-fungal drugs, it caused irregular heart rhythms. Before being pulled, there were 40 reports of serious heart rhythm abnormalities caused by Seldane.
Cylert was an ADHD/ADD treatment that was removed from the market in 2010. Abbott Laboratories originally stated that it made this move because of falling sales, but Cylert had issues with safety. The nonprofit group Public Citizen found that Cylert caused 13 cases of acute liver failure, which resulted in 11 transplants. Then, there were 193 “adverse drug reactions involving the liver in patients younger than 20 years old.”
Darvon and Darvocet
Darvon and Darvocet are the brand name medications for the drug propoxyphene. The medication was prescribed for 55 years until 2010 when it was removed due to toxicity to the heart. The recall plea came from Public Citizen, a nonprofit group, who claimed that the FDA was negligent and there were “at least 1,000 to 2,000 more people in the U.S.” who died from taking this medication.
Trasylol was used to reduce blood loss during surgery. Questions about safety have been brought up regularly throughout the drug’s history. Anaphylaxis occurred in 1 out of every 200 patients in first-time use. Furthermore, it had an increased risk of serious kidney damage, congestive heart failure, strokes, and could even cause death.
Micturin (created by Forest Labs) helped those that suffered from bladder incontinence. It was only on the market for two years from 1989 to 1991. The FDA removed it because it caused irregular heart rhythms and had the potential for cardiotoxicity. Thankfully, Micturin didn’t kill anyone while it was on the market.
DES, or diethylstilbestrol, was synthetic estrogen that was used to prevent a miscarriage, premature labor, and several other pregnancy complications. After being used for 31 years, it became clear that the drug could cause cancer of the cervix and vagina. It also caused birth defects and other developmental abnormalities. Overall, the drug did a lot more harm than good, and it was taken off the market in 1971.
Mylotarg was used to treat acute myeloid leukemia from 2000 to 2010. However, studies began to show that the medication increased patient death and had no additional benefit over types of cancer therapies. Some countries didn’t agree with the FDA’s decision, but that doesn’t change the fact it hasn’t been used in the United States since.
Zelmid (designed by AstraZeneca) was one of the first selective serotonin reuptake inhibitors (SSRI) antidepressants. The medication had a favorable safety profile, but after a year and a half, all drugs using the active ingredient zimelidine were banned. It became evident that the ingredient could cause Guillain-Barre syndrome, which is when there’s rapid-onset muscle weakness because the body’s immune system is attacking the nervous system.
Duract was a pain-killer that was used from 1997 to 1998. During this short year, Duract was the cause of four deaths. On top of that, 8 patients required liver transplants with 12 patients getting severe liver damage because of the medication. It was labeled to be used for 10 days, but patients often took it longer.
Ergamisol, or levamisole, was used for 11 years as a way to help several medical issues including worm infestation, colon and breast cancers, and rheumatoid arthritis. It was recalled because it caused low white blood cell counts. Along with this, it also increased the risk of clots in blood vessels and purple discoloration of the skin that sometimes required surgery.
Omniflox was on the market for less than five months in 1992 and was used to treat pneumonia, bronchitis, and other respiratory tract infections. The reason it was jerked from the market was that it caused three deaths. Omniflox caused severely low blood sugar, anemia, and kidney dysfunction.
Immunoprin is the brand name for the medication thalidomide. This medication was used around 50 years ago and led to the FDA cracking down on approving drugs that weren’t safe. After an extensive study, the FDA discovered that thalidomide caused birth defects, excessive blood clots, and damaged nerves. Some patients even ended up with irreversible peripheral neuropathy.
PPA (brand name Proin) was used in over-the-counter nasal decongestants and weight control products, but in 2000, it all came crashing down. Any medication using this ingredient was pulled from the market because of its increased risk of cardiac events and strokes. The FDA never approved the use of this drug, and the administration later estimated that 200 to 500 strokes per year could have been prevented if PPA wasn’t used.
Desoxyn is still on the market, which is alarming. Desoxyn’s active ingredient is methamphetamine hydrochloride. This legal meth is used to treat obesity and children who have behavioral syndromes. Desoxyn already has warnings because it’s been extensively abused, but the FDA hasn’t pulled it from the market.
Chantix is a smoking cession drug, but that isn’t all it is. Several organizations have pled with the FDA to remove it from the market. The FDA forced Pfizer, the creator, to put a black box on the prescription, which is the strictest warning possible. The reason? It increases suicidal behavior and depression in those using the drug to quit smoking.
Ergoapiol was a combination of ergot and apiol. It was supposed to treat menstrual irregularities, but it did much more than that. Ergot is a type of fungus that grows on rye grain and is incredibly toxic because it’s able to reduce blood flow so much that gangrene can take hold. Apiol caused abortions and could even damage the liver and kidneys.
Nembutal was a barbiturate sold in the 20s. What made this drug particularly dangerous was the fact that it was marketed for children who experienced anxiety during medical procedures. Patients that took Nembutal could easily become addicted, and overdoses weren’t uncommon.
Norodin is one of the scariest medications ever. It was the brand name methamphetamine and was used to treat depression. The company who made the drug advertised that it had “relatively few side effects.” Today, we know of the multitude of issues that could come with using this medication including tooth grinding, anorexia, irregular heartbeat, heart attacks, and stroke.