Posted on May 13, 2021, 4 p.m.
According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.” The agency also takes into account the number of people using the drug that is being considered for a recall as to not harm those people.
You may not be aware that many drugs have gained FDA approval but later on have been recalled from the markets. Some mistakenly argue that approval means that a drug is safe, but just because a drug has gained approval/clearance does not necessarily mean that it is safe, and it does not guarantee it to be free of unwanted or serious side effects. This is not to say that all medications are bad, more so to be aware of any side effects that you may be experiencing from prescriptions, and follow up on it with your physician.
Before moving on, it is worth pointing out that these drugs had full approval which is different than that of authorization for emergency use. An EUA is a mechanism used to facilitate the availability and use of medical countermeasures during a public health emergency. Under an EUA the FDA may allow the use of unapproved medical products, including experimental drugs, in an emergency when certain minimum statutory criteria have been met, including that there are no adequate, approved, and available alternatives. When the emergency situation is clear, any products being used under an EUA can no longer be used and must submit for full approval and regulatory procedures for continued use.
Below is a sample of some of the drugs that were recalled from the American market since the 1970s, some of which were in use for decades before removal:
- Accutane (Isotretinoin) used for acne, manufactured by Hoffman-La Roche, was on the market for 27 years until June 2009. Recalled due to increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies. Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.
- Baycol (Cerivastatin) used for cholesterol reduction, manufactured by Bayer A.G, it was on the market for 3 years until August 2001. Recalled due to rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid).
- Bextra ( Valdecoxib) used as an NSAID for pain relief, manufactured by G.D. Searle & CO., on the market for 3 years until April 2005. Recalled due to serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleeding. The FDA determined that Bextra showed no advantage over other NSAID pain relievers on the market.
- Cylert (Pemoline) used as a central nervous system stimulant to treat ADD/ADHD, manufactured by Abbott Laboratories, this was on the market for 30 years until October 2020. Recalled for liver toxicity. The FDA added a box warning to Cylert in 1999, alerting doctors and patients to the potential of liver damage.
- Darvon & Darvocet (Propoxyphene) used as an opioid pain reliever, manufactured by Xanodyne, was on the market for 55 years until November 2010. Recalled due to serious toxicity to the heart; between 1981 and 1999 there were over 2,110 deaths reported. The UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen.
- DBI (Phenformin) used as an antidiabetic, manufactured by Ciba-Geigy, it was on the market for 19 years until November 1978. It was recalled due to lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes.
- DES (Diethylstilbestrol) used as a synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications, manufactured by Grant Chemical Co., was on the market for 31 years until 1971. This was recalled due to clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third-generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning. Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.
- Duract (Bromfenac) used a pain killer, manufactured by Wyeth-Ayerst Laboratories, this was on the market from July 1997 to June 1998. This was recalled due to 4 deaths; 8 patients requiring liver transplants; 12 patients with severe liver damage. Duract was labeled for maximum use of 10 days but patients often received/took more than 10 days worth of pills; all cases of death and liver damage involved patients taking pills for longer than 10 days.
- Ergamisol (Levamisole) used for worm infestation; colon and breast cancers; and rheumatoid arthritis, manufactured by Janssen Pharmaceutica, and was on the market for 11 years until May 2000. It was recalled due to neutropenia (a type of low white blood cell count), agranulocytosis (a type of low white blood cell count), and thrombotic vasculopathy (blood clots in blood vessels) which results in retiform purpura (a purple discoloration of the skin that can sometimes require reconstructive surgery). Levamisole is still used to treat animals with worm infestations in the US. It is also being found in street cocaine as an adulterant to increase euphoric qualities.
- Hismanal (Astemizole) used as an antihistamine, manufactured by Janssen Pharmaceutica, it was on the market for 11 years until August 1999. This was recalled due to slowed potassium channels in the heart that could cause torsade de Pointes (TdP; a heart condition marked by a rotation of the heart’s electrical axis) or long QT syndrome (LQTS; prolonged QT intervals).
- Lotronex (Alosetron) used for irritable bowel syndrome in women, manufactured by Prometheus Laboratories Inc., and was on the market from February 2000 to November 2000. It was recalled due to 49 cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine). Lotronex was reintroduced to the US market in 2002 with restricted indication.
- Meridia ( Sibutramine) used as an appetite suppressant, manufactured by Knoll Pharmaceuticals, and was on the market for 13 years until 2010. It was recalled due to increased cardiovascular and stroke risk. FDA reviewer Dr. David Graham listed Meridia with Crestor, Accutane, Bextra, and Serevent as drugs whose sales should be limited or stopped because of their danger to consumers in Sep. 30, 2004 testimony before a Senate committee, calling the drugs “another Vioxx.”
- Merital & Alical (Nomifensine) used as an antidepressant, manufactured by Hoechst AG (now Sanofi-Aventis), and on the market for 3 years until 1985. This was recalled due to haemolytic anemia; and some deaths due to immunohemolytic anemia.
- Micturin (Terodiline) used for bladder incontinence, manufactured by Forest Labs, and on the market for 2 years until September 1991. Was recalled due to QT prolongation and potential for cardiotoxicity.
- Mylotarg (Gemtuzumab Ozogamicin) used for Acute myeloid leukemia, manufactured by Wyeth, and was on the market for 10 years until 2010. It was recalled due to an increased risk of death and veno-occlusive disease (obstruction of veins).
- Omniflox (Temafloxacin) used as an antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments, manufactured by Abbot Laboratories, and was on the market from January 1992 to June 1992. This was recalled due to 3 deaths; severely low blood sugar; hemolytic anemia and other blood cell abnormalities; kidney dysfunction (half of the cases required renal dialysis); allergic reactions including some causing life-threatening respiratory distress.
- Palladone (Hydromorphone hydrochloride, extended-release) a narcotic painkiller manufactured by Purdue Pharma that was on the market from January 2005 to July 2005. This was recalled due to high levels of palladone could slow or stop breathing, or cause coma or death; combining the drug with alcohol use could lead to rapid release of hydromorphone, in turn leading to potentially fatally high levels of drugs in the system.
- Permax (Pergolide) used for Parkinson’s Disease, manufactured by Valeant, and was on the market for 19 years until 2007. This was recalled due to valve regurgitation (a condition that causes the valves to not close tightly, which allows blood to flow backward over the valve) in the mitral, tricuspid, and aortic heart valves, which can result in shortness of breath, fatigue, and heart palpitations. Permax is still available in the U.S. for veterinary use, specifically for pituitary pars intermedia hyperplasia or equine Cushing’s Syndrome (ECS) in horses.
- Pondimin (Fenfluramine) used as an appetite suppressant, manufactured by Wyeth-Ayerst, and was on the market for 24 years until 1997. This was recalled due to 30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve disease. Pondimin is better known as “Fen-Phen” when prescribed with Phentermine.
- Posicor (Mibefradil) a calcium channel blocker used to treat hypertension, manufactured by Roche Laboratories, and was on the market for 1 year until 1998. This was recalled due to fatal interactions with at least 25 other drugs (ex: common antibiotics, antihistamines, and cancer drugs) including astemizole, cisapride, terfenadine, lovastatin, and simvastatin. Posicor was found by the FDA to offer no significant benefit over other anti-hypertensive or antianginal drugs, which made the risks of drug interactions “unreasonable.” Patients immediately switching from Posicor to another calcium channel blocker were at increased risk of going into shock within 12 hours of the drug switch.
- Propulsid (Cisapride) used for severe nighttime heartburn associated with gastroesophageal reflux disease, manufactured by Janssen Pharmaceutica, and was on the market for 7 years until 2000. This was recalled due to more than 270 cases of serious cardiac arrhythmias (including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation) reported between July 1993 and May 1999, with 70 being deaths. Propulsid is also banned in India (2011) and available for limited use in Europe. It is still available for use in animals in the US and Canada.
- PTZ & Metrazol (Pentylenetetrazol) used in convulsive therapy for schizophrenia and other psychiatric conditions, the manufacturer is not known, and it was on the market for 48 years until 1982. This was recalled due to uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients.
- Quaalude [Marketed as: Optimal, Sopor, Parest, Somnafac, and Bi-Phetamine T] (Methaqualone) used as a sedative and hypnotic, manufactured by William H. Rorer Ince. & Lemmon Company, on the market for 23 years until 1985. This was recalled due to mania; seizures; vomiting; convulsions; and death. Methaqualone was originally tested in India as a malaria treatment (it was ineffective). The drug is now a schedule 1 drug in the United States (like heroin, marijuana, and LSD).
- Raplon (Rapacuronium) used as a non-polarizing neuromuscular blocker in anesthesia, manufactured by Organon Inc, on the market for 2 years until 2001. This was recalled due to bronchospasms and unexplained deaths.
- Raptiva (Efalizumab) used in psoriasis, manufactured by Genentech, on the market for 6 years until 2009. This was recalled due to progressive multifocal leukoencephalopathy (PML; a rare and usually fatal disease that causes inflammation or progressive damage of the white matter in multiple locations of the brain).
- Raxar (Grepafloxcin) was used as an antibiotic for bacterial infections, manufactured by Glaxo Wellcome, on the market for 2 years until 1999. This was recalled due to cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes).
- Redux (Dexfenfluramine) used as an appetite suppressant, manufactured by Wyeth-Ayerst, on the market from 1996 to Sept 1997. This was recalled due to 30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve disease. Redux is better known as “Fen-Phen” when prescribed with Phentermine.
- Rezulin (Troglitazone) an antidiabetic and anti-inflammatory manufactured by Parke-Davis/Warner-Lambert (now Pfizer), on the market for 3 years until 2000. This was recalled due to at least 90 liver failures; at least 63 deaths. About 35.000 personal injury claims were filed against the manufacturer (Pfizer).
- Selacryn (Tienilic acid) used for blood pressure, manufactured by SmithKline, was on the market for 3 years. This was recalled due to hepatitis; 36 deaths; at least 500 cases of severe liver and kidney damage. Anphar Labs (which developed the drug in France and sold rights to sell in the US to SmithKline) sent a report to SmithKline in Apr. 1979 (translated in May 1979 to English from French) stating Selacryn damaged livers. On Dec. 13, 1984, SmithKline Beckman plead guilty to “14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage”.
- Seldane (Terfenadine), an antihistamine manufactured by Hoechst Marion Roussel (now Sanofi-Aventis), was on the market for 13 years until 1998. This was recalled due to life-threatening heart problems when taken in combination with other drugs (specifically erythromycin (an antibiotic) and ketoconazole (an antifungal). Seldane was not considered an imminent threat. The FDA pulled Seldane from the market because Allegra and Allegra D were produced by the same company and were deemed safer by the FDA.
- Trasylol (Aprotinin) an antifibrinolytic to reduce blood loss during surgery manufactured by Bayer, and was on the market for 48 years until the eventual complete removal in 2008. This was recalled due to an increased chance of death, serious kidney damage, congestive heart failure, and strokes. On Feb. 8, 2006, the FDA issued a public health advisory to surgeons who perform heart bypasses, alerting them of possible fatal side effects.
- Vioxx (Rofecoxib) and NSAID for pain relief manufactured by Merck, on the market for 5 years until September 2004. This was recalled due to increased risk of heart attack and stroke; linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999, and 2003. Ads for Vioxx features Olympic gold medalists Dorothy Hamill and Bruce Jenner. Vioxx was prescribed to more than 20 million people.
- Xigris (Drotrecogin alfa (activated)) used in severe sepsis and septic shock, manufactured by Eli Lilly & Company, was on the market for 10 years until 2011. This was recalled due to there being no survival benefit.
- Zelmid (Zimelidine) used as an anti-depressant, manufactured by Astra AB ( now AstraZeneca), this drug was approved by the FDA but withdrawn before release to market due to causing Guillain–Barré syndrome; and a higher risk of suicide.
- Zelnorm (Tegaserod maleate) used in IBS with constipation and chronic idiopathic constipation in women younger than 55, manufactured by Novartis, on the market for 4 years until 2007. This was recalled due to a higher chance of heart attack, stroke, and unstable angina (heart/chest pain). The FDA permitted restricted use of Zelnorm on an emergency basis (with prior case-by-case authorization from the FDA) on July 27, 2007.
As with anything you read on the internet, this article should not be construed as medical advice; please talk to your doctor or primary care provider before making any changes to your wellness routine.
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