FDA-Approved Prescription Drugs Later Pulled from the Market by the FDA

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 FDA also takes into account the number of people taking a drug being considered for removal so as to not harm those patients.

The drugs below have been removed from the market by the FDA for various reasons, but the list should not be considered exhaustive. For more information, please consult the FDA’s “Recalls, Market Withdrawals, & Safety Alerts” page, or their Twitter account.

Baycol
(Cerivastatin)

Manufacturer: Bayer A.G.

Medical Use(s): cholesterol reduction

Cause for Recall: rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure

The drug caused 52 deaths (31 in the US) worldwide and 385 nonfatal cases with most requiring hospitalization. 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid).

Belviq, Belviq XR
(Lorcaserin)

Manufacturer: Eisai Inc.

Medical Use(s): weight loss

Cause for Recall: potential cancer risk

The FDA stated, “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety.”DMA) amounts above appropriate levels

Bextra
(Valdecoxib)

Manufacturer: G.D. Searle & Co.

Medical Use(s): NSAID (pain relief)

Cause for Recall: 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)

Manufacturer: Abbott Laboratories

Medical Use(s): central nervous system stimulant to treat ADHD/ADD

Cause for Recall: liver toxicity

The FDA added a box warning to Cylert in 1999, alerting doctors and patients to the potential of liver damage, which prompted the manufacturer to stop production of the drug.

Darvon & Darvocet
(Propoxyphene)

Manufacturer: Xanodyne

Medical Use(s): opioid pain reliever

Cause for Recall: 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)

Manufacturer: Ciba-Geigy

Medical Use(s): antidiabetic

Cause for Recall: lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes

DES
(Diethylstibestrol)

Manufacturer: Grant Chemical Co.

Medical Use(s): synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications

Cause for Recall: 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)

Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.

Duract
(Bromfenac)

Manufacturer: Wyeth-Ayerst Laboratories

Medical Use(s): pain killer

Cause for Recall: 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)

Manufacturer: Janssen Pharmaceutica

Medical Use(s): worm infestation; colon and breast cancers; rheumatoid arthritis

Cause for Recall: 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 has also been found in street cocaine as an adulterant to increase euphoric qualities.

Hismanal
(Astemizole)

Manufacturer: Janssen Pharmaceutica

Medical Use(s): antihistamine

Cause for Recall: 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)

Manufacturer: Prometheus Laboratories, Inc.

Medical Use(s): irritable bowel syndrome (IBS) in women

Cause for Recall: 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)

Manufacturer: Knoll Pharmaceuticals

Medical Use(s): appetite suppressant

Cause for Recall: 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 & Alival
(Nomifensine)

Manufacturer: Hoechst AG

Medical Use(s): antidepressant

Cause for Recall: haemolytic anemia; some deaths due to immunohemolytic anemia

Micturin
(Terodiline)

Manufacturer: Forest Labs

Medical Use(s): bladder incontinence

Cause for Recall: QT prolongation and potential for cardiotoxicity

Mylotarg
(Gemtuzumab Ozogamicin)

Manufacturer: Wyeth-Ayerst Laboratories

Medical Use(s): acute myeloid leukemia (AML, a bone marrow cancer)

Cause for Recall: increased risk of death and veno-occlusive disease (obstruction of veins)

Omniflox
(Temafloxacin)

Manufacturer: Abbot Laboratories

Medical Use(s): antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments

Cause for Recall: 3 deaths; severe low blood sugar; hemolytic anemia and other blood cell abnormalities; kidney disfunction (half of the cases required renal dialysis); allergic reactions including some causing life-threatening respiratory distress

Palladone
(Hydromorphone hydrochloride, extended-release)

Manufacturer: Purdue Pharma

Medical Use(s): narcotic painkiller

Cause for Recall: 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)

Manufacturer: Valeant

Medical Use(s): Parkinson’s disease

Cause for Recall: 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)

Manufacturer: Wyeth-Ayerst

Medical Use(s): appetite suppressant

Cause for Recall: 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 was better known as “Fen-Phen” when prescribed with Phentermine.

Posicor
(Mibefradil)

Manufacturer: Roche Laboratories

Medical Use(s): calcium channel blocker (used to treat hypertension)

Cause for Recall: 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)

Manufacturer: Janssen Pharmaceutica

Medical Use(s): severe nighttime heartburn associated with gastroesophageal reflux disease (GERD)

Cause for Recall: more than 270 cases of serious cardiac arrythmias (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)

Manufacturer: unknown

Medical Use(s): convulsive therapy for schizophrenia and other psychiatric conditions

Cause for Recall: uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients

Quaalude
(Methaqualone)
[Marketed as: Optimal, Sopor, Parest, Somnafac, and Bi-Phetamine T]

Manufacturer: William H. Rorer Inc. & Lemmon Company

Medical Use(s): sedative and hypnotic

Cause for Recall: mania; seizures; vomiting; convulsions; 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)

Manufacturer: Organon Inc.

Medical Use(s): non-polarizing neuromuscular blocker (used in anesthesia)

Cause for Recall: bronchospasms and unexplained deaths

Raptiva
(Efalizumab)

Manufacturer: Genentech

Medical Use(s): psoriasis

Cause for Recall: 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
(Grepafloxacin)

Manufacturer: Glaxo Wellcome

Medical Use(s): antibiotic for bacterial infections

Cause for Recall: cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes)

Redux
(Dexfenfluramine)

Manufacturer: Wyeth-Ayerst

Medical Use(s): appetite suppressant

Cause for Recall: 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)

Manufacturer: Parke-Davis/Warner Lambert

Medical Use(s): antidiabetic and anti-inflammatory

Cause for Recall: at least 90 liver failures; at least 63 deaths

About 35.000 personal injury claims were filed against the manufacturer.

Selacryn
(Tienilic acid)

Manufacturer: SmithKline

Medical Use(s): blood pressure

Cause for Recall: 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 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)

Manufacturer: Hoechst Marion Roussel

Medical Use(s): antihistamine

Cause for Recall: life-threatening heart problems when taken in combination with other drugs (specifically erthromycin (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)

Manufacturer: Bayer

Medical Use(s): antifibrinolytic to reduce blood loss during surgery

Cause for Recall: increased chance of death, serious kidney damage, congestive heart failure, and strokes

On Feb. 8, 2006, the FDA issued a public heath advisory to surgeons who perform heart bypasses, alerting them of possible fatal side effects.

Vioxx
(Rofecoxib)

Manufacturer: Merck

Medical Use(s): NSAID (pain relief)

Cause for Recall: 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 featured Olympic gold medalists including Dorothy Hamill. Vioxx was prescribed to more than 20 million people.

Xigris
(Drotrecogin alfa activated)

Manufacturer: Eli Lilly & Company

Medical Use(s): severe sepsis and septic shock

Cause for Recall: no survival benefit

Zantac
(Ranitidine)

Manufacturer: Sanofi

Medical Use(s): heartburn

Cause for Recall: potential N-Nitrosodimethylamine (NDMA) amounts above appropriate levels

According to the FDA, “NDMA is classified as a probable human carcinogen (a substance that could cause cancer).”

Zelmid
(Zimelidine)

Manufacturer: Astra AB

Medical Use(s): anti-depressant

Cause for Recall: Guillain–Barré syndrome; higher risk of suicide

Zelnorm
(Tegaserod maleate)

Manufacturer: Novartis

Medical Use(s): irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55

Cause for Recall: 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.

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