35 FDA-Approved Prescription Drugs Later Pulled from the Market



Below are the 35 drugs we could find that have been recalled from the US market since the 1970s, some that had been in use since the 1930s. A sample of advertisements for only some of the drugs are included because there is a scarcity of ads for withdrawn drugs online due to manufacturers removing ads for withdrawn drugs as part of the agreement to no longer market the drugs.

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.



1. Accutane (Isotretinoin) on the market for
27
YEARS
Use: Acne
Manufacturer: Hoffman-La Roche
1982 to June 2009
Cause for recall:
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.


2. Baycol (Cerivastatin) on the market for
3
YEARS
Use: Cholesterol reduction
Manufacturer: Bayer A.G.
1998 to Aug. 2001
Cause for recall:
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)


3. Bextra (Valdecoxib) on the market for
3.3
YEARS
Use: NSAID (pain relief)
Manufacturer: G.D. Searle & Co.
Nov. 20, 2001 to Apr. 7, 2005
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.
bextra prescription drug ad
Bernadette Tansey, "Hard Sell: How Marketing Drives the Pharmaceutical Industry/The Side Effects of Drug Promotion/Aggressive Ads for Painkillers Left More Patients Exposed to Risk," www.sfgate.com, Feb. 27, 2005


4. Cylert (Pemoline) on the market for
30
YEARS
Use: Central nervous system stimulant to treat ADHD/ADD
Manufacturer: Abbott Laboratories
1975 to Oct. 2010
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.
cylert prescription drug ad
Abbott Laboratories, "Cylert," American Journal of Diseases of Children, www.bonkersinstitute.org, 1976


5. Darvon & Darvocet (Propoxyphene) on the market for
55
YEARS
Use: Opioid pain reliever
Manufacturer: Xanodyne
1955 to
Nov. 19, 2010
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.
darvon prescription drug ad
Christian Sinclair, "Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?," www.pallimed.org, Nov. 30, 2010


6. DBI (Phenformin) on the market for
19
YEARS
Use: antidiabetic
Manufacturer: Ciba-Geigy
1959 to Nov. 1978
Cause for recall:
lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes


7. DES (Diethylstibestrol) on the market for
31
YEARS
Use: synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications
Manufacturer: Grant Chemical Co.
1940 to 1971
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) 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.
DES prescription drug ad
Barbara Hammes and Cynthia Laitman, "Pharmaceutical Company Advertisement for DES by the Grant Chemical Company, Brooklyn, NY, Printed in the American Journal of Obstetrics & Gynecology in 1957," Journal of Midwifery and Women's Health, www.medscape.com, 2003


8. Duract (Bromfenac) on the market for
1
YEAR
Use: Pain killer
Manufacturer: Wyeth-Ayerst Laboratories
July 1997 to
June 26, 1998
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.


9. Ergamisol (Levamisole) on the market for
11
YEARS
Use: Worm infestation; colon and breast cancers; rheumatoid arthritis
Manufacturer: Janssen Pharmaceutica
May 8, 1989 to 2000
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 is also being found in street cocaine as an adulterant to increase euphoric qualities.


10. Hismanal (Astemizole) on the market for
11
YEARS
Use: Antipsychotic
Manufacturer: Janssen Pharmaceutica
1988 to
Aug. 13, 1999
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)


11. Lotronex (Alosetron) on the market for
0.8
YEAR
Use: Irritable bowel syndrome (IBS) in women
Manufacturer: Prometheus Laboratories, Inc.
Feb. 9, 2000 to Nov. 28, 2000
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.
lotronex prescription drug ad
Irritable Bowel Syndrome Self Help and Support Group, "Lotronex," www.ibsgroups.org (accessed Jan. 6, 2014)


12. Meridia (Sibutramine) on the market for
13
YEARS
Use: Appetite Suppressant
Manufacturer: Knoll Pharmaceuticals
Nov. 1997 to
Oct. 2010
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."


13. Merital & Alival (Nomifensine) on the market for
3
YEARS
Use: Antidepressant
Manufacturer: Hoechst AG (now Sanofi-Aventis)
1982 to 1985
Cause for recall:
haemolytic anemia; some deaths due to immunohemolytic anemia


14. Micturin (Terodiline) on the market for
2
YEARS
Use: Bladder incontinence
Manufacturer: Forest Labs
Aug. 1989 to
Sep. 13, 1991
Cause for recall:
QT prolongation and potential for cardiotoxicity


15. Mylotarg (Gemtuzumab Ozogamicin) on the market for
10
YEARS
Use: Acute myeloid leukemia (AML, a bone marrow cancer)
Manufacturer: Wyeth
May 2000 to
June 21, 2010
Cause for recall:
increased risk of death and veno-occlusive disease (obstruction of veins)


16. Omniflox (Temafloxacin) on the market for
0.3
YEAR
Use: Antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments.
Manufacturer: Abbot Laboratories
Jan. 31, 1992 to June 5, 1992
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


17. Palladone (Hydromorphone hydrochloride, extended-release) on the market for
0.5
YEAR
Use: Narcotic painkiller
Manufacturer: Purdue Pharma
Jan. 2005 to
July 13, 2005
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


18. Permax (Pergolide) on the market for
19
YEARS
Use: Parkinson's disease
Manufacturer: Valeant
1988 to Mar. 29, 2007
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.


19. Pondimin (Fenfluramine) on the market for
24
YEARS
Use: Appetite suppressant
Manufacturer: Wyeth-Ayerst
1973 to
Sep. 15, 1997
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 is better known as "Fen-Phen" when prescribed with Phentermine.


20. Posicor (Mibefradil) on the market for
1
YEAR
Use: Calcium channel blocker (used to treat hypertension)
Manufacturer: Roche Laboratories
June 1997 to
June 1998
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.


21. Propulsid (Cisapride) on the market for
7
YEARS
Use: Severe nighttime heartburn associated with gastroesophageal reflux disease (GERD)
Manufacturer: Janssen Pharmaceutica
1993 to July 14, 2000
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.


22. PTZ & Metrazol (Pentylenetetrazol) on the market for
48
YEARS
Use: Convulsive therapy for schizophrenia and other psychiatric conditions
Manufacturer: not known
1934 to 1982
Cause for recall:
uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients


23. Quaalude [Marketed as: Optimal, Sopor, Parest, Somnafac, and Bi-Phetamine T] (Methaqualone) on the market for
23
YEARS
Use: Sedative and hypnotic
Manufacturer: William H. Rorer Inc. & Lemmon Company
1962 to 1985
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).
quaalude prescription drug ad
Res Obscura, "From Quacks to Quaaludes: Three Centuries of Drug Advertising," www.resobscura.blogspot.nl, June 11, 2012


24. Raplon (Rapacuronium) on the market for
2
YEARS
Use: Non-polarizing neuromuscular blocker (used in anesthesia
Manufacturer: Organon Inc.
1999 to
Mar. 27, 2001
Cause for recall:
bronchospasms and unexplained deaths


25. Raptiva (Efalizumab) on the market for
6
YEARS
Use: Psoriasis
Manufacturer: Genentech
2003 to
Apr. 8, 2009
(completely withdrawn by
June 8, 2009)
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)


26. Raxar (Grepafloxacin) on the market for
2
YEARS
Use: Antibiotic for bacterial infections
Manufacturer: Glaxo Wellcome
1997 to
Nov. 1, 1999
Cause for recall:
cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes)


27. Redux (Dexfenfluramine) on the market for
1
YEAR
Use: Appetite suppressant
Manufacturer: Wyeth-Ayerst
1996 to Sep. 15, 1997
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.


28. Rezulin (Troglitazone) on the market for
3.25
YEARS
Use: Antidiabetic and anti-inflammatory
Manufacturer: Parke-Davis/Warner Lambert (now Pfizer)
Jan. 29, 1997 to Mar. 21, 2000
Cause for recall:
at least 90 liver failures; at least 63 deaths

About 35.000 personal injury claims were filed against the manufacturer (Pfizer).


29. Selacryn (Tienilic acid) on the market for
3
YEARS
Use: blood pressure
Manufacturer: SmithKline
May 2, 1979 to 1982
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"


30. Seldane (Terfenadine) on the market for
13
YEARS
Use: Antihistamine
Manufacturer: Hoechst Marion Roussel (now Sanofi-Aventis)
1985 to
Feb. 1, 1998
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.


31. Trasylol (Aprotinin) on the market for
15 (48)
YEARS
Use: antifibrinolytic to reduce blood loss during surgery
Manufacturer: Bayer
1993 (but used since the 1960s) to Nov. 5, 2007 (marketing suspension request to phase it out of the market);
May 14, 2008 (manufacturer announced complete removal from market)
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.


32. Vioxx (Rofecoxib) on the market for
5.3
YEARS
Use: NSAID (pain relief)
Manufacturer: Merck
May 20, 1999 to Sep. 30, 2004
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 features Olympic gold medalists Dorothy Hamill and Bruce Jenner. Vioxx was prescribed to more than 20 million people.
vioxx prescription drug ad
Today's Seniors Network, "This Is Patient Education?," www.todaysseniorsnetwork.com (accessed Jan. 7, 2014)


33. Xigris (Drotrecogin alfa (activated)) on the market for
10
YEARS
Use: Severe sepsis and septic shock
Manufacturer: Eli Lilly & Company
Nov. 2001 to
Oct. 25, 2011
Cause for recall:
no survival benefit


34. Zelmid (Zimelidine) on the market for
0
YEARS
Use: Anti-depressant
Manufacturer: Astra AB (now AstraZeneca)
1982 to 1982 (withdrawn by the FDA before being released in the US market)
Cause for recall:
Guillain–Barré syndrome; higher risk of suicide


35. Zelnorm (Tegaserod maleate) on the market for
4.6
YEARS
Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55
Manufacturer: Novartis
July 24, 2002 to Mar. 30, 2007
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.
zelnorm prescription drug ad
Adforum.com, "Zelnorm - 'N/A' - Deutsch NY," www.adforum.com (accessed Feb. 7, 2014)




Sources:

Abbott Laboratories, "Cylert," American Journal of Diseases of Children, www.bonkersinstitute.org, 1976

Adforum.com, "Zelnorm - 'N/A' - Deutsch NY," www.adforum.com (accessed Feb. 7, 2014)

AP, "Drug Maker Pleads Guilty over Lethal Side Effects," www.nytimes.com, Dec. 14, 1984

AstraZeneca, "AstraZeneca Decides to Withdraw Exanta TM," www.astrazeneca.com, Feb. 14, 2006

Michelle R. Carter and Sorour Amirhaeri, "p-ANCA-Associated Vasculitis Caused by Levamisole-Adulterated Cocaine: A Case Report," Case Reports in Emergency Medicine, www.hindawi.com, 2013

Marlene Cimons, "Seldane Pulled for a Safer Allergy Drug," www.latimes.com, Dec. 30, 1997

Dan Collins, "Insider: FDA Won't Protect Public," www.cbsnews.com, Dec. 7, 2004

Richard DeGrandpre, The Cult of Pharmacology: How America Became the World's Most Troubled Drug Culture, 2006

"Drugs: The Dangers of Analgesics," www.time.com, Feb. 24, 1967

Drugwatch, "What Is Accutane? It's Uses and Interactions," www.drugwatch.com/accutane, Dec. 10, 2013

Fairfield State Hospital, "Metrazol Therapy," www.fairfieldstatehospital.com, Jan. 15, 2013

FDA, "FDA Alerts Consumers of Undeclared Drug Ingredients in Over-the-Counter Diabetes Product," www.fda.gov, July 23, 2013

FDA, "FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen)," www.fda.gov, Sep. 15, 1997

FDA, "FDA Announces Voluntary Withdrawal of Pergolide Products: Agency Working with Product Manufacturers," www.fda.gov, Mar. 29, 2007

FDA, "FDA Approves First Treatment for Women with Constipation-Predominant Irritable Bowel Syndrome," www.web.archive.org, July 24, 2002

FDA, "FDA Drug Safety Communication: Voluntary Market Withdrawal of Xigris [drotrecogin alfa (activated)] Due to Failure to Show a Survival Benefit," www.fda.gov, Oct. 25, 2011

FDA, "FDA Issues Public Health Advisory for Trasylol," www.fda.gov, Feb. 8, 2006

FDA, "FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market," www.fda.gov, June 21, 2010

FDA, "FDA Requests Marketing Suspension of Trasylol," www.fda.gov, Nov. 5, 2007

FDA, "How Does FDA Decide When a Drug Is not Safe enough to Stay on the Market," www.fda.gov, Jan. 7, 2010

FDA, "Information for Healthcare Professionals: Pemoline Tablets and Chewable Tablets (marketed as Cylert)," www.fda.gov, Oct. 2005

FDA, "Information for Healthcare Professionals: Valdecoxib (marketed as Bextra)," www.fda.gov, Apr. 7, 2005

FDA, "Propulsid (cisapride) Dear Healthcare Professional Letter Jan 2000," www.fda.gov, Jan 24, 2000

FDA, "Propoxyphene: Withdrawal - Risk of Cardiac Toxicity," www.fda.gov, Nov. 19, 2010

FDA, "Public Health Advisory: Suspended Marketing of Palladone (hydromophone hydrocloride, extended-release capsules)," www.fda.gov, July 13, 2005

FDA, "Questions and Answers about Withdrawal of Duract," www.fda.gov, Aug. 23, 2013

FDA, "Questions and Answers about Withdrawal of Fenfluramine (Pondimine) and Dexfenfluramine (Redux)," www.fda.gov, July, 7, 2005

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