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 A sample of advertisements for only some of the drugs are included because there is a scarcity of ads for withdrawn drugs online due to manufacturers removing ads for withdrawn drugs as part of the agreement to no longer market the drugs.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. 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. 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. 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. 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: Antihistamine

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. 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 b etween 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). 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. 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