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 not to 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, and Safety Alerts” page or its X (formerly Twitter) account. [52][55][56][57][59][69][86][88][89][97][100][104][105][106]
Baycol (Cerivastatin)
Date of Approval: 1998
Date of Removal: August 2001
Manufacturer: Bayer A.G.
Medical Use: 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 U.S.) worldwide and 385 nonfatal cases, with most requiring hospitalization. Of those deaths, 12 were related to taking this drug in combination with gemfibrozil (Lopid). [85]
Belviq, Belviq XR (Lorcaserin)
Date of Approval: 2012
Date of Removal: February 13, 2020
Manufacturer: Eisai Inc.
Medical Use: 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.” [68][80]
Bextra(Valdecoxib)
Date of Approval: November 1, 2001
Date of Removal: April 7, 2005
Manufacturer: G.D. Searle & Co.
Medical Use: NSAID (pain relief)
Cause for Recall: serious cardiovascular adverse events (such as death, MI, stroke); increased risk of serious skin reactions (such as 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. [72]
Cylert (Pemoline)
Date of Approval: 1975
Date of Removal: October 2010
Manufacturer: Abbott Laboratories
Medical Use: 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. [49] [71]
Darvon & Darvocet (Propoxyphene)
Date of Approval: 1955
Date of Removal: November 19, 2010
Manufacturer: Xanodyne
Medical Use: opioid pain reliever
Cause for Recall: serious toxicity to the heart; between 1981 and 1999 there were more than 2,110 deaths reported. The U.K. banned Darvon & Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen. [74][91][101]
DBI (Phenformin)
Date of Approval: 1959
Date of Removal: November 1978
Manufacturer: Ciba-Geigy
Medical Use: antidiabetic
Cause for Recall: lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes
DES (Diethylstibestrol)
Date of Approval: 1940
Date of Removal: 1971
Manufacturer: Grant Chemical Co.
Medical Use: 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. [87][93]
Duract (Bromfenac)
Date of Approval: July 1997
Date of Removal: June 26, 1998
Manufacturer: Wyeth-Ayerst Laboratories
Medical Use: 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 or took more than ten days’ worth of pills; all cases of death and liver damage involved patients taking pills for longer than ten days. [76][103]
Ergamisol (Levamisole)
Date of Approval: May 8, 1989
Date of Removal: 2000
Manufacturer: Janssen Pharmaceutica
Medical Use: 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 U.S. It has also been found in street cocaine as an adulterant to increase euphoric qualities. [55][96]
Hismanal (Astemizole)
Date of Approval: 1988
Date of Removal: August 13, 1999
Manufacturer: Janssen Pharmaceutica
Medical Use: 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)
Date of Approval: February 9, 2000
Date of Removal: November 28, 2000
Manufacturer: Prometheus Laboratories, Inc.
Medical Use: 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 U.S. market in 2002 with restricted indication. [62] [108][90]
Meridia (Sibutramine)
Date of Approval: November 1997
Date of Removal: October 2010
Manufacturer: Knoll Pharmaceuticals
Medical Use: appetite suppressant
Cause for Recall: increased cardiovascular and stroke risk. In September 30, 2004, testimony before a U.S. Senate committee, FDA reviewer 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, calling the drugs “another Vioxx.”
Merital & Alival (Nomifensine)
Date of Approval: 1982
Date of Removal:
Manufacturer: Hoechst AG
Medical Use: antidepressant
Cause for Recall: haemolytic anemia; some deaths due to immunohemolytic anemia
Micturin (Terodiline)
Date of Approval: August 1989
Date of Removal: September 13, 1991
Manufacturer: Forest Labs
Medical Use: bladder incontinence
Cause for Recall: QT prolongation and potential for cardiotoxicity
Mylotarg (Gemtuzumab Ozogamicin)
Date of Approval: May 2000
Date of Removal: June 21, 2010
Manufacturer: Wyeth-Ayerst Laboratories
Medical Use: acute myeloid leukemia (AML; a bone marrow cancer)
Cause for Recall: increased risk of death and veno-occlusive disease (obstruction of veins) [65]
Omniflox (Temafloxacin)
Date of Approval: January 31, 1992
Date of Removal: June 5, 1992
Manufacturer: Abbott Laboratories
Medical Use: antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments
Cause for Recall: three deaths; severe 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. [79][94]
Palladone (Hydromorphone hydrochloride, extended-release)
Date of Approval: January 2005
Date of Removal: July 13, 2005
Manufacturer: Purdue Pharma
Medical Use: 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. [75]
Permax (Pergolide)
Date of Approval: 1988
Date of Removal: March 29, 2007
Manufacturer: Valeant
Medical Use: Parkinson’s disease
Cause for Recall: heart 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. [61][84]
Pondimin (Fenfluramine)
Date of Approval: 1973
Date of Removal: September 15, 1997
Manufacturer: Wyeth-Ayerst
Medical Use: appetite suppressant
Cause for Recall: 30 percent 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. [60] [77]
Posicor (Mibefradil)
Date of Approval: June 1997
Date of Removal: June 1998
Manufacturer: Roche Laboratories
Medical Use: calcium channel blocker (used to treat hypertension)
Cause for Recall: fatal interactions with at least 25 other drugs (e.g., common antibiotics, antihistamines, cancer, and cholesterol drugs), including astemizole, cisapride, terfenadine, lovastatin, and simvastatin. Posicor was found by the FDA to offer no significant benefit over other antihypertensive 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. [102]
Propulsid (Cisapride)
Date of Approval: 1993
Date of Removal: July 14, 2000
Manufacturer: Janssen Pharmaceutica
Medical Use: 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) but is available for limited use in Europe. It is still available for use in animals in the U.S. and Canada. [73]
PTZ and Metrazol (Pentylenetetrazol)
Date of Approval: 1934
Date of Removal: 1982
Manufacturer: unknown
Medical Use: convulsive therapy for schizophrenia and other psychiatric conditions
Cause for Recall: uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42 percent of patients. [58]
Quaalude (Methaqualone)
Marketed as Optimal, Sopor, Parest, Somnafac, and Bi-Phetamine T
Date of Approval: 1962
Date of Removal: 1985
Manufacturer: William H. Rorer Inc. & Lemmon Company
Medical Use: 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)
Date of Approval: 1999
Date of Removal: March 27, 2001
Manufacturer: Organon Inc.
Medical Use: nonpolarizing neuromuscular blocker (used in anesthesia)
Cause for Recall: bronchospasms and unexplained deaths [78]
Raptiva (Efalizumab)
Date of Approval: 2003
Date of Removal: April 8, 2009 (not completely withdrawn until June 8, 2009)
Manufacturer: Genentech
Medical Use: 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). [70]
Raxar (Grepafloxacin)
Date of Approval: 1997
Date of Removal: November 1, 1999
Manufacturer: Glaxo Wellcome
Medical Use: antibiotic for bacterial infections
Cause for Recall: cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes) [81]
Redux (Dexfenfluramine)
Date of Approval: 1996
Date of Removal: September 15, 1997
Manufacturer: Wyeth-Ayerst
Medical Use: appetite suppressant
Cause for Recall: 30 percent 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. [60][77]
Rezulin (Troglitazone)
Date of Approval: January 29, 1997
Date of Removal: March 21, 2000
Manufacturer: Parke-Davis/Warner Lambert
Medical Use: 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. [83][107]
Selacryn (Tienilic acid)
Date of Approval: May 2, 1979
Date of Removal: 1982
Manufacturer: SmithKline
Medical Use: 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 the U.S. to SmithKline) sent a report to SmithKline in April 1979 (translated in May 1979 into English from French) stating that Selacryn damaged livers. On December 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.” [51]
Seldane (Terfenadine)
Date of Approval: 1985
Date of Removal: February 1, 1998
Manufacturer: Hoechst Marion Roussel
Medical Use: 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. [54]
Trasylol (Aprotinin)
Date of Approval: 1993 (used without FDA approval since the 1960s)
Date of Removal: November 5, 2007 (marketing suspension request to phase it out of the market); May 14, 2008 (manufacturer announced complete removal from the market)
Manufacturer:Bayer
Medical Use: antifibrinolytic to reduce blood loss during surgery
Cause for Recall: increased chance of death, serious kidney damage, congestive heart failure, and strokes. On February 8, 2006, the FDA issued a public heath advisory to surgeons who perform heart bypasses, alerting them to possible fatal side effects. [64][65]
Vioxx (Rofecoxib)
Date of Approval: May 20, 1999
Date of Removal: September 30, 2004
Manufacturer: Merck
Medical Use: 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)
Date of Approval: November 2001
Date of Removal: October 25, 2011
Manufacturer: Eli Lilly & Company
Medical Use: severe sepsis and septic shock
Zantac (Ranitidine)
Date of Approval: 1983 (prescription), 2004 (over the counter)
Date of Removal: April 2021
Manufacturer: Sanofi
Medical Use: 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).” [67][98]
Zelmid (Zimelidine)
Date of Approval: 1982
Date of Removal: 1982 (withdrawn by the FDA before being released in the U.S. market)
Manufacturer: Astra AB
Medical Use: antidepressant
Cause for Recall: Guillain–Barré syndrome; higher risk of suicide
Zelnorm (Tegaserod maleate)
Date of Approval: July 24, 2002
Date of Removal: March 30, 2007
Manufacturer: Novartis
Medical Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than age 55
Cause for Recall: higher chance of heart attack, stroke, and unstable angina (heart or 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. [50][82]
1-minute Survey
After reading this debate, take our quick survey to see how this information affected your opinion of this topic. We appreciate your feedback.
Discussion Questions
- Should the U.S. government regulate prescription drug prices? Why or why not?
- Should prescription drug prices be regulated by any governing body, or should drug manufacturers be allowed to set prices? Explain your answer.
- Should any other regulations be imposed upon prescription drug pricing? Explain your answer.
Take Action
- Consider policy reform suggestions from the Commonwealth Fund.
- Using Investopedia, analyze how pharmaceutical companies price drugs.
- Explore the con argument from David A. Ricks, the CEO of the drug company Eli Lilly and Company.
- Consider how you felt about the issue before reading this article. After reading the pros and cons on this topic, has your thinking changed? If so, how? List two to three ways. If your thoughts have not changed, list two to three ways your better understanding of the other side of the issue now helps you better argue your position.
- Push for the position and policies you support by writing U.S. senators and representatives.
Sources
- Paul B. Ginsburg and Steven M. Lieberman, “Government Regulated or Negotiated Drug Prices: Key Design Considerations,” brookings.edu, August 30, 2021
- “Prescription Drug,” merriam-webster.com (accessed March 29, 2022)
- Randa Hilal-Dandan and Laurence L. Brunton, “Appendix I: Principles of Prescription Order Writing and Patient Compliance,” in Goodman and Gilman’s Manual of Pharmacology and Therapeutics, 2nd edition, accesspharmacy.mhmedical.com, 2014
- Julia Hawley, “How Pharmaceutical Companies Price Their Drugs,” investopedia.com, March 21, 2022
- Melissa Pistilli, “10 Top Pharma Companies by Revenue,” investingnews.com, December 09, 2021
- Drug Discovery & Development, “Pharma 50: The 50 Largest Pharmaceutical Companies in the World,” drugdiscoverytrends.com (accessed March 30, 2022)
- “Evaluate Pharma World Preview 2020, Outlook to 2026,” evaluate.com, July 16, 2020
- American Medical Association, “How Are Prescription Drug Prices Determined?,” ama-assn.org, April 9, 2019
- “Pharmacy Benefit Managers and Their Role in Drug Spending,” commonwealthfund.org, April 22, 2019
- Sonya Collins, “Most Physicians Unable to Estimate Patients’ Out-of-Pocket Costs: How Pharmacists Can Help,” pharmacytoday.org, March 1, 2022
- Rand Corporation, “Prescription Drug Prices in the United States Are 2.56 Times Those in Other Countries,” rand.org, January 28, 2021
- Juliette Cubanski, Tricia Neuman, and Meredith Freed, “Explaining the Prescription Drug Provisions in the Build Back Better Act,” kff.org, November 23, 2021
- Barbara Sprunt, “House Passes Bill to Cap Insulin Prices,” npr.org, March 31, 2022
- Margot Sanger-Katz, “House Passes Bill to Limit Cost of Insulin to $35 a Month,” nytimes.com, March 31, 2022
- Kaiser Family Foundation, “Poll: Nearly 1 in 4 Americans Taking Prescription Drugs Say It’s Difficult to Afford Their Medicines, Including Larger Shares Among Those with Health Issues, with Low Incomes and Nearing Medicare Age,” kff.org, March 1, 2019
- Paul Brandus, “Opinion: Food or Medication? The Dangerous Choice Many Seniors Have to Make,” marketwatch.com, March 26, 2021
- Healio Internal Medicine, “Nearly Half of Americans Forgo Medical Care Because of Cost,” healio.com, March 27, 2018
- Truth in Rx, “Price Hikes and Secret Deals,” truthinrx.org (accessed March 29, 2022)
- Darrell Hulisz, The Soaring Price of EpiPen,” rn.com (accessed March 31, 2022)
- Emily Willingham, “Why Did Mylan Hike EpiPen Prices 400 percent? Because They Could,” forbes.com, Aug 21, 2016
- Cynthia Koons and Robert Langreth, “How Marketing Turned the EpiPen into a Billion-Dollar Business,” bloomberg.com, September 23, 2015
- Wayne Drash, “Anatomy of a 97,000 percent Drug Price Hike: One Family’s Fight to Save Their Son,” cnn.com, June 29, 2018
- Heather Long and Matt Egan, “Meet the Guy Behind the $750 AIDS Drug,” money.cnn.com, September 22, 2015
- Surescripts, “Data Brief: Physician Perspectives on Access to Patient Data,” surescripts.com, April 2018
- Jules Lipoff, “Expensive Prescriptions Have Patients Skipping Their Meds. What Can Doctors Do About It?,” statnews.com, April 3, 2018
- Congressional Budget Office, “Research and Development in the Pharmaceutical Industry,” cbo.gov, April 2021
- Joe Kennedy, “The Link Between Drug Prices and Research on the Next Generation of Cures,” itif.org, September 9, 2019
- “What Are the Average Research and Development Costs for Pharmaceutical Companies?,” investopedia.com, March 11, 2022
- David A. Ricks, “The Risks of Government Negotiation of Drug Prices,” bostonglobe.com, October 25, 2021
- Jake Ellison, “Drug Rebates for Insurers Tied to Higher Costs for Patients, Especially the Uninsured,” washington.edu, June 15, 2021
- Kai Yeung, Stacie B. Dusetzina, and Anirban Basu, “Association of Branded Prescription Drug Rebate Size and Patient Out-of-Pocket Costs in a Nationally Representative Sample, 2007–2018,” jamanetwork.com, June 14, 2021
- Cornell Law School Legal Information Institute, “45 CFR § 156.122 - Prescription Drug Benefits,” law.cornell.edu (accessed June 6, 2022)
- Chip Davis, “It’s Up to Congress to Make Life-Saving Drugs Affordable,” cnn.com, February 8, 2018
- Tom Coburn, “Free Market, Better Medicine,” usnews.com, February 15, 2018
- Jake Novack, “Trump’s Losses in Drug Pricing Battle Should Be a Free Market Wake-Up Call to Him,” cnbc.com, July 11, 2019
- Jacob James Rich, “It’s Time to Free the Pharmaceutical Market from Government Control,” reason.org, April 3, 2020
- Ken Alltucker, “Struggling to Stay Alive: Rising Insulin Prices Cause Diabetics to Go to Extremes,” usatoday.com, March 21, 2019
- Kristin Fraser, “Why Americans Are Getting Their Insulin from Mexico,” vice.com, July 21, 2019
- Emily Kopp, “Nonprofit Working to Block Drug Imports Has Ties to Pharma Lobby,” npr.org, March 18, 2017
- Bram Sable-Smith, “American Travelers Seek Cheaper Prescription Drugs in Mexico and Beyond,” npr.org, February 11, 2019
- Public Employees Health Program, “Pharmacy Tourism Program,” pehp.org (accessed April 5, 2022)
- Erin Alberty, “Prescriptions from Mexico? Utah Is Paying Public Employees to Make the Trip,” sltrib.com, January 5, 2020
- Nisha Kurani, Dustin Cotliar, and Cynthia Cox, “How Do Prescription Drug Costs in the United States Compare to Other Countries?,” healthsystemtracker.org, February 8, 2022
- Sydney Lupkin, “FDA Approves Florida’s Plan to Import Cheaper Drugs from Canada,” npr.org, January 5, 2024
- The Canadian Press, “Move to Allow Canadian Drugs to Be Imported by U.S. Creates Shortage Fears,” ctvnews.ca, January 5, 2024
- “FDA Authorizes Florida’s Drug Importation Program,” fda.gov, January 5, 2024
- FDA, “Importation Program Under Section 804 of the FD&C Act,” fda.gov, January 5, 2024
- Nisha Kurani, Dustin Cotliar, and Cynthia Cox, “How Do Prescription Drug Costs in the United States Compare to Other Countries?,” healthsystemtracker.org, February 8, 2022
- Abbott Laboratories, “Cylert,” American Journal of Diseases of Children, bonkersinstitute.org, 1976
- “Zelnorm—‘N/A’—Deutsch NY,” adforum.com (accessed February 7, 2014)
- Associated Press, “Drug Maker Pleads Guilty over Lethal Side Effects,” nytimes.com, December 14, 1984
- Wei Zhang, et al., “Pharmacogenetics of Drugs Withdrawn from the Market,” Pharmacogenomics, medscape.com, 2012
- Michelle R. Carter and Sorour Amirhaeri, “p-ANCA-Associated Vasculitis Caused by Levamisole-Adulterated Cocaine: A Case Report,” Case Reports in Emergency Medicine, hindawi.com, 2013
- Marlene Cimons, “Seldane Pulled for a Safer Allergy Drug,” latimes.com, December 30, 1997
- Dan Collins, “Insider: FDA Won’t Protect Public,” cbsnews.com, December 7, 2004
- Richard DeGrandpre, The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture, 2006
- “Drugs: The Dangers of Analgesics,” time.com, February 24, 1967
- Fairfield State Hospital, “Metrazol Therapy,” fairfieldstatehospital.com, January 15, 2013
- “FDA Alerts Consumers of Undeclared Drug Ingredients in Over-the-Counter Diabetes Product,” fda.gov, July 23, 2013
- “FDA Announces Withdrawal [of] Fenfluramine and Dexfenfluramine (Fen-Phen),” fda.gov, September 15, 1997
- “FDA Announces Voluntary Withdrawal of Pergolide Products: Agency Working with Product Manufacturers,” fda.gov, March 29, 2007
- FDA, “FDA Approves First Treatment for Women with Constipation-Predominant Irritable Bowel Syndrome,” web.archive.org, July 24, 2002
- “FDA Drug Safety Communication: Voluntary Market Withdrawal of Xigris [Drotrecogin Alfa (Activated)] Due to Failure to Show a Survival Benefit,” fda.gov, October 25, 2011
- “FDA Issues Public Health Advisory for Trasylol,” fda.gov, February 8, 2006
- “FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market,” fda.gov, June 21, 2010
- “FDA Requests Marketing Suspension of Trasylol,” fda.gov, November 5, 2007
- “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market,” fda.gov, April 1, 2020
- “FDA Requests the Withdrawal of the Weight-Loss Drug Belviq, Belviq XR (Lorcaserin) from the Market,” fda.gov, February 13, 2020
- “How Does FDA Decide When a Drug Is Not Safe Enough to Stay on the Market?,” fda.gov, January 7, 2010
- “FDA Statement on the Voluntary Withdrawal of Raptiva from the U.S. Market,” fda.gov, April 8, 2009
- “Information for Healthcare Professionals: Pemoline Tablets and Chewable Tablets (Marketed as Cylert),” fda.gov, October 2005
- “Information for Healthcare Professionals: Valdecoxib (Marketed as Bextra),” fda.gov, April 7, 2005
- “Propulsid (Cisapride) Dear Healthcare Professional Letter Jan 2000,” fda.gov, Jan 24, 2000
- “Propoxyphene: Withdrawal—Risk of Cardiac Toxicity,” fda.gov, November 19, 2010
- “Public Health Advisory: Suspended Marketing of Palladone (Hydromophone Hydrocloride, Extended-Release Capsules),” fda.gov, July 13, 2005
- “Questions and Answers About Withdrawal of Duract,” fda.gov, August 23, 2013
- “Questions and Answers about Withdrawal of Fenfluramine (Pondimine) and Dexfenfluramine (Redux),” fda.gov, July, 7, 2005
- “Raplon (Rapacuronium Bromide),” fda.gov, March 29, 2001
- “Recalling the Omniflox (Temafloxacin) Tablets,” fda.gov, June 5, 1992
- “Safety Clinical Trial Shows Possible Increased Risk of Cancer with Weight-Loss Medicine Belviq, Belviq XR (Lorcaserin),” fda.gov, January 14, 2020
- “Withdrawal of Product: RAXAR (Grepafloxin HCL) 600 mg Tablets, 400 mg Tablets, and 200 mg Tablets,” fda.gov, November 1, 1999
- “Zelnorm (Tegaserod Maleate) Information,” fda.gov, May 11, 2012
- Jef Feeley, “Pfizer Ends Rezulin Cases with $205 Million to Spare (Update1),” bloomberg.com, March 31, 2009
- Barbara Forney, “Pergolide for Veterinary Use,” wedgewoodpetrx.com (accessed January 6, 2014)
- Curt D. Furgerg and Bertram Pitt, “Withdrawal of Cerivastatin from the World Market,” ncbi.nlm.nih.gov, September 26, 2001
- Raymond Goldberg, Drugs Across the Spectrum, 6th edition, 2010
- 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, medscape.com, 2003
- David Healy, Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression, 2004
- Charles D. Helper and Richard Segal, Preventing Medication Errors and Improving Drug Therapy Outcomes: A Management Systems Approach, 2003
- Irritable Bowel Syndrome Self Help and Support Group, “Lotronex,” ibsgroups.org (accessed January 6, 2014)
- Harvey Kirk, “Darvon and Darvocet Deaths Lead FDA Panel to Recommend Recall,” youhavealawyer.com, February 2, 2009
- “Lilly Announces Withdrawal of Xigris R Following Recent Clinical Trial Results,” fda.gov, October 25, 2011
- National Cancer Institute, “Diethylstilbestrol (DES) and Cancer,” cancer.gov, October 5, 2011
- Steven Morris, “Abbott Gets FDA Approval for Omniflox Antibiotic,” chicagotribune.com, February 1, 1992
- MSNBC, “Report: Vioxx Linked to Thousands of Deaths,” nbcnews.com, October 6, 2004
- Pink Sheet, “FDA Clears Treatment IND for Colon Cancer Drug Levamisole,” elsevierbi.com, May 15, 1989
- Res Obscura, “From Quacks to Quaaludes: Three Centuries of Drug Advertising,” resobscura.blogspot.nl, June 11, 2012
- “Timeline: Popular Heartburn Medicine Zantac Pulled off Store Shelves,” reuters.com, October 21, 2019
- Rita Rubin, “How Did Vioxx Debacle Happen?,” usatoday.com, October 12, 2004
- Renato M.E. Sabbatini, “The History of Shock Therapy in Psychiatry,” crerbromente.org.br (accessed December 19, 2013)
- Christian Sinclair, “Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?,” pallimed.org, November 30, 2010
- Ruth SoRelle, “Withdrawal of Posicor from Market,” circ.ahajournals.org, 1998
- Sheryl Gay Stolberg, “New Painkiller Is Withdrawn After 4 Deaths,” nytimes.com, June 23, 1998
- 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,” sfgate.com, February 27, 2005
- Forest Tennant, “Hughes & Pseudoaddiction,” Practical Pain Management, pain-topics.org, July/August 2007
- “This Is Patient Education?,” todaysseniorsnetwork.com (accessed January 7, 2014)
- David Willman, “Diabetes Drug Rezulin Pulled off the Market,” pulitzer.org, March 22, 2000
- David Willman, “Drug Lotronex Pulled over Safety Fears,” pulitzer.org, November 29, 2000
- Wei Zhang et al., “Pharmacogenetics of Drugs Withdrawn from the Market,” Pharmacogenomics, medscape.com, 2012
- Juliana Kim and Sydney Lupkin, “FTC Sues Insulin Middlemen, Saying They Pocket Billions While Patients Face High Costs,” npr.org, September 22, 2024
- Victoria K. Hamscho, “Federal Courts Block Implementation of Most Favored Nation Drug Pricing Rule” (December 29, 2020), klgates.com
- Centers for Medicare & Medicaid Services, “Most Favored Nation (MFN) Model” (November 27, 2020), federalregister.gov
- Berkeley Lovelace Jr., “Trump Signs Executive Order That Aims to Slash Drug Prices by at Least 50%” (May 12, 2025), nbcnews.com
- White House, “Fact Sheet: President Donald J. Trump Announces Actions to Put American Patients First by Lowering Drug Prices and Stopping Foreign Free-riding on American Pharmaceutical Innovation” (May 12, 2015), whitehouse.gov
- White House, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (May 12, 2025), whitehouse.gov