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:
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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https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19
https://prescriptiondrugs.procon.org/fda-approved-prescription-drugs-later-pulled-from-the-market/
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? Its 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
FDA, “Raplon (Rapacuronium Bromide),” www.fda.gov, Mar. 29, 2001
FDA, “Recalling the Omniflox (Temafloxacin) Tablets,” June 5, 1992
FDA, “FDA Statement on the Voluntary Withdrawal of Raptiva from the U.S. Market,” www.fda.gov, Apr. 8, 2009
FDA, “Withdrawal of Product: RAXAR (grepafloxin HCL) 600 mg Tablets, 400 mg Tablets, and 200 mg Tablets,” www.fda.gov, Nov. 1, 1999
FDA, “Zelnorm (tegaserod maleate) Information,” www.fda.gov, May 11, 2012
Jef Feeley, “Pfizer Ends Rezulin Cases with $205 Million to Spare (Update1),” www.bloomberg.com, Mar. 31, 2009
Barbara Forney, “Pergolide for Veterinary Use,” www.wedgewoodpetrx.com (accessed Jan. 6, 2014)
Curt D. Furgerg and Bertram Pitt, “Withdrawal of Cerivastatin from the World Market,” www.ncbi.nlm.nih.gov, Sep. 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, www.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,” www.ibsgroups.org (accessed Jan. 6, 2014)
Harvey Kirk, “Darvon and Darvocet Deaths Lead FDA Panel to Recommend Recall,” www.youhavealawyer.com, Feb. 2, 2009
Lilly, “Lilly Announces Withdrawal of Xigris R Following Recent Clinical Trial Results,” www.fda.gov, Oct. 25, 2011
National Cancer Institute, “Diethylstilbestrol (DES) and Cancer,” www.cancer.gov, Oct. 5, 2011
Steven Morris, “Abbott Gets FDA Approval for Omniflox Antibiotic,” www.chicagotribune.com, Feb. 1, 1992
MSNBC Staff, “Report: Vioxx Linked to Thousands of Deaths,” www.nbcnews.com, Oct. 6, 2004
Pink Sheet, “FDA Clears Treatment IND for Colon Cancer Drug Levamisole,” www.elsevierbi.com, May 15, 1989
Res Obscura, “From Quacks to Quaaludes: Three Centuries of Drug Advertising,” www.resobscura.blogspot.nl, June 11, 2012
Rita Rubin, “How Did Vioxx Debacle Happen?,” www.usatoday.com, Oct. 12, 2004
Renato M.E. Sabbatini, “The History of Shock Therapy in Psychiatry,” www.crerbromente.org.br (accessed Dec. 19, 2013)
Christian Sinclair, “Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?,” www.pallimed.org, Nov. 30, 2010
Ruth SoRelle, “Withdrawal of Posicor from Market,” www.circ.ahajournals.org, 1998
Sheryl Gay Stolberg, “New Painkiller Is Withdrawn after 4 Deaths,” www.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,” www.sfgate.com, Feb. 27, 2005
Forest Tennant, “Hughes & Pseudoaddiction,” Practical Pain Management, www.pain-topics.org, July/Aug. 2007
Today’s Seniors Network, “This Is Patient Education?,” www.todaysseniorsnetwork.com (accessed Jan. 7, 2014)
David Willman, “Diabetes Drug Rezulin Pulled Off the Market,” www.pulitzer.org, Mar. 22, 2000
David Willman, “Drug Lotronex Pulled over Safety Fears,” www.pulitzer.org, Nov. 29, 2000
Wei Zhang, Mary W. Roederer, Wang-Qing Chen, Lan Fan, and Hong-Hao Zhou, “Pharmacogenetics of Drugs Withdrawn from the Market,” Pharmacogenomics, www.medscape.com, 2012
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