The FDA is tasked with ensuring the safety and efficacy of products, but history shows that some approvals have been followed by significant safety concerns, recalls, or withdrawals. Below are 40 examples of products that arguably should not have been approved or were later deemed problematic.
1. Phenylpropanolamine (PPA)
An ingredient in cold medicines and weight-loss products, linked to increased risk of hemorrhagic stroke and withdrawn in 2005.
2. Vioxx (Rofecoxib)
Approved in 1999 for pain relief, Vioxx was withdrawn in 2004 after studies showed it significantly increased the risk of heart attacks and strokes. Critics argued that the FDA ignored early warning signs.
3. Fen-Phen (Fenfluramine/Phentermine)
A weight-loss drug combination approved in the 1990s, Fen-Phen was linked to heart valve damage and pulmonary hypertension. It was withdrawn in 1997.
4. Avandia (Rosiglitazone)
Approved in 1999 for diabetes, Avandia was later found to increase the risk of heart attacks. The FDA restricted its use in 2010, though it remains on the market with limitations.
5. Bextra (Valdecoxib)
A COX-2 inhibitor like Vioxx, Bextra was approved in 2001 for pain relief but was withdrawn in 2005 due to increased risks of heart attacks, strokes, and severe skin reactions.
6. Zicam Nasal Gel
Marketed as a cold remedy, Zicam was linked to anosmia (loss of smell) in users. The FDA issued a warning in 2009, and the product was withdrawn, though it later returned with modified labeling.
7. Darvon and Darvocet (Propoxyphene)
Approved in the 1950s for pain relief, these drugs were linked to serious heart rhythm abnormalities and overdose risks. The FDA withdrew approval in 2010 after decades of use.
8. Essure (Permanent Birth Control Device)
Approved in 2002, Essure was a non-surgical sterilisation device. It was later linked to severe complications, including chronic pain, perforations, and autoimmune reactions. It was pulled from the market in 2018.
9. Opioid Painkillers (e.g., OxyContin)
While opioids have legitimate medical uses, critics argue that the FDA’s approval and labeling of drugs like OxyContin contributed to the opioid epidemic by underestimating addiction risks and overstating benefits for chronic pain.
10. Trovan (Trovafloxacin)
Approved in 1997, this antibiotic was linked to severe liver damage and was withdrawn in 1999. Critics questioned why the FDA approved it despite known risks.
11. Meridia (Sibutramine)
A weight-loss drug approved in 1997, Meridia was withdrawn in 2010 after studies showed it increased the risk of heart attacks and strokes.
12. Rezulin (Troglitazone)
Approved in 1997 for type 2 diabetes, Rezulin was withdrawn in 2000 after being linked to severe liver damage and liver failure.
13. Palladone (Hydromorphone)
A potent opioid approved in 2004 for chronic pain, Palladone was withdrawn in 2005 due to the risk of fatal overdose when taken with alcohol.
14. Seldane (Terfenadine)
An antihistamine approved in 1985 for allergies, Seldane was withdrawn in 1998 after it was found to cause dangerous heart arrhythmias when taken with certain medications.
15. Baycol (Cerivastatin)
A cholesterol-lowering drug approved in 1997, Baycol was withdrawn in 2001 after being linked to severe muscle damage (rhabdomyolysis) and kidney failure.
16. Raptiva (Efalizumab)
Approved in 2003 for psoriasis, Raptiva was withdrawn in 2009 after it was linked to an increased risk of a rare and often fatal brain infection (PML).
17. Zelnorm (Tegaserod)
Approved in 2002 for irritable bowel syndrome (IBS), Zelnorm was withdrawn in 2007 after studies showed it increased the risk of heart attacks and strokes.
18. Lotronex (Alosetron)
Approved in 2000 for IBS in women, Lotronex was withdrawn later that year after being linked to severe gastrointestinal side effects, including ischemic colitis. It was later reintroduced with “strict” warnings.
19. Tysabri (Natalizumab)
Approved in 2004 for multiple sclerosis and Crohn’s disease, Tysabri was temporarily withdrawn in 2005 after being linked to a brain infection (PML). It was later reintroduced with a risk management programme.
20. Pergolide (Permax)
Approved in 1988 for Parkinson’s disease, Pergolide was withdrawn in 2007 after studies confirmed it increased the risk of heart valve damage.
21. Propulsid (Cisapride)
Approved in 1993 for heartburn and gastroesophageal reflux disease (GERD), Propulsid was withdrawn in 2000 after being linked to severe heart rhythm abnormalities and multiple deaths.
22. Duract (Bromfenac)
A painkiller approved in 1997 for short-term use, Duract was withdrawn in 1998 after reports of severe liver damage and liver failure in patients who used it longer than recommended.
23. Raplon (Rapacuronium)
Approved in 1999 as a muscle relaxant for use during surgery, Raplon was withdrawn in 2001 after it was linked to severe bronchospasm and several deaths.
24. Posicor (Mibefradil)
Approved in 1997 for high blood pressure and chronic angina, Posicor was withdrawn in 1998 due to dangerous interactions with other drugs, leading to life-threatening side effects.
25. Xigris (Drotrecogin alfa)
Approved in 2001 for severe sepsis, Xigris was withdrawn in 2011 after studies showed it failed to improve survival and posed risks of serious bleeding.
26. Redux (Dexfenfluramine)
Approved in 1996 for weight loss, Redux was withdrawn in 1997 after being linked to heart valve damage and pulmonary hypertension, similar to Fen-Phen.
27. Hismanal (Astemizole)
An antihistamine approved in 1988 for allergies, Hismanal was withdrawn in 1999 due to dangerous heart rhythm abnormalities and interactions with other drugs.
28. Raxar (Grepafloxacin)
An antibiotic approved in 1997, Raxar was withdrawn in 1999 after being linked to serious heart rhythm disturbances.
29. Tequin (Gatifloxacin)
Approved in 1999 as an antibiotic, Tequin was withdrawn in 2006 due to risks of severe blood sugar disturbances, including life-threatening hyperglycemia and hypoglycemia.
30. Trasylol (Aprotinin)
Approved in 1993 to reduce bleeding during heart surgery, Trasylol was withdrawn in 2008 after studies showed it increased the risk of kidney failure, heart attacks, and death.
31. Zomax (Zomepirac)
A painkiller approved in 1980, Zomax was withdrawn in 1983 after being linked to severe allergic reactions, including anaphylaxis and deaths.
32. Omniflox (Temafloxacin)
An antibiotic approved in 1992, Omniflox was withdrawn just six months later due to severe side effects, including haemolytic anemia and liver and kidney damage.
33. Pondimin (Fenfluramine)
Approved in 1973 for weight loss, Pondimin was withdrawn in 1997 as part of the Fen-Phen combination due to heart valve damage and pulmonary hypertension.
34. Remicade (Infliximab)
Approved in 1998 for autoimmune diseases, Remicade has faced ongoing scrutiny over its risks of serious infections, lymphoma, and heart failure, though it remains on the market with warnings.
35. Accutane (Isotretinoin)
Approved in 1982 for severe acne, Accutane has been linked to severe birth defects, depression, and suicidal behaviour. It was withdrawn in 2009, but generic versions remain available under strict monitoring programmes.
36. Vanutide (Cridanimod)
Approved in 1996 for genital warts, Vanutide was withdrawn in 1998 after reports of severe allergic reactions and lack of proven efficacy.
37. Phenylpropanolamine (PPA)
An ingredient in cold medicines and weight-loss products, PPA was linked to an increased risk of hemorrhagic stroke. The FDA requested its removal from all products in 2005.
38. Mylotarg (Gemtuzumab Ozogamicin)
Approved in 2000 for acute myeloid leukemia, Mylotarg was withdrawn in 2010 due to safety concerns, including severe liver damage and a lack of proven survival benefits. It was later reapproved in 2017 with “stricter” guidelines.
39. Tracleer (Bosentan)
Approved in 2001 for pulmonary arterial hypertension, Tracleer has faced scrutiny over risks of liver damage and birth defects. It remains on the market with a black box warning.
40. Pradaxa (Dabigatran)
Approved in 2010 as a blood thinner, Pradaxa has been linked to severe and sometimes fatal bleeding events. While it remains on the market, it has prompted lawsuits and increased scrutiny over its safety profile.
These examples highlight the reality that just because something is “approved” by the FDA, that doesn’t mean it is safe for you to use. This underscores the importance of ongoing monitoring, informed decision-making, and caution when using any medication or medical device.
References
FDA Thalidomide History: https://www.fda.gov
Drug Safety Information – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/index-drug-specific-information
Vioxx – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/cox-2-selective-includes-bextra-celebrex-and-vioxx-and-non-selective-non-steroidal-anti-inflammatory
NIH Study on Vioxx Risks: https://www.nih.gov
New England Journal of Medicine on Fen-Phen: https://www.nejm.org
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-ongoing-review-avandia-rosiglitazone-and-cardiovascular-safety
Information Page: FDA requires removal of certain restrictions on the diabetes drug Avandia – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-page-fda-requires-removal-certain-restrictions-diabetes-drug-avandia
Some Homeopathic Products May Put You at Risk – https://www.fda.gov/drugs/understanding-over-counter-medicines/some-homeopathic-products-may-put-you-risk
Darvon – Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention – https://www.fda.gov/media/126835/download
Essure – Problems Reported with Essure – https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure
CDC Opioid Overdose Crisis: https://www.cdc.gov
Public Statement on Trovan / Trovan IV / Turvel / Turvel IV (Trovafloxacin/Alatrofloxacin) recommendation to suspend the marketing authorisation in the European Union – https://www.ema.europa.eu/en/news/public-statement-trovan-trovan-iv-turvel-turvel-iv-trovafloxacin-alatrofloxacin-recommendation-suspend-marketing-authorisation-european-union
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-healthcare-professionals-hydromorphone-hydrochloride-extended-release-capsules-marketed
https://www.fda.gov/about-fda/fda-history-exhibits/drug-therapeutics-regulation-us
https://www.fda.gov/search
https://www.fda.gov/media/89003/download
Raptiva – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/efalizumab-marketed-raptiva-information
Raptiva – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-statement-voluntary-withdrawal-raptiva-us-market
Lotronex – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/lotronex-alosetron-hydrochloride-information
Lotronex – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/letter-regarding-lotronex-dr-janet-woodcock-director-center-drug-evaluation-and-research-12182000
Tysabri – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-risk-progressive-multifocal-leukoencephalopathy-pml-use-tysabri
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf
Lotronex – https://www.fda.gov/media/74177/download
Perolide – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/pergolide-marketed-permax-information
Propulsid – https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions
Duract – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/duract-bromfenac-information
Duract – http://wayback.archive-it.org/7993/20161022204806/http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm073043.htm
Raplon – https://www.fda.gov/media/71700/download
Posicor – https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions
Xigris – https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-voluntary-market-withdrawal-xigris-drotrecogin-alfa-activated-due
Redux – https://www.fda.gov/media/92861/download
A Brief History of the Center for Drug Evaluation and Research – https://www.fda.gov/about-fda/fda-history-exhibits/brief-history-center-drug-evaluation-and-research
Hismanal – https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions
Regulatory Science in Action-Enhancing Drug Safety & Manufacturing Quality at FDA with Research (PDF – 17.6MB) – https://www.fda.gov/media/123667/download
Raxar – Preventable Adverse Drug Reactions: A Focus on Drug Interactions – https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions
Tequin – Gatifloxacin (marketed as Tequin) Information -https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/gatifloxacin-marketed-tequin-information
Aprotinin Injection (marketed as Trasylol) Information – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aprotinin-injection-marketed-trasylol-information
Zomax – FDA Oral History Interview, Robert C. Wetherell – https://www.fda.gov/media/80982/download
Pondimin – htt ps://www.fda.gov/media/158280/download
Remicade – FDA approves Inflectra, a biosimilar to Remicade – https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade
Accutane – Introduction 2003 – https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story-archive/introduction-2003
Isotretinoin Capsule Information – https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/isotretinoin-capsule-information
FDA’s Role in Managing Medication Risks – https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/fdas-role-managing-medication-risks
Phenylpropanolamine – Science Background – Safety of Phenylpropanolamine – https://www.fda.gov/drugs/information-drug-class/science-background-safety-phenylpropanolamine
FDA approves Mylotarg for treatment of acute myeloid leukemia – https://www.fda.gov/news-events/press-announcements/fda-approves-mylotarg-treatment-acute-myeloid-leukemia
2010 Notifications – https://www.fda.gov/drugs/resources-information-approved-drugs/2010-notifications
Tracleer – CanaRx Services Inc – 554740 – 02/26/2019 – https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/canarx-services-inc-554740-02262019
April – June 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) – https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/april-june-2016-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event
FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules – https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-special-storage-and-handling-requirements-must-be-followed-pradaxa
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