Wikipedia list of drugs pulled from the market in the US. This is not a complete list, but is the list of what they consider to be the most remarkable. There is one down on the left, Zelnorm. I am going to give you some details on that one.
But just for your interest, teratogenicity = developmental toxicity – thus a defect in development at some stage of life. The image of the 2 headed calf below is an example.
| Drug name | Withdrawn | Remarks |
|---|---|---|
| Thalidomide | 1950s–1960s | Withdrawn because of risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules |
| Lysergic acid diethylamide (LSD) | 1950s–1960s | Marketed as a psychiatric drug; withdrawn after it became widely used recreationally |
| Diethylstilbestrol | 1970s | Withdrawn because of risk of teratogenicity |
| Phenformin and Buformin | 1978 | Withdrawn because of risk of lactic acidosis |
| Ticrynafen | 1982 | Withdrawn because of risk of hepatitis |
| Zimelidine | 1983 | Withdrawn worldwide because of risk of Guillain-Barré syndrome |
| Phenacetin | 1983 | An ingredient in “A.P.C.” tablet; withdrawn because of risk of cancer and kidney disease |
| Methaqualone | 1984 | Withdrawn because of risk of addiction and overdose |
| Nomifensine (Merital) | 1986 | Withdrawn because of risk of hemolytic anemia |
| Triazolam | 1991 | Withdrawn in the United Kingdom because of risk of psychiatric adverse drug reactions. This drug continues to be available in the U.S. |
| Terodiline (Micturin) | 1991 | Prolonged QT interval |
| Temafloxacin | 1992 | Withdrawn in the United States because of allergic reactions and cases of hemolytic anemia, leading to three patient deaths.[1] |
| Flosequinan (Manoplax) | 1993 | Withdrawn in the United States because of an increased risk of hospitalization or death |
| Alpidem (Ananxyl) | 1995 | Not approved in the US, withdrawn in France in 1994[1]and the rest of the market in 1995 because of rare but serious hepatotoxicity.[2] |
| Chlormezanone (Trancopal) | 1996 | Withdrawn because of rare but serious cases of toxic epidermal necrolysis |
| Fen-phen (popular combination offenfluramine and phentermine) | 1997 | Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn as caused heart valve disorder |
| Tolrestat (Alredase) | 1997 | Withdrawn because of risk of severe hepatotoxicity |
| Terfenadine (Seldane, Triludan) | 1998 | Withdrawn because of risk of cardiac arrhythmias; superseded by fexofenadine |
| Mibefradil (Posicor) | 1998 | Withdrawn because of dangerous interactions with other drugs |
| Etretinate | 1990s | Risk of birth defects; narrow therapeutic index |
| Tolcapone (Tasmar) | 1998 | Hepatotoxicity |
| Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral) | 1999 | Withdrawn in Sweden and Norway because of diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the U.S., but under strict controls. |
| Astemizole (Hismanal) | 1999 | Arrhythmias because of interactions with other drugs |
| Grepafloxacin (Raxar) | 1999 | Prolonged QT interval |
| Levamisole (Ergamisol) | 1999 | Still used as veterinary drug; in humans was used to treat melanoma before it was withdrawn for agranulocytosis |
| Troglitazone (Rezulin) | 2000 | Withdrawn because of risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone |
| Alosetron (Lotronex) | 2000 | Withdrawn because of risk of fatal complications of constipation; reintroduced 2002 on a restricted basis |
| Cisapride (Propulsid) | 2000s | Withdrawn in many countries because of risk of cardiac arrhythmias |
| Amineptine (Survector) | 2000 | Withdrawn because of hepatotoxicity, dermatological side effects, and abuse potential. |
| Phenylpropanolamine (Propagest,Dexatrim) | 2000 | Withdrawn because of risk of stroke in women under 50 years of age when taken at high doses (75 mg twice daily) for weight loss. |
| Trovafloxacin (Trovan) | 2001 | Withdrawn because of risk of liver failure |
| Cerivastatin (Baycol, Lipobay) | 2001 | Withdrawn because of risk of rhabdomyolysis |
| Rapacuronium (Raplon) | 2001 | Withdrawn in many countries because of risk of fatal bronchospasm |
| Nefazodone | 2003 | Branded version withdrawn by originator in several countries in 2003, and in the US and Canada in 2004 for hepatotoxicity. Generic versions available. |
| Rofecoxib (Vioxx) | 2004 | Withdrawn because of risk of myocardial infarction |
| Co-proxamol (Distalgesic) | 2004 | Withdrawn in the UK due to overdose dangers. |
| mixed amphetamine salts (Adderall XR) | 2005 | Withdrawn in Canada because of risk of stroke. See Health Canada press release. The ban was later lifted because the death rate among those taking Adderall XR was determined to be no greater than those not taking Adderall. |
| hydromorphone extended-release (Palladone) | 2005 | Withdrawn because of a high risk of accidental overdose when administered with alcohol |
| Valdecoxib (Bextra) | 2005 | Withdrawn in US due to concerns about heart attack and stroke. |
| Thioridazine (Melleril) | 2005 | Withdrawn from U.K. market because of cardiotoxicity |
| Pemoline (Cylert) | 2005 | Withdrawn from U.S. market because of hepatotoxicity |
| Natalizumab (Tysabri) | 2005–2006 | Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006. |
| Ximelagatran (Exanta) | 2006 | Withdrawn because of risk of hepatotoxicity (liver damage). |
| Pergolide (Permax) | 2007 | Voluntarily withdrawn in the U.S. because of the risk of heart valve damage. Still available elsewhere. |
| Tegaserod (Zelnorm) | 2007 | Withdrawn because of imbalance of cardiovascular ischemic events, including heart attack and stroke. Was available through a restricted access program until April 2008. |
| Aprotinin (Trasylol) | 2007 | Withdrawn because of increased risk of complications or death; permanently withdrawn in 2008 except for research use |
| Inhaled insulin (Exubera) | 2007 | Withdrawn in the UK due to poor sales caused by national restrictions on prescribing, doubts over long term safety and too high a cost |
| Lumiracoxib (Prexige) | 2007–2008 | Progressively withdrawn around the world because of serious side effects, mainly liver damage |
| Rimonabant (Acomplia) | 2008 | Withdrawn around the world because of risk of severe depression and suicide |
| Efalizumab (Raptiva) | 2009 | Withdrawn because of increased risk of progressive multifocal leukoencephalopathy |
| Sibutramine (Reductil/Meridia) | 2010 | Withdrawn in Europe, Australasia, Canada, and the U.S. because of increased cardiovascular risk |
| Gemtuzumab ozogamicin (Mylotarg) | 2010 | Withdrawn in the U.S. due to increased risks of veno-occlusive disease and based on results of a clinical trial in which it showed no benefit in acute myeloid leukemia (AML) |
| Propoxyphene (Darvocet/Darvon) | 2010 | Withdrawn from worldwide market because of increased risk of heart attacks and stroke.[3] |
| Rosiglitazone (Avandia) | 2010 | Withdrawn in Europe because of increased risk of heart attacks and death. This drug continues to be available in the U.S. |
| Drotrecogin alfa (Xigris) | 2011 | Withdrawn by Lily worldwide following results of the PROWESS-SHOCK study that showed lack of efficacy. |
So the quick story on Zelnorm – the commercials were widely popular. People with words drawn on their stomachs about how bad they felt inside (irritable bowel, or other gastro-intestinal complaints). At the time it was the only prescription drug for these complaints, so it ran up the totem pole fast in total sales.
There were concerns about the approval of the drug, written about here on the Help for IBS website. See the gist:
Controversy over Zelnorm approval ~ A consumer advocacy group has attacked the FDA’s approval, claiming that officials were ignoring early signals of Zelnorm risks just as the agency earlier downplayed the bowel inflammations and other complaints that eventually derailed the IBS-diarrhea drug Lotronex. The advocacy group Public Citizen (a national non-profit organization that accepts no government or corporate money) contends that the approval of Zelnorm is a serious mistake by the FDA…
And of course in 2007 the drug is pulled from the market because they found in women especially, the risk of cardiovascular events was seriously inflated, 6 times the normal that is. Wikipedia’s page does a decent job of telling the story: The FDA alleges a relationship between prescriptions of the drug and increased risks of heart attack or stroke. An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%). Novartis alleges all of the affected patients had preexisting cardiovascular disease or risk factors for such, and further alleges that no causal relationship between tegaserod use and cardiovascular events has been demonstrated.[6] On the same day as the FDA announcement, Novartis Pharmaceuticals Canada announced that it was suspending marketing and sales of the drug in Canada in response to a request from Health Canada.[7]
What is the real point? 80% of our IBS patients have written testimonials at some point or another for our chiropractic care and dietary education. Ours, is important, because the focus is wellness, not feeling good. If you aren’t a believer yet, get your head out of the sand. This is not just for aches and pains, and as a matter of fact, it isn’t for that at all. Our job isn’t to make you feel well, its to get you functioning. No drugs. You know you want to be drug free, listen hard and stay the course.
If you haven’t been adjusted in the last week or two, get in here and get on track! The summer is no excuse. Be Blessed and Be Well! – Dr. E