List of FDA withdrawn drugs, for hurting People WRITEN BY LAIMA JONUSIENE MD To prove that the drug companies make mistakes with our lives we publish this list. Drugs are rushed onto the market for profit. The testing of the drugs is on the major indication. Side effects are NOT tested pre and post. Side effects are observed NOT tested. The expense of pre and post side effect testing is astounding. So it is not done. Side effects are then seen in the public use and a drug is removed from the market after killing or hurting people. There is a special law that prohibits you from suing a drug company for damages unless you can prove they knew it was harmful and sold it anyway. This means there is even less need to test side effects and or report them during the testing process. Some drugs have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical
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List of FDA withdrawn drugs,
for hurting People
WRITEN BY LAIMA JONUSIENE MD
To prove that the drug companies make mistakes with our lives we publish this list. Drugs are rushed onto the market for profit. The testing of the drugs is on the major indication. Side effects are NOT tested pre and post. Side effects are observed NOT tested. The expense of pre and post side effect testing is astounding. So it is not done. Side effects are then seen in the public use and a drug is removed from the market after killing or hurting people.
There is a special law that prohibits you from suing a drug company for damages unless you can prove they knew it was harmful and sold it anyway. This means there is even less need to test side effects and or report them during the testing process.
Some drugs have been withdrawn from the market because of risks to the patients. Usually this has been prompted by unexpected adverse effects that were not detected during Phase III clinical
trials and were only apparent from postmarketing surveillance data from the wider patient community.
This list is not limited to drugs that were ever approved by the FDA. Some of them (Lumiracoxib, Rimonabant, Tolrestat, Ximelagatran and Zimelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the U.S., when side effects became clear and their developers pulled them from the market. Likewise LSD was never approved for marketing in the U.S.
Significant withdrawals
Drug name
W i t d Remarks a
n
Thalidomide
1Withdrawn because of risk
5of teratogenicity; sreturned to market for use 1in leprosy and multiple
imbalance of cardiovascular ischemic events, including heart attack and stroke. Was available through a restricted access program until April 2008. Withdrawn because of increased risk
2of complications
0or death; permanently withdrawn in 2008 except for research use Withdrawn in the UK due to poor sales caused by 2 national
0 estrictions on prescribing, doubts over long term safety and too high a cost
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.
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
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
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
Gemtuzumabozogamicin (Mylotar g)
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.
Drotrecoginalfa (Xigris) 2011
Withdrawn by Lily worldwide following results of the PROWESS-SHOCK study that showed lack of efficacy.
Examples of adverse effects associated with specific medications[edit]
Rhabdomyolysis statins (a class of lipid-lowering drugs)
Seizures withdrawal from benzodiazepines
Stroke or heart attack sildenafil when used with nitroglycerine; COX-2 inhibitors
Suicide, increased tendency antidepressants
Parkinsonism MPTP, a meperidine related drug considered highly neurotoxic
Tardive dyskinesia long-term use of metoclopramide, cinnarizine and many antipsychotic medications
Spontaneous Tendon rupture fluoroquinolone drugs [24] even occurring as late as 6 months after treatment had been terminated.[25]�
Weight loss some antidepressants, like fluoxetine and bupropion
Weight gain some antipsychotics (e.g. olanzapine and clozapine) and antidepressants (mirtazapine)
October 01, 2013 Hospira Recalls One Lot of Metoclopramide Injection, USP, and two lots of Ondansetron Injection, USP, Due to Glass (Glass Strands) Particulates
September 13, 2013 Hospira Recalls One Lot of 0.25% Bupivacaine HCL Injection, USP (2.5 MG/ML), 30 ML Single-Dose Vial and One Lot of 0.75% Bupivacaine HCL Injection, USP (7.5 MG/ML), 30 ML Single Dose Vial
September 10, 2013 Leiter's Compounding Pharmacy Recalls Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor
September 10, 2013 Park Compounding: Sterile Medication Recall – Concerns of Sterility
September 09, 2013 Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor
September 06, 2013 McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz.
September 06, 2013 University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns
September 06, 2013 Altaire Pharmaceuticals, Inc. Recalls 9 Lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution Sold Under Several Brands
September 04, 2013 Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing
August 29, 2013 Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Four Lots of Cubicin (Daptomycin for Injection) 500mg in 10ml Single Use Vials Due to Presence of Particulate Matter
August 27, 2013 JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor
August 26, 2013 Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor
August 23, 2013 Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance
August 17, 2013 Aidapak Services Llc Initiates Voluntary Recall of Selected Pharmaceuticals Repackaged by Aidapak Services Llc Due to Potential Incorrect Labeling Aidapak Shipped Affected Products to Four States Only: Washington, Oregon, California, and Arizona
August 09, 2013 Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events
August 01, 2013 Nexus Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of BenztropineMesylate Injection, USP 2 mg/2 mL (1 mg/mL), in 2 mL Single Dose Vials
July 31, 2013 Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance
July 03, 2013 Sandoz US Announces Voluntary Nationwide Recall of One Lot of Estarylla
June 30, 2013 Fresenius Kabi USA Issues Voluntary Nationwide Recall of BenztropineMesylate Injection, USP 2 mg/2 mL (1 mg/mL), in 2 mL Single Dose Vials
June 19, 2013 Advance Pharmaceutical Inc. Issues Voluntary Recall of One Lot of Enteric Coated Aspirin Tablets, 81 mg, Due to Health Risk
June 13, 2013 Sagent Pharmaceuticals Expands a Nationwide Voluntary Recall to All Lots of Vecuronium Bromide for Injection, 10mg Single Use Vials Manufactured by Mustafa Nevzat (MN Pharmaceuticals)
June 10, 2013 Zydus Pharmaceuticals USA Inc. Issues Voluntary Nationwide Recall of Warfarin 2 mg Tablets, Lot MM5767, Expiration Date June 2014, Due to Oversized Tablets
June 07, 2013 Sagent Pharmaceuticals Recalls Three Lots of Vecuronium Bromide for Injection, 10mg Manufactured by Mustafa Nevzat (MN Pharmaceuticals) Due to Elevated Impurity Levels
May 29, 2013 Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance
May 28, 2013 Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products
May 25, 2013 Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate
May 20, 2013 Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable Vials, 25mg/mL, 40mL vials
May 15, 2013 Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients
May 06, 2013 In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area
May 10, 2013 Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution
April 26, 2013 Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution
April 26, 2013 Hospira Issues a Voluntary Nationwide Recall of One Lot Of 0.9% Sodium Chloride Injection, Usp, 100 Ml, Flexible Containers Due to Particulate – Revised to Update Stericycle Phone Number
April 22, 2013 Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance
April 17, 2013 Balanced Solutions Compounding Pharmacy, LLC. Recalls All Sterile Compounded Products Due to a Lack of Sterility Assurance
April 15, 2013 ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns
April 15, 2013 NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns
April 05, 2013 Green Valley Drugs Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns
March 29, 2013 Hospira Recalls One Lot of 0.9% Sodium Chloride Injection Due to Brass Particulates
March 26, 2013 Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed
March 20, 2013 Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination
March 20, 2013 Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance
March 18, 2013 Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye Infection
March 17, 2013 Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination
March 16, 2013 Medprep Consulting Inc. Recalls All Lots Of Magnesium Sulfate 2gm In Dextrose 5 percent In Water, 50ml For Injecton Due To Mold Contamination
February 23, 2013 Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection
February 15, 2013 Reumofan Plus USA, LLC and Reumofan USA, LLC is Voluntarily Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients
February 15, 2013 Gilead Recalls One Lot of Vistide® (CIDOFOVIR INJECTION) Due To Presence Of Particulate Matter
January 17, 2013 Advance Pharmaceutical Recalls one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets
January 10, 2013 Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
'PLICTS OF INTEREST COllFLtCT!I OP 1N't £ST c.oMJ\.•''n OJ ....t '\' CAM,:\.t..""n 011 "'' "(\
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FDA employees ar·e tr·ained in SINthetic dr·ugs, and hope to get better· paying jobs, gr·ants, tr·ips, favor·s to relatives and fr·iends by Dr·ug companies. They are unable to see the damages of evidence based SINthetic dr·ugs
COUHTERiHINK
!I titne !JC>f\e
first ruMished. Yes the ·Dru!J CC>"'f'at'lies al'\d the fDA are sittif\!1 C>f\ the researth that C>f\fittns C>l'\d a shade>w c,f dC>ut that the S l'thetidru!JS
Mt safe af\d the dC> 11\C>te ham thai\ !JC>C>d. Sut sif\e rnedidl'e has e C>tne SC> deref\del't C>f\ these
dru!JS, the dtu!l C>tnf'ar.ies hne SC>C>C>C> tnuh 11\C>l'\e, we>uld e diffi ult tC> reteah all dC> tC>rs rnedidf\e,
the fDA af\d ·Dru!JS sit C>Y.' the researth , af\d dtu!l
aused iatre>!lef\idisease iHreases Drarnati aH
The origins of Synthetic Phannaceuticals came from doctors like Fleming and other doctors who thought that drug companies should not be built on Profit but on serving People at the lowest price possible. But these English ideas turned to Profit based ideas as the drug companies took hold in America. These ruthless corporations are
ruled by Profit and Profit alone. And Greed Rules over all.
This list is from 1999. The following drug products were withdrawn or removed from the market because such drug products or components of such drug products were found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate: All drug products containing adenosine phosphate.
Adrenal cortex: All drug products containing adrenal cortex. Azaribine: All drug products containing azaribine. Benoxaprofen: All drug products containing benoxaprofen. Bithionol: All drug products containing bithionol. Bromfenac sodium: All drug products containing bromfenac sodium. Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil. Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated casein. Chlorhexidinegluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation. Chlormadinone acetate: All drug products containing chlormadinone acetate.
Chloroform: All drug products containing chloroform. Cobalt: All drug products containing cobalt salts (except
radioactive forms of cobalt and its salts and cobalamin and its
derivatives). Dexfenfluramine hydrochloride: All drug products containing
dexfenfluramine hydrochloride. Diamthazoledihydrochloride: All drug products containing diamthazoledihydrochloride. Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose. Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate. Dipyrone: All drug products containing dipyrone. Encainide hydrochloride: All drug products containing encainide hydrochloride. Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan.
Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated
glycerol. Gonadotropin, chorionic: All drug products containing chorionic
gonadotropins of animal origin. Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate. Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride. Methapyrilene: All drug products containing methapyrilene. Methopholine: All drug products containing methopholine. Mibefradildihydrochloride: All drug products containing mibefradildihydrochloride.
Neomycin sulfate: All parenteral drug products containing neomycin sulfate. Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatalogic application). Nomifensine maleate: All drug products containing nomifensine maleate. Oxyphenisatin: All drug products containing oxyphenisatin. Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate. Phenacetin: All drug products containing phenacetin. Phenformin hydrochloride: All drug products containing phenformin hydrochloride. Pipamazine: All drug products containing pipamazine.
Potassium arsenite: All drug products containing potassium arsenite.
Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion). Povidone: All intravenous drug products containing povidone.
Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine. Sparteine sulfate: All drug products containing sparteine sulfate. Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole (except those formulated for vaginal use). Suprofen: All drug products containing suprofen (except ophthalmic solutions).
Sweet spirits of nitre: All drug products containing sweet spirits of nitre. Temafloxacin hydrochloride: All drug products containing temafloxacin hydrochloride. Terfenadine: All drug products containing terfenadine.
3,3',4',5-tetrachlorosalicylanilide: All drug products containing 3,3',4',5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter. Ticrynafen: All drug products containing ticrynafen. Tribromsalan: All drug products containing tribromsalan. Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
Urethane: All drug products containing urethane. Vinyl chloride: All aerosol drug products containing vinyl
chloride. Zirconium: All aerosol drug products containing zirconium.
Zomepirac sodium: All drug products containing zomepirac sodium.
Dated: October 1, 1998.
THE SPECIAL LAW FOR THE PHARMECEUTCAL COMPANIES
In the real world of commerce, if a company sells you something that hurts somebody you can sue them for damages. The Toyota cars killed people, and they had to pay damages. But the drug companies have a special exemption to this liability. To sue them for damages you must prove they knew it would hurt before they sold it and sold it anyway. Just being hurt is not enough to get damages. You must prove that they knowingly sold a drug that could hurt.
This allows them to hurt people and make massive profits and not be held responsible for damages. But still they are sued for damages in the multi billions of dollars each year when lawyers feel they have a case and can possibly prove the company knowingly sold a harmful substance.
If we change this law and hold them responsible for all damages then the world changes.