Drug Projects
Americans are bombarded with ads that begin with “Talk to your doctor about…” and plug some pharmaceutical product or device. And many doctor-patient encounters end with a prescription of some sort. The rising cost of drugs and devices is a major contributor to overall health costs in this country; whether or not we are getting value for money is an open question.
Moreover, a number of high-profile drugs have come under intense scrutiny in the last several years and Public Citizen has played an important role in many: Vioxx, Avandia, Viagra, Rezulin.
Public Citizen has been assessing the quality and efficacy of drugs and devices since its founding in 1971. When we feel that the information provided to doctors or patients is misleading, insufficient, or just plain wrong, we do not hesitate to express an opinion. Worst Pills, Best Pills, our monthly print newsletter and our Web site, WorstPills.org, have been at the forefront of the provision of information to patients. We also use the law, petitions, and letters to monitor the FDA and coax the agency into action. Our actions have contributed to nine drugs being pulled off the market. Public Citizen has also been instrumental in getting “black box” and other warnings on drugs.
Actos
Generic Name: Pioglitazone
Life-Threatening Liver Toxicity of Avandia (Rosiglitazone) Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal, July 22, 2009
Petition Requesting Updated Labeling for Diabetes Drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Amitiza
Generic name: Lubiprostone
Petition Requesting Enhanced Warnings for Lubiprostone (Amitiza), May 6, 2009
Apri-28
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Arcoxia
Generic name: Etoricoxib
Letter Urging that Rimonabant (Zimulti) and Etoricoxib (Arcoxia) be Removed from the European Market, July 16, 2007
Testimony Concerning Etoricoxib (Arcoxia), April 12, 2007
AvandIa
Generic name: Rosiglitazone
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Life-Threatening Liver Toxicity of Rosiglitazone (Avandia) Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal, July 22, 2009
Petition to Ban Diabetes Drug Rosiglitazone (Avandia), October 30, 2008
Testimony on Rosiglitazone (Avandia), July 30, 2007
Letter Demonstrating that FDA Knew About Rosiglitazone (Avandia) Dangers, May 22, 2007
Statement: New Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Rosiglitazone (Avandia), May 21, 2007
Petition Requesting Updated Labeling for Diabetes drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Bextra
Generic Name: Valdecoxib
Statement: Valdecoxib (Bextra) Ban a Good Step, But FDA Should Pull Celecoxib (Celebrex) Too, April 7, 2005
Petition to Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) From the Market, January 24, 2005
Public Citizen v. FDA (Seeking records on a unapproved use of a drug), February 26, 2004
Blood Substitutes
Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death Meta-analysis Published in JAMA, April 28, 2008
Testimony Concerning Protocol for Biopure's Blood Sub HBOC-201, December 14, 2006
Sidney Wolfe v. FDA (Seeking to open up an FDA advisory committee meeting), July 12, 2006
BOTOX
Generic name: Botulinum Tonxin
Statement: FDA Grants Public Citizen's Petition on Botulinum Toxin (Botox, Myobloc), April 30, 2009
Statement: A Sad Day: Olympians Tout Botulinum Toxin (Botox, Myobloc), July 15, 2008
Statement: FDA's Botulinum Toxin (Botox, Myobloc) Warning Falls Short, February 8, 2008
Petition Requesting Regulatory Action Concerning the Spread of Botulinum Toxin (Botox, Myobloc) to Other Parts of the Body, January 23, 2008
Botulinum Toxin
Brand nameS: Botox and Myobloc
Statement: FDA Grants Public Citizen's Petition on Botulinum Toxin (Botox, Myobloc), April 30, 2009
Statement: A Sad Day: Olympians Tout Botulinum Toxin (Botox, Myobloc), July 15, 2008
Statement: FDA's Botulinum Toxin (Botox, Myobloc) Warning Falls Short, February 8, 2008
Petition Requesting Regulatory Action Concerning the Spread of Botulinum Toxin (Botox, Myobloc) to Other Parts of the Body, January 23, 2008
Celebrex
Generic name: Celecoxib
Letter Concerning Pfizer's Television Advertisement for Celebrex, April 9, 2007
Statement: Valdecoxib (Bextra) ban a good step, but FDA Should pull Celecoxib (Celebrex) too, April 7, 2005
Petition to Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market, January 24, 2005
Celecoxib
Brand name: Celebrex
Letter Concerning Pfizer's Television Advertisement for Celebrex, April 9, 2007
Statement: Valdecoxib (Bextra) ban a good step, but FDA Should pull Celecoxib (Celebrex) too, April 7, 2005
Petition to Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market, January 24, 2005
Cethromycin
Testimony on Cethromycin for the Treatment of Community-Acquired Bacterial Pneumonia
June 2, 2009
Cialis
Generic name: Tadalafil
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Cough and Cold Medications for Children
Testimony on Cough and Cold Remedies for Children, October 2, 2008
Testimony on the Availability of Over-the-Counter Pediatric Cough and Cold Formulations, October 19, 2007
Crestor
Generic name: Rosuvastin
Letter Urging Action on AstraZeneca's Misleading Crestor Advertising, November 24, 2004
CYCLESSA
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Darvon
Generic name: Propoxyphene
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Petition Asking FDA to Reconsider Banning Propoxyphene (Darvon), August 6, 2009
Statement: FDA Committee Vote Confirms Propoxyphene’s (Darvon's) Risks Outweigh Benefits, Drug Should Be Banned, January 30, 2009
Testimony on Propoxyphene (Darvon), January 30, 2009
Public Citizen v. FDA (Seeking order compelling FDA to respond to Public Citizen petition to ban Darvon), June 19, 2008
Petition to Ban all Propoxyphene (Darvon) Products, February 28, 2006
Desogen
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Desogestrel
Brand names: Desogen, Mircette, Velivet, Apri-28, Kariva, Ortho-Cept, Reclipsen and Cyclessa
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Dronedarone
Brand name: Multaq
Critique of New Antiarrhythmic Drug Dronedarone (Multaq) Published in the New England Journal of Medicine, June 4, 2009
Effient
Generic name: Prasugrel
Letter Urging FDA to Halt its Review of Prasugrel (Effient), June 3, 2009
Letter to FDA About Safety of Prasugrel (Effient) and Removal of Advisory Committee Member, February 19, 2009
Prasugrel (Effient) STEMI Subgroup Analysis Published in the Lancet, May 30, 2009
Ethinyl Estradiol/ Norelgestromin
Brand name: Ortho-Evra
Petition to Ban Ethinyl Estradiol/Norelgestromin (Ortho-Evra), May 8, 2008
Etoricoxib
Brand name: Arcoxia
Letter Urging that Rimonabant (Zimulti) and Etoricoxib (Arcoxia) be Removed from the European Market, July 16, 2007
Testimony Concerning Etoricoxib (Arcoxia), April 12, 2007
Exelon
Generic name: Rivastigmine
Testimony on Rivastigmine (Exelon), May 17, 2006
Gatifloxacin
Brand name: Tequin
Public Citizen v. FDA (Seeking order compelling FDA to repond to Public Citizen petition for enhanced warnings), January 3, 2008
Petition for a Black Box Warning on Fluoroquinolone Antibiotics, August 29, 2006
Petition to Ban the Antibiotic Gatifloxacin (Tequin), May 1, 2006
Petition to Require a Warning on All Fluoroquinolone Antibiotics, August 1, 1996
Growth Hormone
CNN Program on Use of Growth Hormone for Normal Small Children, June 20, 2006
Testimony Concerning the Use of Growth Hormone for Idiopathic Short Stature, June 10, 2003
Hepatitis B Vaccine
Sharkey v. FDA and Merck (Seeking detailed data on vaccine production numbers), July 8, 2005
Hepatitis E Vaccine
Letter in the New England Journal of Medicine About Ethical Concerns with Hepatitis E Vaccine Trial, June 7, 2007
Kariva
Brand name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Levitra
Generic name: Vardenafil
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Lovastatin
Brand name: Mevacor
Testimony on the Public Health Dangers of Making Lovastatin (Mevacor) Available Over-the-Counter, December 13, 2007
Testimony on Public Health Dangers of Prescription-to-OTC Switch of Lovastatin (Mevacor), January 14, 2005
Lubiprostone
Brand name: Amitiza
Petition Requesting Enhanced Warnings for Lubiprostone (Amitiza), May 6, 2009
Meridia
Generic name: Sibutramine
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Petition to Ban Sibutramine (Meridia), December 3, 2009
Supplement to Petition to Ban Sibutramine (Meridia), September 3, 2003
Petition to Ban the Diet Drug Sibutramine (Meridia), March 19, 2002
Mevacor
Generic name: Lovastatin
Testimony on the Public Health Dangers of Making Lovastatin (Mevacor) Available Over-the-Counter, December 13, 2007
Testimony on Public Health Dangers of Prescription-to-OTC Switch of Lovastatin (Mevacor), January 14, 2005
Milnacipran
Brand name: Savella
Petition to Ban Fibromyalgia Drug Milnacipran (Savella), January 20, 2010
Mircette
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Multaq
Generic name: Dronedarone
Critique of New Antiarrhythmic Drug Dronedarone (Multaq) Published in the New England Journal of Medicine, June 4, 2009
Myobloc
Generic name: Botulinum Toxin
Statement: FDA Grants Public Citizen's Petition on Botulinum Toxin (Botox, Myobloc), April 30, 2009
Statement: A Sad Day: Olympians Tout Botulinum Toxin (Botox, Myobloc), July 15, 2008
Statement: FDA's Botulinum Toxin (Botox, Myobloc) Warning Falls Short, February 8, 2008
Petition Requesting Regulatory Action Concerning the Spread of Botulinum Toxin (Botox, Myobloc) to Other Parts of the Body, January 23, 2008
Orlistat
Brand name: Xenical
Supplement to Petition to Ban Diet Drug Orlistat (Xenical), June 5, 2006
Petition to Remove the Diet Drug Orlistat (Xenical) From the Market, April 10, 2006
Testimony on Possible Switch of Orlistat (Xenical) to OTC Status, January 23, 2006
Ortho-cept
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Ortho-evra
Generic name: Ethinyl Estradiol/ Norelgestromin
Petition to Ban Ethinyl Estradiol/Norelgestromin (Ortho-Evra), May 8, 2008
OxycodonE
Brand name: Oxycontin
Congressional Testimony on OxyContin and the Prosecution of Purdue, July 31, 2007
Oxycontin
Generic Name: Oxycodone
Congressional Testimony on OxyContin and the Prosecution of Purdue, July 31, 2007
Paroxetine
Brand name: Paxil
Hoormann v. SmithKline Beecham Corporation (Challenging class action settlement), June 26, 2009
Paxil
Generic name: Paroxetine
Hoormann v. SmithKline Beecham Corporation (Challenging class action settlement), June 26, 2009
Phenergan
Generic name: Promethazine
Wyeth v. Levine (Do FDA labels preempt liability claims in state courts?), March 4, 2009
Pioglitazone
Brand name: Actos
Life-Threatening Liver Toxicity of Avandia (Rosiglitazone) Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal, July 22, 2009
Petition Requesting Updated Labeling for Diabetes Drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Prasugrel
Brand name: Effient
Letter Urging FDA to Halt its Review of Prasugrel (Effient), June 3, 2009
Letter to FDA About Safety of Prasugrel (Effient) and Removal of Advisory Committee Member, February 19, 2009
Prasugrel (Effient) STEMI Subgroup Analysis Published in the Lancet, May 30, 2009
Promethazine
Brand name: Phenergan
Wyeth v. Levine (Do FDA labels preempt liability claims in state courts?), March 4, 2009
Propoxyphene
Brand name: Darvon
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Petition Asking FDA to Reconsider Banning Propoxyphene (Darvon), August 6, 2009
Statement: FDA Committee Vote Confirms Propoxyphene’s (Darvon's) Risks Outweigh Benefits, Drug Should Be Banned, January 30, 2009
Testimony on Propoxyphene (Darvon), January 30, 2009
Public Citizen v. FDA (Seeking order compelling FDA to respond to Public Citizen petition to ban Darvon), June 19, 2008
Petition to Ban all Propoxyphene (Darvon) Products, February 28, 2006
Quetiapine Fumarate
Brand name: Seroquel
Letter urging FDA to Reject Use of Quetiapine Fumarate (Seroquel) in Depression, April 9, 2009
Reclipsen
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Rezulin
Generic name: Troglitazone
Petition Requesting Updated Labeling for Diabetes drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Testimony Advising the FDA to Withdraw Troglitazone (Rezulin), March 26, 1999
Rimonabant
Brand name: Zimulti
Letter Urging that Rimonabant (Zimulti) and Etoricoxib (Arcoxia) be Removed from the European Market, July 16, 2007
Testimony on Rimonabant (Zimulti), June 13, 2007
Rivastigmine
Brand Name: Exelon
Testimony on Rivastigmine (Exelon), May 17, 2006
Rosiglitazone
Brand name: Avandia
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Life-Threatening Liver Toxicity of Rosiglitazone (Avandia) Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal, July 22, 2009
Petition to Ban Diabetes Drug Rosiglitazone (Avandia), October 30, 2008
Testimony on Rosiglitazone (Avandia), July 30, 2007
Letter Demonstrating that FDA Knew About Rosiglitazone (Avandia) Dangers, May 22, 2007
Statement: New Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Rosiglitazone (Avandia), May 21, 2007
Petition Requesting Updated Labeling for Diabetes drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Rosuvastin
Brand name: Crestor
Letter Urging Action on AstraZeneca's Misleading Crestor Advertising, November 24, 2004
Savella
Brand name: Milnacipran
Petition to Ban Fibromyalgia Drug Milnacipran (Savella), January 20, 2010
Serdolect
Generic name: Sertindole
Letter Urging Rejection of Antipsychotic drug Sertindole (Serdolect) Due to Risk of Sudden Cardiac Death, April 9, 2009
Seroquel
Generic name: Quetiapine Fumarate
Letter urging FDA to Reject Use of Quetiapine Fumarate (Seroquel) in Depression, April 9, 2009
Sertindole
Brand name: Serdolect
Letter Urging Rejection of Antipsychotic drug Sertindole (Serdolect) Due to Risk of Sudden Cardiac Death, April 9, 2009
Sibutramine
Brand name: Meridia
Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
Petition to Ban Sibutramine (Meridia), December 3, 2009
Supplement to Petition to Ban Sibutramine (Meridia), September 3, 2003
Petition to Ban the Diet Drug Sibutramine (Meridia), March 19, 2002
Sildenafil
Brand name: Viagra
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Letter Urging the Therapeutic Products Program in Canada to Require Warnings on the Label of Sildenafil (Viagra), August 24, 1998
Letter Urging FDA to Convene an Advisory Committee to Review Problems Related to the Use of Sildenafil (Viagra) , August 20, 1998
Petition to Add Information about Sildenafil's (Viagra's) Dangers to the Drug's Label, July 1, 1998
Surfactant
Brand name: Surfaxin
Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America, February 17, 2007
Press Release: Placebo-Controlled Drug Trial in Latin America Redesigned, April 4, 2001
Letter Requesting that HHS Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome, February 22, 2001
Letter Concerning Unethical Studies Which Used Placebos on HIV-Positive Pregnany Women in Developing Countries, October 23, 1997
Letter Concerning Funding of Unethical Trials Which Administer Placebos to HIV-infected Pregnant Women, April 22, 1997
Surfaxin
Generic name: Surfactant
Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America, February 17, 2007
Press Release: Placebo-Controlled Drug Trial in Latin America Redesigned, April 4, 2001
Letter Requesting that HHS Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome, February 22, 2001
Letter Concerning Unethical Studies Which Used Placebos on HIV-Positive Pregnany Women in Developing Countries, October 23, 1997
Letter Concerning Funding of Unethical Trials Which Administer Placebos to HIV-infected Pregnant Women, April 22, 1997
Tadalafil
Brand name: Cialis
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Tequin
Generic name: gatifloxacin
Public Citizen v. FDA (Seeking order compelling FDA to repond to Public Citizen petition for enhanced warnings), January 3, 2008
Petition for a Black Box Warning on Fluoroquinolone Antibiotics, August 29, 2006
Petition to Ban the Antibiotic Gatifloxacin (Tequin), May 1, 2006
Petition to Require a Warning on All Fluoroquinolone Antibiotics, August 1, 1996
Topamax
Generic name: Topiramate
Letter Criticizing a Campaign Promoting the Unapproved Use of Topiramate (Topamax) for Treating Alcoholics, October 9, 2007
Topiramate
Brand name: Topamax
Letter Criticizing a Campaign Promoting the Unapproved Use of Topiramate (Topamax) for Treating Alcoholics, October 9, 2007
Troglitazone
Brand name: Rezulin
Petition Requesting Updated Labeling for Diabetes drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000
Testimony Advising the FDA to Withdraw Troglitazone (Rezulin), March 26, 1999
Valacyclovir
Brand name: Valtrex
Letter in Obstetrics & Gynecology: Trials of Prophylaxis to Prevent Recurrent Herpes Should Not Utilize a Placebo Arm, December 1, 2006
Valdecoxib
Generic name: Bextra
Statement: Valdecoxib (Bextra) Ban a Good Step, But FDA Should Pull Celecoxib (Celebrex) Too, April 7, 2005
Petition to Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) From the Market, January 24, 2005
Public Citizen v. FDA (Seeking records on a unapproved use of a drug), February 26, 2004
Valtrex
Generic name: Valacyclovir
Letter in Obstetrics & Gynecology: Trials of Prophylaxis to Prevent Recurrent Herpes Should Not Utilize a Placebo Arm, December 1, 2006
Vardenafil
Brand name: Levtira
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Velivet
Generic name: Desogestrel
Petition to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Blood Clots, February 6, 2007
Viagra
Generic name: Sildenafil
Petition to Require a Black Box Warning for Erectile Dysfunction Drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra) to Warn of the Potential for Irreversible Vision Loss, October 20, 2005
Letter Urging the Therapeutic Products Program in Canada to Require Warnings on the Label of Sildenafil (Viagra), August 24, 1998
Letter Urging FDA to Convene an Advisory Committee to Review Problems Related to the Use of Sildenafil (Viagra) , August 20, 1998
Petition to Add Information about Sildenafil's (Viagra's) Dangers to the Drug's Label, July 1, 1998
Xenical
Generic name: Orlistat
Supplement to Petition to Ban Diet Drug Orlistat (Xenical), June 5, 2006
Petition to Remove the Diet Drug Orlistat (Xenical) From the Market, April 10, 2006
Testimony on Possible Switch of Orlistat (Xenical) to OTC Status, January 23, 2006
Zimulti
Generic name: Rimonabant
Letter Urging that Rimonabant (Zimulti) and Etoricoxib (Arcoxia) be Removed from the European Market, July 16, 2007
Testimony on Rimonabant (Zimulti), June 13, 2007