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Medicine Summaries
Prescription Drugs

Prescription Drug Warnings
Medical Alerts from the FDA

Here is a news summary of selected prescription drug warnings and alerts, issued by the FDA, and other advisories.

Not all warnings have been included. I selected what I thought were some of the most important warnings, concerning the most common prescription drugs. The list is in reverse-chronological order - the most recent warnings are at the top.
Big Pharma Crime Spree

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60

30

80

80

30

Prescription Drug Alerts
2009

Drug

Use

Company

.
Side Effects*/
Source

2009

Nov. 2

Byetta (exenatide)

Type 2 diabetes

Amylin Pharm.

Kidney failure
FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems
#188708

2009

Aug. 24

orlistat
Xenical
Alli

Weight loss

Roche

Serious liver injury
FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat - Review includes both prescription drug Xenical and OTC drug Alli
#180057

2009

Aug. 4

Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab)

Cancer
TNF blockers

Several

Worse cancer, Death
FDA: Cancer Warnings Required for TNF Blockers
#175803

2009

Jul. 7

Darvon and Darvocet

Pain

Eli Lilly

Death
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
#170769

2009

Jul. 1

Chantix (varenicline)
and
Zyban (bupropion)

Stop smoking

Pfizer

GlaxoSmithKline

Suicide
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
#170100

2009

Jun. 16

Zicam

Cold remedy

Matrixx Initiatives

Loss of sense of smell
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies - Intranasal Zinc Product Linked to Loss of Sense of Smell
#167065

2009

Jun. 3

propylthiouracil

Anti-thyroid
Grave's disease

(generic)

Serious Liver Injury
FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug
#164207

2009

Apr. 8

Raptiva (efalizumab)

Psoriasis

Genentech

Death
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
#149561

2009

Feb. 19

Raptiva (efalizumab)

Psoriasis

Genentech

Death
FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
#149528

NOTICE

In its continuing efforts to obfuscate ITS OWN REPORTS on the ill effects of medications, the FDA has decided to BREAK all the links I (they) have provided below, to make it harder for you to find out the truth. Rather than simply REDIRECTING the old links to the new links, the FDA now refers you to A LIST of negative reports, thereby FORCING you to search ALL OVER AGAIN for the old report. BRILLIANT! More of the same, from the former drug company executives, who staff the FDA.

2008

Drug

Use

Company

.
Side Effects*/
Source

2008

Dec. 16

Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (Klonopin)
Clorazepate (Tranxene)
Divalproex sodium (Depakote, Depakote ER)
Ethosuximide (Zarontin)
Ethotoin (Peganone)
Felbamate (Felbatol)
Gabapentin (Neurontin)
Lamotrigine (Lamictal)
Lacosamide (Vimpat)
Levetiracetam (Keppra)
Mephenytoin (Mesantoin)
Methosuximide (Celontin)

Oxcarbazepine (Trileptal)
Phenytoin (Dilantin)
Pregabalin (Lyrica)
Primidone (Mysoline)
Rufinamide (Banzel)
Tiagabine (Gabitril)
Topiramate (Topamax)
Trimethadione (Tridione)
Valproic Acid (Depakene, Stavzor Extended Release Tablets)
Zonisamide (Zonegran)

epilepsy

various

Suicide
FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
#116991

2008

Sept. 4

Humira, Cimzia, Enbrel, and Remicade

rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease

various

Death
FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
#116942

2008

June 6

Regranex Gel 0.01% (becaplermin)

Diabetic sores

Ethicon

Death
Foot Cream Causes Cancer deaths
#1845

2008

Feb. 11

Heparin

Blood thinning

Baxter

Death
Difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure
Heparin Linked to Severe Allergic Reactions
#1797

2008

Jan. 16

Many cold preparations
(non-prescription)
pseudoephedrine, phenylephrine and ephedrine
diphenhydramine, brompheniramine and chlorpheniramine

Colds, coughs
Tylenol
Triaminic
Robitussin

Many
Johnson & J.
Novartis
Wyeth

Death - Children under 6

FDA Says NO COLD Medicines For Children Under 2

2008

Jan. 15

Vitorin (Zocor + Zetia)

Cholesterol

Merck
Schering-Plough

INCREASES PLAQUE

Merck Commits FRAUD

2007

Drug

Use

Company

.
Side Effects/
Source

2007

Dec. 21

Duragesic
(fentanyl skin patch

Pain

Johnson and Johnson

Death

FDA Issues Second Safety Warning on Fentanyl Skin Patch
#1762

2007

Dec. 3

ALL
"Can no longer protect us"
"The wheels have come off"
35,000 inspections 1970's
  6,000 inspections in 2007
Understaffing - minus 14%
Computers obsolete
No PCs for employees
"Congress At Fault" - cuts

FDA
ALL areas affected -
Foods recalled
Contaminated beef
Chinese imports
New Harmful Drugs
Older Harmful Drugs

FDA Broken - Endangers American Lives
ABC News

Life Endangerment
Source:

"FDA Science and Mission at Risk"

2007

Dec. 4

Avastin (bevacizumab)

Breast Cancer

Genentech

Death
Cardiovascular problems
Bowel perforation, infection
F.D.A. Criticizes Avastin Use for Breast Cancer
New York Times

2007

Nov. 20

Chantix (varenicline)

Smoking

Pfizer

Suicide
FDA Issues Early Communication for Chantix
#1749

2007

Nov. 14

Avandia (rosiglitazone)

Diabetes

GlaxoSmithKline

Heart Attack
FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia
#1743

2007

Nov. 8

Epogen, Pricrit, Aranest
(ESAs)
Erythropoiesis-Stimulating Agents

Anemia

Amgen
Ortho Biotech

Cancer Patients -
- Tumor Growth
Kidney Patients -
- Death, Stroke, Heart Attack

Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)
#1740

2007

Nov. 5

Trasylol (aprotinin)
(antifibrinolytic drug)

Bleeding Control

Bayer

Death

FDA Requests Marketing Suspension of Trasylol
#1738

2007

Oct. 26

Trasylol (aprotinin)
(antifibrinolytic drug)

Bleeding Control

Bayer

Death

FDA Issues Early Communication About an Ongoing Safety Review of Aprotinin Injection
#1733

2007

Oct. 18

Cialis (tadalafil)
Levitra (vardenafil HCl)
Viagra (sildenafil citrate)

Erectile Dysfunction

Lilly
Bayer - GSK
Pfizer

Sudden Hearing Loss

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
#1730

2007

Sept. 26

Fentora (fentanyl buccal) tablets

Cancer Pain

Cephalon

Death

FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug
#1711

2007

Sept. 17

Concerta (methylphenidate)
Strattera (atomoxetine)
Adderall (amphetamine)

ADHD

Pfizer,
GlaxoSmithKline
Lilly

Heart attack,
Stroke and Sudden Death

Possible Heart Risks With ADHD Medications
#1700

2007

Aug. 16

Coumadin (warfarin)

Anticoagulant

Bristol-Myers Squibb

Bleeding (too large a dose)
Blood Clots (to small a dose)

FDA Approves Updated Warfarin (Coumadin) Prescribing Information
#1684

2007

Aug. 14

Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride)

Diabetes

GlaxoSmithKline and Takeda

Heart Failure

FDA Strengthen Heart Failure Warning
#1683

2007

May 21

Avandia (rosiglitazone)

Diabetes

GlaxoSmith Kline

Heart Attack

FDA Issues Safety Alert on Avandia
1636

2007

May 2

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)

Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

Depression

Many

Suicide

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
#1624

2007

Mar. 30

neuroleptics: olanzapine and risperidone

Sedation

Eli Lilly
Janssen

Drugs are killing Alzheimer's patients
"unlicensed use of neuroleptics"
Alzheimer's sufferers dying in drug 'scandal'
A 3-year-old warning has gone unheeded, resulting in many premature deaths.

2007

Mar. 30

Zelnorm

IBS - Constipation

Novartis

Angina, heart attacks, and strokes

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons
#1597

2007

Mar. 29

Permax, Par, Teva

Parkinson's

Eli Lilly

Valvular heart disease

FDA Announces Voluntary Withdrawal of Pergolide Products
#1596

2007

Mar. 14

Ambien, Butisol, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconol, Sonata

Sleeping aids

Abbott
Lilly
Park Davis
Pharmacia
Questcor
Sanofi Aventis
Sepracor
Takeda
Tyco

Sleep driving


FDA Requests Label Change for All Sleep Disorder Drug Products
#1587

2007

Mar. 9

Aranesp
Epogen
Procrit

ESAs
anemia drugs

Amgen
Ortho Biotech

Death, blood clots, strokes

FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs)
#1582

2007

Feb. 26

NSAIDs, aspirin

Heart

many

Aspirin can raise blood pressure

Archives of Internal Medicine

2007

Feb. 21

Adderall
Adderall XR
Concert
Daytrana
Desoxyn
Dexedrine
Focalin
Focalin XR
Metadate CD
Methylin
Methylin
Ritalin
Ritalin SR
Ritalin LA
Strattera

ADHD

many

Physical - death, stroke, heart attack
Mental - hearing voices, paranoia, mania



FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events
#1568

2007

Feb. 21

Xolair

asthma

Genentech

Anaphylaxis - may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat

FDA Proposes to Strengthen Label Warning for Xolair
#1567

2006

Drug

Use

Company

.
Side Effects/
Source

2006

Dec. 19

OTC IAAA drug. commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen

pain, fever, headache

Various

Stomach bleeding, liver toxicity

FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
#1533

2006

Dec. 18

Rituxin

non-Hodgkin's lymphoma
lupus

Genentech

(PML), a fatal viral infection of the central nervous system

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population
#1532

2006

Nov. 9

Store brand Acetaminophen

pain reliever

Perrigo

Metal fragments in the caplets

FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets
#1507

2006

Feb. 16

Tequin

antibiotic

Bristol-Myers

Hypoglycemia and hyperglycemia

Stronger Warnings for Tequin
#1318

2006

Feb. 8

Trasylol

blood loss injection

Bayer

Heart attack, stroke

FDA Issues Public Health Advisory for Trasylol
#1311

2006

Jan. 19

Elidel, Protopic

eczema
atopic dermatitis

Novattis
Astellas Pharma

Cancer

FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic
#1299

2005

Drug

Use

Company

.
Side Effects/
Source

2005

Dec. 8

Paxil

depression

GlaxoSmith Kline

Birth defects

FDA Advising of Risk of Birth Defects with Paxil
#1270

2005

Sept. 29

Strattera

ADHD

Eli Lilly

Suicide, suicidal thinking

FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder
#1237

2005

Aug. 12

Accutane

acne

Hoffman LaRoche

Birth defects

FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne
#1218

2005

Jul. 19

Mifepristone
aka RU-486

abortion

Danco Labs

Fatal infection

FDA Issues Public Health Advisory for Mifepristone
#1207

2005

Jul. 15

Fentanyl patch

pain

Janssen Pharmaceuticals

Death

FDA Issues Public Health Advisory on the Fentanyl Patch
#1206

2004

Drug

Use

Company

.
Side Effects/
Source

2004

Oct. 28

Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa Wellbutrin, Luvox and Serzone

antidepressants, SSRIs

various

Suicide, thoughts of suicide

Labeling Change Request Letter for Antidepressant Medications

-

-

-

-

-

* Most drug descriptions de-emphasize the worst side effects. This webpage rather, emphasizes the worst side effects.

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Pres. Drug Warnings

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Rejected Pres. Drugs

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DISCLAIMER
The author is not a doctor.
NO MEDICAL ADVICE IS OFFERED OR IMPLIED.
Statements on this page may NOT be correct.
These are just my personal observations and opinions.
The sole purpose of this page is to encourage further research on your part.

I hope that you have found this drug news information page helpful.
Thank you very much for your time.

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Vaughn Aubuchon
Vaughn's Summaries
©2006-2009 Vaughn Aubuchon
www.vaughns-1-pagers.com
All Rights Reserved
This Vaughns Prescription Drug Warnings Summary Chart
was last updated on 2014-07-18.