Prescription Drug Warnings

Prescription Drugs

Prescription Drug Warnings
Latest Medical Alerts

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

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

Prescription Drug Alerts
2008		Drug	Use	Company	. Side Effects/ Source
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
-	-	-	-	-	-
60	80	120	100	100	250-710

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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This Vaughns Prescription Drug Warnings Summary Chart web page was updated on 2008-01-17.