FDA Drug Label Warning Changes

****************IMPORTANT*****************

The MedWatch September 2015 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

The “Summary Page” table provides a listing of product names and safety labeling sections revised:

The following drugs had modifications to the

BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS:

Accupril (quinapril hydrochloride) Tablets
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets
Altace (ramipril) Capsules
Avastin (bevacizumab)
Brilinta (ticagrelor) Tablets
Bydureon (exenatide extended-release) for Injectable Suspension
Cialis (tadalafil) Tablets
Clozaril (clozapine) Tablets
Combivir (lamivudine and zidovudine) Tablets
Doryx (doxycycline hyclate) Delayed-Release Capsules
Epzicom (abacavir and lamivudine) Tablets
Fazaclo (clozapine) Orally Disintegrating Tablets
Gazyva (obinutuzumab)
Humira (adalimumab) Solution
Invokamet (canagliflozin and metformin HCl) Tablets
Invokana (canagliflozin) Tablets
Levitra (vardenafil hydrochloride) Tablets
Myalept (metreleptin) for Injection
Neulasta (pegfilgrastim) Prefilled Syringe/On-body Injector
Neurontin (gabapentin) Capsules, Tablets, and Syrup
Nicorette (nicotine polacrilex) Gum
Nicorette (nicotine polacrilex) Large Lozenge
PegIntron (peginterferon alfa-2b) Injection, for Subcutaneous Use
Proglycem (diazoxide) Capsules and Oral Suspension
Sabril (vigabatrin) Tablet and Powder for Oral Solution
Sancuso (granisetron)
Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets
Stendra (avanafil) Tablets
Triumeq (abacavir sulfate, dolutegravir, and lamivudine) Tablets
Trizivir (abacavir, lamivudine, and zidovudine) Tablets
Velcade (bortezomib) for Injection
Versacloz (clozapine) Oral Suspension
Viagra (sildenafil citrate) Tablets
Votrient (pazopanib) Tablets
Xalkori (crizotinib)
Zestril (lisinopril) Tablets
Ziagen (abacavir) Tablets and Oral Solution

From now on I will keep all medicine box label updates posted here as well as on my public profile Facebook page for your guidance!

Because some medicines were not listed in the above update for some reason, I decided to paste here the entire list as it appears on the FDA site. Links are included with each medicine; please click and follow!

September 2015

September 2015

Drug Safety Labeling Changes
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME SECTIONS MODIFIED
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Brilinta (ticagrelor) Tablets X X
Clozaril (clozapine) Tablets X X X X X
Combivir (lamivudine and zidovudine) Tablets X X X X PCI
Epzicom (abacavir and lamivudine) Tablets X X X X
Fazaclo (clozapine) Orally Disintegrating Tablets X X X
Triumeq (abacavir sulfate, dolutegravir, and lamivudine) Tablets X X X X
Trizivir (abacavir, lamivudine, and zidovudine) Tablets X X X X X PCI, MG
Versacloz (clozapine) Oral Suspension X X X X
Ziagen (abacavir) Tablets and Oral Solution X X X X X PCI
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Cialis (tadalafil) Tablets

*PDE5 Inhibitors – Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

X PCI
Levitra (vardenafil hydrochloride) Tablets

*PDE5 Inhibitors – Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

X PCI
Myalept (metreleptin) for Injection X X X
Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets

*PDE5 Inhibitors – Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

X PCI
Stendra (avanafil) Tablets

*PDE5 Inhibitors – Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

X PCI
Viagra (sildenafil citrate) Tablets

*PDE5 Inhibitors – Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

X PCI
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Altace (ramipril) Capsules  X X
Bydureon (exenatide extended-release) for Injectable Suspension X X
Doryx (doxycycline hyclate) Delayed-Release Capsules X X X
Gazyva (obinutuzumab) X X
Humira (adalimumab) Solution X X
Invokamet (canagliflozin and metformin HCl) Tablets X X X
Invokana (canagliflozin) Tablets X X X
Neulasta (pegfilgrastim) Prefilled Syringe/On-body Injector X X
Neurontin (gabapentin) Capsules, Tablets, and Syrup X X X PCI
Proglycem (diazoxide) Capsules and Oral Suspension X X
Sabril (vigabatrin) Tablet and Powder for Oral Solution X X
Sancuso (granisetron) X X
Votrient (pazopanib) Tablets X X X PCI
Xalkori (crizotinib) X X X
Zestril (lisinopril) Tablets X X
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Accupril (quinapril hydrochloride) Tablets X
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets X
Avastin (bevacizumab) X X
Nicorette (nicotine polacrilex) Gum
Nicorette (nicotine polacrilex) Large Lozenge
X
PegIntron (peginterferon alfa-2b) Injection, for Subcutaneous Use  X
Velcade (bortezomib) for Injection X
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Breo Ellipta (fluticasone furoate/vilanterol) Inhalation Powder X
Cubicin (daptomycin for injection) X
Depakene (valproic acid) Capsules
Depakene (valproic acid) Oral Solution
Depakote (divalproex sodium) Delayed Release Tablets
Depakote Sprinkle Capsules (divalproex sodium delayed release capsules)
Depacon (valproate sodium) Injection
Depakote ER (divalproex sodium) Extended Release Tablets
X
Eliquis (apixaban) Tablets X
Estring (estradiol vaginal ring) X
Intermezzo (zolpidem tartrate) Sublingual Tablets X
Lastacaft (alcaftadine ophthalmic solution) X
Pradaxa (dabigatran etexilate mesylate) Capsules X
Savaysa (edoxaban tosylate) Tablets X
Temodar (temozolomide) Injection for Intravenous Use X
Xarelto (rivaroxaban) Tablets X
Zioptan (tafluprost ophthalmic solution) X

Questions are always appreciated! Please share so others can benefit from this update!

Angela

About Be Healthy

Angela A Stanton, PhD, is a Neuroeconomist who evaluates changes in behavior, chronic pain, decision-making, as a result of hormonal variations in the brain. She lives in Southern California. Her current research is focused on migraine cause, prevention and treatment without the use of medicines. As a migraineur, her discovery was helped by experimenting on herself. She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic mutations of insulin and glucose transporters, and voltage gated sodium and calcium channel mutations. Such mutations cause major shifts in a migraine brain, unlike that of a non-migraine brain. A non-migraineur can handle electrolyte changes on autopilot. A migraineur must always be on manual guard for such changes to maintain electrolyte homeostasis. The book Fighting The Migraine Epidemic: How To Treat and Prevent Migraines Without Medicines - An Insider's View explains why we have migraines, how to prevent them and how to stay migraine (and medicine) free for life. As a result of the success of the first edition of her book and new research and findings, she is now finishing the 2nd edition. The 2nd edition is the “holy grail” of migraines, incorporating all there is to know at the moment and also some hypotheses. It includes an academic research section with suggestions for further research. The book is full of citations to authenticate the statements she makes to be followed up by those interested and to spark further research interest. While working on the 2nd edition of the book she also published academic articles: "Migraine Cause and Treatment" Mental Health in family Medicine, November 23, 2015, open access "Functional Prodrome in Migraines" Journal of Neurological Disorders, January 22, 2016, open access "Are Statistics Misleading Sodium Reduction Benefits?", Journal of Medical Diagnostic Method, February 3, 2016, open access “A Comment on Severe Headache or Migraine History Is Inversely Correlated With Dietary Sodium Intake: NHANES 1999-2004” Angela A Stanton PhD, 19 July 2016 DOI: 10.1111/head.12861 not open access, subscription is required to read it. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in NeuroEconomics at Claremont Graduate University, and fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers. For relaxation Dr. Stanton paints and photographs. Follow her on Twitter at: @MigraineBook
This entry was posted in Big Pharma, Drugs of Shame, FDA, Must Read and tagged , , , , , , , , , . Bookmark the permalink.

4 Responses to FDA Drug Label Warning Changes

  1. Pingback: Triptans ± SSRIs ± Migraines ± Depression: Flip a Coin!- Hormones Matter

  2. Pingback: Triptans ± SSRIs ± Migraines ± Depression: Flip a Coin! - Hormones Matter

  3. Deniese berry says:

    You left out Flouroquinolones
    Cipro
    Levequin
    Avelox

    Liked by 1 person

    • Dear Deniese,

      There are no updates to Cipro, Levaquin, or Avelox at the FDA. The latest thing they have up there is the citizen petition I have written about and gave instructions how to add comments (there are 16 comments plus an open comment from a floxed pharmacist as of now) but as you can see in the letter I was sent by the FDA, there are no changes in the status of these drugs. There is a class action lawsuit but that is not an FDA update. This blog post is just an FDA update as I receive them every day via email.

      Hope this helps,

      Angela

      Like

I would love to see your thoughts!

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s