FDA Drug Label Warning Changes

Posted on October 9, 2015 by Angela A Stanton, Ph.D.

****************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 Angela A Stanton, Ph.D.

Angela A Stanton, PhD, is a Neuroeconomist focusing on chronic pain--migraine in particular--physiology, electrolyte homeostasis, nutrition, and genetics. She lives in Southern California. Her current research is focused on migraine cause, prevention, and treatment without the use of medicine. As a forever migraineur from childhood, 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 variations of all voltage dependent channels, gates, and pumps (chanelopathy) that modulate electrolyte mineral density and voltage in the brain. In addition, insulin and glucose transporters, and several other variants, such as MTHFR variants of B vitamin methylation process and many others are different in the case of a migraineur from the general population. Migraineurs are glucose sensitive (carbohydrate intolerant) and should avoid eating carbs as much as possible. She is working on her hypothesis that migraine is a metabolic disease. As a result of the success of the first edition of her book and her helping over 5000 migraineurs successfully prevent their migraines world wide, all ages and both genders, and all types of migraines, she published the 2nd (extended) edition of her migraine book "Fighting The Migraine Epidemic: Complete Guide: How To Treat & Prevent Migraines Without Medications". The 2nd edition is the “holy grail” of migraine cause, development, and prevention, incorporating all there is to know. It includes a long section for medical and research professionals. The book is full of academic citations (over 800) to authenticate the statements she makes to make it easy to follow up by those interested and to spark further research interest. It is a "Complete Guide", published on September 29, 2017. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in Economics with dissertation in neuroscience (culminating in Neuroeconomics) at Claremont Graduate University, fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers, certification in LCHF/ketogenic diet from NN (Nutrition Network), certification in physiology (UPEN via Coursea), Nutrition (Harvard Shool of Public Health) and functional medicine studies. Dr. Stanton is an avid sports fan, currently power weight lifting and kickboxing. For relaxation (yeah.. about a half minute each day), she paints and photographs and loves to spend time with her family of husband of 45 years, 2 sons and their wives, and 2 granddaughters. Follow her on Twitter at: @MigraineBook, LinkedIn at https://www.linkedin.com/in/angelaastantonphd/ and facebook at https://www.facebook.com/DrAngelaAStanton/
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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:
    October 11, 2015 at 4:47 am

    You left out Flouroquinolones
    Cipro
    Levequin
    Avelox

    Liked by 1 person

    Reply
    • cluelessdoctors says:
      October 11, 2015 at 11:27 am

      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

      Reply

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