ATTENTION: FDA/Medwatch June Update: 42 Safety Labels Changes

The FDA/Medwatch released the June Update including  42 products with safety labeling changes. The update including, Warnings, Contradictions, Warning Labels, Precautions and Adverse Reactions on medicine many take everyday. It grabbed my attention, there are several drugs I take on the list. The FDA isn’t technically responsible for over the counter products, if it can cause a health risk to the public, the product is typically recalled. You can contact for more information.  Xx  M

FDA MedWatchJune 2016 Safety Labeling Changes includes 42products with revisions to Prescribing Information

The MedWatch June 2016 Safety Labeling Changes posting includes 42 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/or PRECAUTIONS sections:

Elitek (rasburicase)
Afinitor (everolimus)
Aubagio (teriflunomide)
Avycaz (ceftazidime and avibactam)
Bendeka (bendamustine hydrochloride)
Cardura (doxazosin)
Cerebyx (fosphenytoin sodium)
Children’s Motrin (ibuprofen)
Dilantin (phenytoin) Injection, Dilantin (phenytoin) Oral Suspension
Envarsus XR (tacrolimus extended release)
Farxiga (dapagliflozin)
Farydak (panobinostat)
Hectorol (doxercalciferol)
Humira (adalimumab)
Iclusig (ponatinib hydrochloride)
Kuvan (sapropterin dihydrochloride)
Lybrel (levonorgestrel and ethinyl estradiol)
Natpara (parathyroid hormone)
Nitromist (nitroglycerin)
Orfadin (nitisinone)
Pomalyst (pomalidomide)
Prezista (darunavir) Tablet and Oral Suspension
Sabril (vigabatrin) Oral Solution
Sabril (vigabatrin) Tablet
Stivarga (regorafenib)
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension
Technivie (ombitasvir, paritaprevir and ritonavir) Tablets
Tivicay (dolutegravir)
Tybost (cobicistat)
Tyvaso (treprostinil)
Viekira PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets)
Xigduo XR (dapagliflozin and metformin HCl extended-release)
Zosyn (piperacillin and tazobactam for injection) and Zosyn (piperacillin sodium and tazobactam sodium injection)

Categories: Moving Forward

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