42 Drug Safety Labeling Changes

FDA’s list of drugs that underwent label modifications in June.

MedWatch / Image: FDA
MedWatch / Image: FDA

On July 7th, MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, posted a list of 42 products with safety label changes in the month of June. The following drugs had changes applied 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)

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