The U.S. Food and Drug Administration (FDA) has ordered label changes and revised prescription information for 35 drugs in a March 2016 Drug Safety Labeling Changes announcement. The changes include Contraindications, Warnings, Precautions, and Adverse Reactions as part of the label.
The type 2 diabetes drugs Invokana and Invokamet, the antiviral Truvada, and the antipsychotic drug Risperdal (in oral solution, tablet, and injectable forms) are among the drugs listed. The aforementioned changes involve the Contraindications, Warnings, and Precautions part of the medication labels. For some of the drugs, the FDA made changes in several categories. Certain drugs must add a Boxed Warning, the FDA’s most significant warning. On the FDA website, consumers can find a chart of the affected drugs in the Drug Safety Labeling Changes announcement. The following are the drugs that have changes:
Adcetris (brentuximab vedotin) for injection
Angiomax (bivalirudin) Lyophilized Powder for Injection
Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules
Faslodex (fulvestrant) Solutution for Injection
Furosemide Tablets, Injection and Lasix (furosemide) Tablets
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovier alafenamide) Fixed-dose Combination Tablet
Herceptin (trastuzumab) Intravenous Infusion
Implanon (etonogestrel) Implant
Invega (paliperidone) Extended-Release Tablets
Invega Sustenna (paliperidone palmitate) Extended-release Injectable Suspension
Invega Trinza (paliperidone palmitate) Extended-release Injectable Suspension
Invokamet (canagliflozin and metformin hydrochloride) Tablets
Invokana (canagliflozin) Tablets
Jakafi (ruxolitinib phosphate) Tablets
Juxtapid (lomitapide) Capsules
Klonopin (clonazepam) Tablets
Nexplanon (etonogestrel) Implants
Oxytrol for women (oxybutynin) Transdermal System
PLASMA-LYTE 56 and 5% Dextrose Injection
Prezcobix (darunavir and cobicistat) Tablet
Renagel (sevelamer hydrochloride) Tablets
Renvela (sevelamer carbonate) Powder for Oral Suspension
Risperdal (risperidone) Tablets, Oral Solution and Risperdal M-TAB (risperidone) Orally Disintegrating Tablets
Risperdal Consta (risperidone) Long Acting Injection
Sustiva (efavirenz) Capsules and Tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Tudorza Pressair (aclidinium bromide inhalation powder)
Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand)
Zarxio (filgrastim-sndz)
Consumers taking any of these drugs should discuss concerns about the medication with a doctor.
