New Warnings and Revised Prescribing Information for 35 Drugs

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.

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