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FDA Orders New Warnings and Revised Prescribing Information for 35 Drugs

Apr 18, 2016

The Food and Drug Administration (FDA) issued a Drug Safety Labeling Changes announcement that lists label changes and revised prescribing information for 35 different products. The changes involve Contraindications, Warnings, Precautions, and Adverse Reactions sections of the labels.

The drugs include some widely prescribed medicines like the antipsychotic Risperdal, type 2 diabetes drugs Invokana and Invokamet, and the antiviral Truvada. The changes involved the Contraindications, Warnings, and Precautions sections of the product labels. Some of the drugs had label changes in more than one category and some drugs must now carry a Boxed Warning, which is the FDA’s most serious warning category. Consumers can find a chart of the affected drugs in the Drug Safety Labeling Changes announcement on the FDA web site. To see details of the warnings and get a link to the revised prescribing information, click on the drug’s name. The following drugs have changes:

  • Adcetris (brentuximab vedotin) for Injection
  • Angiomax (bivalirudin) Lyophilized Powder for Injection
  • Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules
  • Faslodex (fulvestrant) Solution for Injection
  • Furosemide Tablets, Injection and Lasix (furosemide) Tablets
  • Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir 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) Tablet
  • 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)

Individuals taking any of these medications should discuss any concerns about the medication with a doctor. Except in rare cases, the FDA advises patients not to change dosage or discontinue taking a prescribed medication without first consulting a health care provider about the risks and benefits of the drug.

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