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U.S. Department of Health and Human Services

Safety

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Valium (diazepam) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS

  • Initial Section
  • Pregnancy
  • Labor and Delivery (new subsection)
  • Nursing Mothers (new subsection)

PRECAUTIONS

  • General
  • Information for Patients
  • Drug Interactions
    • Centrally Acting Agents
    • Alcohol
    • Antacids
    • Compounds Which Inhibit Certain Hepatic Enzymes
    • Phenytoin
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy: Category D
  • Geriatric Use (new subsection)
  • Hepatic Insufficiency (new subsection)

ADVERSE REACTIONS

  • Initial Section
  • Central Nervous System
  • Gastrointestinal System
  • Special Senses
  • Cardiovascular System
  • Psychiatric and Paradoxical Reactions
  • Urogenital System
  • Skin and Appendages
  • Laboratories
  • Other
  • Antegrade Amnesia...
  • Minor changes in EEG patterns...

Major revisions to labeling. See highlighted labeling for revised/new text.

CONTRAINDICATIONS

...Valium is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome...

WARNINGS

Initial Section

...As with other agents that have anticonvulsant activity, when Valium is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of Valium in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

Pregnancy

See section for new text.

Labor and Delivery
Special care must be taken when Valium is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

Nursing Mothers
Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving Valium.