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Special Alerts about benzodiazepines use

The FDA (Food and Drug Administration) announces that it is requiring an update to benzodiazepine products’ Boxed Warning to include the risks of misuse, addiction, abuse, withdrawal reactions, and physical dependence to improve their safe use. The FDA is also requiring other changes to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections of the prescribing information for all benzodiazepine products. 

Risks from concomitant use with opioids:

Concomitant use of benzodiazepines and opioids may result in respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing only if no alternatives are available. Limit dosages and durations to the minimum required. Follow up on the signs and symptoms of respiratory depression and sedation.

Abuse, misuse, and addiction:

The use of benzodiazepines, including Valium, exposes users to risks of misuse, abuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Valium and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

Dependence and withdrawal reactions:

The continued use of benzodiazepines, including Valium, for several days to weeks can result in significant physical dependence. sudden discontinuation or rapid dosage reduction of Valium after continued use may cause acute withdrawal reactions, which can be life-threatening. To reduce this risk, use a gradual taper to discontinue Valium or reduce the dosage.

Adverse Reactions

Incidence higher than 10%: Nervous system: Drowsiness (23%)

Incidence from 1% to 10%:

  • Cardiovascular: Hypotension (1% to 2%), vasodilation (1% to 2%)
  • Dermatologic: Skin rash (3%)
  • Gastrointestinal: diarrhea (4%) ,abdominal pain (≥1%), dysgeusia (2%)
  • Nervous system: emotional lability (≥1%), agitation (≥1%), headache (5%), confusion (≥1%), dizziness (3%), abnormality in thinking (1% to 2%) , euphoria (3%),  nervousness (≥1%), speech disturbance (≥1%), pain (≥1%).
  • Neuromuscular & skeletal:  lack of energy and strength (1% to 2%)
  • Respiratory: Asthma (2%), bleeding per nose (3%), nasal congestion (3%), nasal discomfort (6%), inflammation and swelling of the mucous membrane of the nose (≥1%)
Incidence less than 1%:
  • Cardiovascular: decrease in heartbeats, syncope.
  • Dermatologic: increase sweating of skin, pruritus, urticaria.
  • Gastrointestinal: anorexia, vomiting.
  • Genitourinary: urinary tract infection
  • Hematologic & oncologic: anemia, decrease in white blood cell count.
  • Infection: Infection.
  • Nervous system: convulsions.
  • Neuromuscular & skeletal: hyper muscle activity.
  • Respiratory: cough.
Frequency not defined:
  • Endocrine & metabolic: Change in libido
  • Gastrointestinal: altered salivation, constipation, gastrointestinal distress, hiccups, nausea
  • Genitourinary: urinary incontinence, urinary retention
  • Hematologic & oncologic: neutropenia
  • Hepatic: increase in liver function tests.
  • Nervous system: drug dependence, central nervous system depression, depression, anterograde amnesia,  drug withdrawal, dysarthria, fatigue, hypoactivity, paradoxical central nervous system stimulation, psychiatric signs and symptoms, vertigo, slurred speech
  • Neuromuscular & skeletal: Tremor
  • Ophthalmic: Blurred vision, diplopia
Contraindications
  • untreated open-angle glaucoma.
  • infants <6 months of age.
  • myasthenia gravis.
  • severe respiratory impairment.
  • severe hepatic impairment.
  • sleep apnea syndrome.

        Pregnancy Considerations

Valium crosses the placenta. Teratogenic effects have been observed with Valium; however, more studies are needed. The incidence of low birth and premature birth weights may be increased following maternal use of Valium.

Hypoglycemia and respiratory problems are common with the neonate following exposure late in pregnancy. Neonatal withdrawal symptoms may occur within days to weeks after birth. Monotherapy with the lowest dose should be considered in women with epilepsy. Avoidance of medications with a high incidence of teratogenic effects is recommended.

Breast-Feeding Considerations

Valium and its metabolites are present in breast milk.

Sedation and weight loss have been observed in some infants exposed to Valium via breast milk. 

Valium has a long half-life and may accumulate in the breastfed infant, especially preterm infants or those exposed to chronic maternal doses. Significant accumulation may occur even if the maternal dose is low. A single maternal dose may be compatible with breastfeeding.