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Benzodiazepines generally carry FDA ratings of "X- contraindicated in pregnancy" or "D-positive evidence of risk." There have been case reports of anatomical birth defects.
  • These are in the same category as PCP, "Special K" (ketamine), barbiturates and alcohol as far as their effect on the developing brain; these chemicals increase incidence of mental retardation, learning disabilities, ADHD, and the patterns associated with fetal alcohol syndrome and fetal alcohol effects
  • For benzodiazepines, the entire pregnancy is a time of risk; the first and second trimesters are commonly sensitive for teratogenic effects; the last trimester is particularly sensitive for brain effects -- apoptotic degeneration of neurons -- with life-long impact
FDA Pregnancy Categories
The use of any medication requires a risk-versus-benefit assessment. Among the risk factors complicating an assessment, pregnancy is one of the most perplexing. The FDA has created five categories to indicate the potential of a systemically absorbed drug for causing birth defects. The key differentiation among the categories is the reliability of documentation and the risk-versus-benefit ratio. Pregnancy category "X" is particularly notable. If data implicates a drug as a teratogen and the risk-versus-benefit ratio does not support use of the drug, the drug is contraindicated during pregnancy.

Pregnancy Category
A -- Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters

B -- Animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women -- or -- Animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in later trimesters

C -- Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks -- or -- There are no animal reproduction studies and no adequate studies in humans

D -- There is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks

X -- Studies in animals or humans demonstrate fetal abnormalities or adverse reaction reports indicate evidence of fetal risk; the risk of use in a pregnant woman clearly outweighs any possible benefit

General Guidelines for Use of Benzodiazepines
  • Depression and Related Mood Disorders -- Benzodiazepines are ineffective for treatment of depression and should be avoided in mood disorders due to their many negative effects on patients; benzodiazepines may worsen depression regardless of primary diagnosis

  • Anxiety Disorders -- Long-term management of anxiety disorders is best accomplished with antidepressants

  • Insomnia -- Use should be avoided in insomnia; if medication management is required, non-benzodiazepines should be used

  • Withdrawal -- Symptoms of withdrawal may include flu-like symptoms, insomnia, irritability, seizures, nausea, headache, tremor, muscle tension or cramps; these may appear during weaning, but may also appear after benzodiazepines are discontinued; withdrawal may mimic panic attacks

  • Persistent Sleep Problems -- patients with persistent sleep problems should be considered for further evaluation -- sleep lab or psychological evaluation rather than maintained on benzodiazepines
Benzodiazepine Side Effects
  • Use of benzodiazepines during pregnancy increases the risk of miscarriage and birth defects
  • Physiologic dependence may develop with as little as three weeks of use
  • The potential for impairment of daytime performance -- including anterograde amnesia or memory impairment -- should be discussed with patient
  • Conservative therapy is necessary to avoid an increased risk of falls in the elderly, drug interactions in the elderly, with patients who drink alcohol and with patients taking other medications -- especially those with sedative side effects
  • Special caution is required for patients with respiratory difficulty, suicidal tendencies or history of substance abuse
Benzodiazepine Withdrawal
A withdrawal-like event can occur with as little as one day of use and full withdrawal with three weeks of use.
  • Withdrawal symptoms include anxiety, insomnia, panic, tremor, muscle twitching, perceptual disturbances and depersonalization; profound insomnia is a sign of withdrawal rather than returning anxiety and is actually a rare symptom in anxiety

  • For patients on benzodiazepines for several weeks, careful tapering is required to avoid seizures, confusion and psychotic symptoms

 


    
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