7 Interactions found for:

The following applies to the ingredients: Lorazepam

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Use should be avoided.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: This drug may increase the risk of fetal malformations and/or withdrawal symptoms.

Comments:
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
-Neonates who are exposed to chronic benzodiazepine use may be at risk for withdrawal symptoms.
-There have been reports of floppy infant syndrome (e.g., apnea, feeding difficulties, hypothermia, hypotonia/neonatal flaccidity, impaired metabolic response to cold stress, moderate respiratory depression) in children born to mothers who have taken high doses of this drug late in pregnancy or during labor; some infants may require treatment with a ventilator at birth.
-Glucuronidation of this drug may competitively inhibit the conjugation of bilirubin, leading to hyperbilirubinemia in neonates.

Animal studies have shown occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia). There are no adequate studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Pregabalin (found in Lyrica)

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This drug should only be given during pregnancy when there are no alternatives and benefit outweighs risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate and well-controlled studies in pregnant women; animal reproduction studies have shown increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity.

Comment:
-Patients should be advised of the potential risk to a fetus.
-Women of childbearing potential should be encouraged to use reliable contraception during treatment.
-Physicians should encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; toll free 1-888-233-2334 or http://www.aedpregnancyregistry.org/

Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including skeletal malformations, retarded ossification, and decreased fetal body weight have been observed in rat and rabbit offspring receiving this drug at 18 times or greater the maximum recommended dose during organogenesis. Lethality, growth retardation, and nervous and reproductive system functional impairment have been observed in rat offspring receiving this drug during gestation and lactation. Rat offspring tested as adults, showed neurobehavioral abnormalities (decreased auditory startle responding). There are no controlled data in human pregnancy.

A clinical trial in healthy male subjects found that 3 months of taking this drug at 600 mg/day did not effect sperm motility. Adverse reproductive and developmental effects have been observed in male rats.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Lorazepam

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Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines.
-Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern if exposure is prolonged.

The following applies to the ingredients: Pregabalin (found in Lyrica)

Professional Content

Breastfeeding is not recommended

Excreted into human milk: Yes

Comment:
-Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment.

Limited data have shown the estimated average daily infant dose expected from breast milk is about 7% of the maternal weight adjusted dose. An unexpectedly high incidence of hemangiosarcoma was observed in standard preclinical in vivo lifetime carcinogenicity studies in 2 different strains of mice. The clinical significance of this finding is unknown.