5 Interactions found for:

The following applies to the ingredients: Meloxicam

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Contraindicated last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later

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

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.

Embryofetal death has been observed in rats and rabbits receiving oral doses equivalent to 0.32 and 3.4 times the maximum recommended human dose (MRHD), respectively. No teratogenic effects were observed in rats and rabbits receiving this drug during organogenesis at an oral doses equivalent to 1.3 and 13-times the MRHD. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, cardiopulmonary toxicity platelet dysfunction, pulmonary hypertension, and gastrointestinal or intracranial bleeding. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

Based on NSAIDs mechanism of action, use of NSAIDs in females may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In male rats, decreased sperm count and motility, and histopathological evidence of testicular degeneration was observed when 0.3 times the MRHD was administered for 35 days.

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: Meloxicam

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Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Some authorities advise against use due to lack of safety data in humans during lactation

Due to lack of published clinical experience during breastfeeding, other agents may be preferred. This drug has been found in the milk of lactating rats at concentrations higher than those in plasma.

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

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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.