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Meloxicam Pregnancy and Breastfeeding Warnings

Meloxicam is also known as: Anjeso, Mobic, Qmiiz ODT, Vivlodex

Meloxicam Pregnancy Warnings

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.

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.

Avoid use during last trimester of pregnancy
Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus

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

Risk Summary: NSAIDs including this drug, should not be used in pregnant women starting at 30 weeks of gestation due to increased risk of premature closure of the fetal ductus arteriosus; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Comments:
-Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility; based on their mechanism of action, NSAIDs may impair fertility.

See references

Meloxicam Breastfeeding Warnings

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.

See references

References for pregnancy information

  1. "Product Information. Mobic (meloxicam)" Boehringer-Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  4. "Product Information. Anjeso (meloxicam)." Baudax Bio, Inc., Malvern, PA.

References for breastfeeding information

  1. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Anjeso (meloxicam)." Baudax Bio, Inc., Malvern, PA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  5. "Product Information. Mobic (meloxicam)" Boehringer-Ingelheim, Ridgefield, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.