FENOPROFEN

Drugs in Pregnancy and Lactation.

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Name: FENOPROFEN
Class: Nonsteroidal Anti-inflammatory
Risk Factor:    B*

Fetal Risk Summary

Fenoprofen is a nonsteroidal anti-inflammatory drug (NSAID) in the same subclass (propionic acids) as five other agents (flurbiprofen, ibuprofen, ketoprofen, naproxen, and oxaprozin). It is indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis (1). Fenoprofen given to rats during pregnancy and continued until labor resulted in prolonged parturition (1).

It is not known if fenoprofen crosses the human placenta. The molecular weight (about 559) is low enough that passage to the fetus should be expected. However, in one study the drug was used during labor (2). No data were given except that the drug could not be detected in cord blood or amniotic fluid.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 191 newborns had been exposed to fenoprofen during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of six (3.1%) major birth defects were observed (eight expected), including (observed/expected) 1/2 cardiovascular defects and 1/1 polydactyly. No anomalies were observed in four other categories of defects (oral clefts, spina bifida, limb reduction defects, and hypospadias) for which specific data were available. These data do not support an association between the drug and congenital defects.

A combined 2001 population-based observational cohort study and a case-control study estimated the risk of adverse pregnancy outcome from the use of NSAIDs (3). The use of NSAIDs during pregnancy was not associated with congenital malformations, preterm delivery, or low birth weight, but a positive association was discovered with spontaneous abortions (SABs) (see Ibuprofen for details).

Prostaglandin synthesis inhibitors can theoretically cause constriction of the ductus arteriosus in utero (see also Indomethacin) (4). Persistent pulmonary hypertension of the newborn may occur if these agents are used in the 3rd trimester close to delivery (4). These drugs also have been shown to inhibit labor and prolong pregnancy, both in humans (5) (see also Indomethacin), and in animals (6). Women attempting to conceive should not use any prostaglandin synthesis inhibitor, including fenoprofen, because of the findings in a variety of animal models that indicate these agents block blastocyst implantation (7,8). Moreover, as noted above, NSAIDs have been associated with SABs.

[*Risk Factor D if used in the 3rd trimester or near delivery.]

Breast Feeding Summary

Fenoprofen passes into breast milk in very small quantities. The milk:plasma ratio in nursing mothers given 600 mg every 6 hours for 4 days was approximately 0.017 (2). Although the clinical significance of this amount is unknown, another NSAID in the same subclass is considered compatible with breast feeding by the American Academy of Pediatrics (see Ibuprofen).

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World’s leading meds delivered to your door – and you don’t even need a prescription! Only certified, first class drugs on offer! Buy more and spend less with our great discount system.

References

  1. Product information. Nalfon. Dista Products, 2001.
  2. Rubin A, Chernish SM, Crabtree R, et al. A profile of the physiological disposition and gastro-intestinal effects of fenoprofen in man. Curr Med Res Opin 1974;2:529–44.
  3. Nielsen GL, Sorensen HT, Larsen H, Pedersen L. Risk of adverse birth outcome and miscarriage in pregnant users of nonsteroidal antiinflammatory drugs: population based observational study and case-control study. Br Med J 2001;322:266–70.
  4. Levin DL. Effects of inhibition of prostaglandin synthesis on fetal development, oxygenation, and the fetal circulation. Semin Perinatol 1980;4:35–44.
  5. Fuchs F. Prevention of prematurity. Am J Obstet Gynecol 1976;126:809–20.
  6. Powell JG, Cochrane RL. The effects of a number of non-steroidal anti-inflammatory compounds on parturition in the rat. Prostaglandins 1982;23:469–88.
  7. Matt DW, Borzelleca JF. Toxic effects on the female reproductive system during pregnancy, parturition, and lactation. In Witorsch RJ, editor. Reproductive Toxicology. 2nd ed. New York, NY:Raven Press, 1995:175–93.
  8. Dawood MY. Nonsteroidal antiinflammatory drugs and reproduction. Am J Obstet Gynecol 1993;169:1255–65.

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