...been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (.ñaméis) of species) when given in doses (x) times the human...fetus." The labeling shall contain a description of the a.nimn.1 studies. If there are no animal reproduction studies and no adequate and well-controlled studies...

...(x) times the human dose. There are no adequate and wellcontrolled studies in pregnant women. (Nome of drug] should be used during pregnancy only if the...studies and no adequate and well-controlled studies in humant, the labeling shall state: "Pregnancy Category C. Animal reproduction studies have not been...

...human exposure based on the AUCo-24 at 200 mg BID). There are no studies in pregnant women. CELEBREX should be used during pregnancy only if the potential benefit justifies the potential risk to the ; etus. Nonteratogenic effects: Celecoxib produced preimplantation and post-implantation losses and...

.... [On pregnancy:] There are no adequate and well controlled studies in pregnant women. Cyclosporine should be used during pregnancy only if the potential...benefit justifies the potential risk to the fetus. Azathioprine Azathioprine is an imidazole derivative of 6-mercaptopurine. Its active metabolites cross...

...and the embryo, fetus, or neonate (see Opiate Analgesics General Monograph). Prescribe buprenorphine during pregnancy only if the potential benefit justifies the potential risk to the embryo, fetus, or neonate. Collaboration with the patient's obstetrician is indicated. Women who are...

...pregnancy Crixivan has not been studied in pregnant women. Until additional data become available, Crixivan should be used during pregnancy only if the potential...benefit justifies the potential risk to the fetus. Hyperbilirubinaemia, reported predominantly as elevated indirect bilirubin, has occured in 10% of patients...

...Pregnancy and lactation: • Corticosteroids are classified in FDA pregnancy category C and should be given only if the potential benefit justifies the potential risk to the fetus • Fetal adrenal hypoplasia may occur with large doses of corticosteroids for prolonged periods during...

...humans, or animal studies are either positive for fetal risk or lacking as well. Drugs should be given only if the potential benefit justifies the potential risk to the fetus There is positive evidence of human fetal risk. Nevertheless, potential benefits may outweigh the potential...

...to the fetus with no controlled human studies). The drug labeling states that Marinol should be used only if the potential benefit justifies the potential risk to the fetus. Likewise, its use in nursing mothers is not recommended since Marinol is concentrated in and secreted...

...reaction to salicylates or any other NSAID. Asthmatics are at particular risk for these reactions. NSAIDs should be used during pregnancy only if the potential benefit justifies the risk to the fetus. A significant number of drug interactions are common to most of the NSAIDs. The...