Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data.
For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described.
Chambers
Christina D
CD
Department of Pediatrics, University of California, San Diego, CA, USA. chchambers@ucsd.edu
Tutuncu
Zuhre N
ZN
Johnson
Diana
D
Jones
Kenneth L
KL
D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing
D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents