Label Changes for:
Mobic (meloxicam) Tablets and Oral Suspension
March 2012
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2012
PRECAUTIONS
Use in Specific Populations
- Females of Reproductive Potential Data from several small studies in humans and from studies in animals indicate that NSAIDs, including Mobic, may be associated with a reversible delay in ovulation. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended
PATIENT COUNSELING INFORMATION
- Effects On Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including Mobic, may be associated with a reversible delay in ovulation For women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended
August 2011
WARNINGS AND PRECAUTIONS
Co-administration with Kayexalate (sodium polystyrene sulfonate)
- Concomitant use of sorbitol with Kayexalate (sodium polystyrene sulfonate) has been implicated in cases of intestinal necrosis (possibly fatal). Due to the presence of sorbitol in Mobic Oral Suspension, use with Kayexalate is not recommended.
DRUG INTERACTIONS
Kayexalate (sodium polystyrene sulfonate)
- Cases of intestinal necrosis (possibly fatal) have been described in patients who received concomitant sorbitol and Kayexalate (sodium polystyrene sulfonate). Due to the presence of sorbitol in Mobic Oral Suspension, use with Kayexalate is not recommended.
