Cats: A field study involving 138 cats was conducted. Of the 72 cats receiving meloxicam injection, six cats (8.3%) experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. Nine cats (12.5%) receiving meloxicam Injection had post-treatment anemia. Pre-treatment, these cats all had hematocrit and hemoglobin values in the normal range. Four cats (6.1%) in the butorphanol treatment group had post-treatment anemia. All but one cat, who had a mild anemia pre-treatment (hematocrit = 21% and hemoglobin = 7.0 g/dL) had normal pre-treatment values. Twenty-four hours after the injection with meloxicam injection, one cat experienced pain upon palpation of the injection site.
Foreign Experience:
Repeated use in cats has been associated with acute renal failure and death. In studies used for the foreign approval of meloxicam injection in cats, lethargy, vomiting, inappetence, and transient pain immediately after injection were noted. Diarrhea and fecal occult blood have also been reported.
Post-Approval Experience (Rev. 2009):
The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:
Urinary: azotemia, elevated creatine, elevated phosphorus, renal failure
Gastrointestinal: anorexia, vomiting, diarrhea
Neurologic/Behavioral: lethargy, depression
Hematologic: anemia
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats.
CONTACT INFORMATION:
To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Covetrus® North America at (855) 724-3461or covetrus.com.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
Meloxicam Injection 5 mg/mL Solution for Injection
Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetence) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have experienced more than one episode of the adverse reaction during the study.
In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Post-Approval Experience (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system.
Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral: lethargy, depression
Hepatic: elevated liver enzymes
Dermatologic: pruritus
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with use of meloxicam in cats.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
Metacam® (meloxicam oral suspension) 1.5 mg/mL
Dogs: A field study involving 224 dogs was conducted. Based on the results of this study, GI abnormalities (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the study. Dogs may have experienced more than one episode of the adverse reaction during the study.
In foreign suspected adverse drug reaction (SADR) reporting, adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Post-Approval Experience (Rev. 2009):
The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:
Gastrointestinal: vomiting, diarrhea, melena, gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral: lethargy, depression
Hepatic: elevated liver enzymes
Dermatologic: pruritus
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc.,1-888-637-4251.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
Metacam® (meloxicam) 5 mg/mL Solution for Injection
The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system.
Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral: lethargy, depression
Hepatic: elevated liver enzymes
Dermatologic: pruritus
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with use of meloxicam in cats.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
Metacam® (meloxicam oral suspension)0.5 mg/mL
Adverse Reactions: Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetence) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have experienced more than one episode of the adverse reaction during the study. In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Adverse Reactions Observed During Two Field Studies
Clinical Observation
Meloxicam (n = 157)
Placebo (n = 149)
Vomiting
40
23
Diarrhea/Soft Stool
19
11
Bloody Stool
1
0
Inappetance
5
1
Bleeding Gums After Dental Procedure
1
0
Lethargy/Swollen Carpus
1
0
Epiphora
1
0
Meloxidyl® (meloxicam oral suspension) 1.5 mg/mL
Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have experienced more than one episode of the adverse reaction during the study.
Adverse Reactions Observed During Two Field Studies
Clinical Observation
Meloxicam
(n=157)
Placebo
(n=149)
Vomiting
40
23
Diarrhea/Soft Stool
19
11
Bloody Stool
1
0
Inappetance
5
1
Bleeding gums after dental procedure
1
0
Lethargy/Swollen Carpus
1
0
Epiphora
1
0
In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Professional Insert
Adverse Reactions:
Dogs: A field study involving 224 dogs was conducted. Based on the results of this study, GI abnormalities (vomiting, soft stools, diarrhea, and inappetence) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the study. Dogs may have experienced more than one episode of the adverse reaction during the study.
Adverse Reactions Observed During Field Study
Clinical Observation
Meloxicam (n = 109)
Placebo (n = 115)
Vomiting
31
15
Diarrhea/Soft Stool
15
11
Inappetence
3
0
Bloody Stool
1
0
In foreign suspected adverse drug reaction (SADR) reporting, adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Meloxivet™ (meloxicam) 5 mg/mL Solution for Injection
Adverse Reactions:
Cats: A field study involving 138 cats was conducted. Of the 72 cats receiving meloxicam injection, six cats (8.3%) experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. Nine cats (12.5%) receiving meloxicam Injection had post-treatment anemia. Pre-treatment, these cats all had hematocrit and hemoglobin values in the normal range. Four cats (6.1%) in the butorphanol treatment group had post-treatment anemia. All but one cat, who had a mild anemia pre-treatment (hematocrit=21% and hemoglobin=7.0 g/dL) had normal pre-treatment values. Twenty-four hours after the injection with meloxicam injection, one cat experienced pain upon palpation of the injection site.
Meloxivet™ (meloxicam) 5 mg/mL Solution for Injection
The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:
Urinary: azotemia, elevated creatinine, elevated phosphorus, renal failure
Gastrointestinal: anorexia, vomiting, diarrhea
Neurologic/Behavioral: lethargy, depression
Hematologic: anemia
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc., 1-888-637-4251.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
.
Metacam® (meloxicam) 5 mg/mL Solution for Injection
Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetence) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have experienced more than one episode of the adverse reaction during the study.
In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Metacam® (meloxicam oral suspension)0.5 mg/mL
Repeated use in cats has been associated with acute renal failure and death. In studies used for the foreign approval of METACAM Injection in cats, lethargy, vomiting, inappetance, and transient pain immediately after injection were noted. Diarrhea and fecal occult blood have also been reported.
Metacam® (meloxicam) 5 mg/mL Solution for Injection