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The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In patients taking DAYPRO ALTA (oxaprozin potassium tablets), oxaprozin, or other NSAIDs , the following are the most frequently reported adverse experiences occurring in approximately 1-10% of patients [see Clinical Studies]:
Gastrointestinal experiences including: abdominal pain, anorexia, constipation, diarrhea, dyspepsia, flatulence, gross gastrointestinal bleeding/perforation, GI ulcers (gastric/duodenal), heartburn, nausea, vomiting.
Non-gastrointestinal experiences including: abnormal renal function, anemia, confusion, depression, disturbance of sleep, dizziness, dysuria or frequency, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, sedation, somnolence, tinnitus.
Additional Adverse Experiences Reported In Less Than 1% Of Patients:
Body as a whole: anaphylactic reactions, appetite changes, death, fever, infection, sepsis, serum sickness.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, hemorrhoidal or rectal bleeding, hepatitis, jaundice, liver failure, pancreatitis, stomatitis.
Metabolic and nutritional: hyperglycemia, weight changes.
Skin and appendages: alopecia. angioedema, increased sweating, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’ssyndrome), urticaria.
Special senses: blurred vision, conjunctivitis, hearing impairment.
Urogenital system: acute interstitial nephritis, acute renal failure, cystitis, decreased menstrual flow, hematuria, increase in menstrual flow, nephrotic syndrome, oliguria/polyuria, proteinuria, renal insufficiency.
Read the Daypro Alta (oxaprozin) Side Effects Center for a complete guide to possible side effects
See Table 1 for clinically significant drug interactions with oxaprozin potassium [see CLINICAL PHARMACOLOGY].
Table 1: Clinically Significant Drug Interactions with Oxaprozin Potassium
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of DAYPRO ALTA with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].|
|Intervention:||Concomitant use of DAYPRO ALTA and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. DAYPRO ALTA is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of DAYPRO ALTA with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||The concomitant use of oxaprozin potassium with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of DAYPRO ALTA and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of DAYPRO ALTA and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction) because NSAID administration may result in increased plasma levels of methotrexate, especially in patients receiving high doses of methotrexate.|
|Intervention:||During concomitant use of DAYPRO ALTA and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of DAYPRO ALTA and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of DAYPRO ALTA and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of oxaprozin potassium with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].|
|Intervention:||The concomitant use of oxaprozin potassium with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of DAYPRO ALTA and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
During concomitant use of DAYPRO ALTA and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.
In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
|Clinical Impact:||Concomitant use of corticosteroids with DAYPRO ALTA may increase the risk of GI ulceration or bleeding.|
|Intervention:||Monitor patients with concomitant use of DAYPRO ALTA with corticosteroids for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||While oxaprozin does alter the pharmacokinetics of glyburide, coadministration of oxaprozin to type II non-insulin dependent diabetic patients did not affect the area under the glucose concentration curve nor the magnitude or duration of control.|
|Intervention||During concomitant use of DAYPRO ALTA and glyburide, monitor patients’ blood glucose in the beginning phase of cotherapy.|
Laboratory Test Interactions
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking oxaprozin. This is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of oxaprozin therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish oxaprozin from benzodiazepines.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/21/2016
Additional Daypro Alta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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