"(Reuters) - Sanofi SA and Regeneron Pharmaceuticals Inc on Friday said U.S. regulators had declined to approve their experimental treatment for rheumatoid arthritis because of manufacturing deficiencies.
The companies, in a release, s"...
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 FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:
Cardiovascular System: Edema
Nervous System: Dizziness, headache, vertigo
Skin and Appendages: Pruritus, rash
Special Senses: Tinnitus
Additional adverse experiences reported occasionally include:
Cardiovascular System: Palpitations
Digestive System: Stomatitis
Nervous System: Drowsiness
Special Senses: Blurred vision
The following adverse reactions have been identified during post approval use of FELDENE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis
Hemic and Lymphatic System: Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Hypersensitivity: Positive ANA
Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence,
tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations
Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction
Special Senses: Conjunctivitis, hearing impairment, swollen eyes
Reproductive system and breast disorders: Female fertility decreased
Read the Feldene (piroxicam) Side Effects Center for a complete guide to possible side effects
See Table 1 for clinically significant drug interactions with piroxicam.
Table 1: Clinically Significant Drug Interactions with Piroxicam
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of FELDENE 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 FELDENE and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS].
FELDENE 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 FELDENE 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 piroxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of FELDENE 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 FELDENE 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).|
|Intervention:||During concomitant use of FELDENE and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of FELDENE and cyclosporine may increase cyclosporine's nephrotoxicity.|
|Intervention:||During concomitant use of FELDENE and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of piroxicam 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 piroxicam with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of FELDENE and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
During concomitant use of FELDENE 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.
|Highly Protein Bound Drugs|
|Clinical Impact:||FELDENE is highly protein bound and, therefore, might be expected to displace other protein bound drugs.|
|Intervention:||Physicians should closely monitor patients for a change in dosage requirements when administering FELDENE to patients on other highly protein bound drugs.|
|Clinical Impact:||Concomitant use of corticosteroids with FELDENE may increase the risk of GI ulceration or bleeding.|
|Intervention:||Monitor patients with concomitant use of FELDENE with corticosteroids for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
Read the Feldene Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/13/2016
Additional Feldene Information
Feldene - User Reviews
Feldene User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Get the latest treatment options