"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
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 ratesobserved in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled trials during the premarketing development of FLECTOR PATCH, approximately 600 patients with minor sprains, strains, and contusions were treated with FLECTOR PATCH for up to two weeks.
Adverse Events Leading To Discontinuation Of Treatment
In the controlled trials, 3% of patients in both the FLECTOR PATCH and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the FLECTOR PATCH and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.
Common Adverse Events
Overall, the most common adverse events associated with FLECTOR PATCH treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of FLECTOR PATCH. A majority of patients treated with FLECTOR PATCH had adverse events with a maximum intensity of “mild” or “moderate.”
Table 1: Common Adverse Events (by body system and
preferred term) in ≥ 1% of Patients treated with FLECTOR PATCH or Placebo
|Application Site Conditions||64||11||70||12|
|Nervous System Disorders||13||2||18||3|
|Other 4||4||1||3||< 1|
|1 The table lists adverse events occurring in
placebo-treated patients because the placebo-patch was comprised of the same
ingredients as FLECTOR PATCH except for diclofenac. Adverse events in the
placebo group may therefore reflect effects of the non-active ingredients.
2 Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles.
3 Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
4 Includes: hypoesthesia, dizziness, and hyperkinesias.
Foreign labeling describes that dermal allergic reactions may occur with FLECTOR PATCH treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.
Read the Flector Patch (diclofenac epolamine topical patch) Side Effects Center for a complete guide to possible side effects
See Table 2 for clinically significant drug interactions with diclofenac.
Table 2: Clinically
Significant Drug Interactions with Diclofenac
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of FLECTOR PATCH 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 FLECTOR PATCH and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. FLECTOR PATCH is not a substitute for low dose aspirin for cardiovascular protection.|
|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 FLECTOR PATCH 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 diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of FLECTOR PATCH 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 FLECTOR PATCH 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 FLECTOR PATCH and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of FLECTOR PATCH and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of FLECTOR PATCH and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of diclofenac 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 diclofenac with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of FLECTOR PATCH and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of FLECTOR PATCH 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.
Last reviewed on RxList: 6/7/2016
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