Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. See below for a comprehensive list of adverse effects. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. The optimum times for making the first and subsequent transaminase measurement are not known. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:Audience: Consumer, Health Professional, Emergency MedicineReumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. A patient’s need for symptomatic relief and response to treatment should be re-evaluated periodically.Diclofenac is available to buy in a pharmacy without a prescription at low doses (up to 75 mg/day) for short-term use (3 days). FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug.

The following FDA safety notices may be specifically about diclofenac or relate to a group or class of drugs which include diclofenac. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. These conditions can occur without warning while you are using diclofenac… Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The lowest effective dose should be used for the shortest duration necessary to control symptoms. More frequently reported side effects include: abdominal pain, constipation, diarrhea, dyspepsia, fluid retention, nausea, and headache.

The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug. The products are manufactured by Riger Naturals S.A.
The product is marketed in a green bottle containing 30 lavender round tablets and is distributed nationwide via the internet.FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndromeBecause of the possible risks, consumers should not buy or start using these products.The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. Diclofenac topical gel is a prescription medication that’s used to treat osteoarthritis pain … The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs.Patients currently taking Bextra should contact their physicians to consider alternative treatments. We comply with the HONcode standard for trustworthy health information - The decision to prescribean NSAID should be based on an assessment of a patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness. You could have more side effects. DOSAGE AND ADMINISTRATION. In addition to websites selling “WOW,” FDA has become aware that various websites, including Reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings.

Reumofan Plus and “WOW” products are sold on various websites, including Gonepainfree.com and Browerent.com. If you are 65 or older, use diclofenac gel (1%) with care. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac.