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Report adverse events to FDA's MedWatch reporting system by completing a form on line at FDA's MedWatch
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drug side effects
Preventable Adverse Drug Reactions

Over 2 MILLION serious ADRs yearly

100,000 DEATHS yearly

ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths

Nursing home patients

ADR rate 350,000 yearly

Institute of Medicine, National Academy Press, 2000

Stevens-Johnson Info:

Side Effects

IV Immunoglobulin


Generic name: CATAFLAM and VOLTAREN

Diclofenac is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), and is primarily used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis, osteoarthritis (the most common form of arthritis), and ankylosing spondylitis (arthritis and stiffness of the spine)

Cutaneous adverse drug reactions: a 9-year study from a South Indian Hospital (Diclofenac) Adverse drug reactions (ADRs) are among the major causes of morbidity, hospital admissions, increased health care expenditure, and even death. Cutaneous ADRs account for majority of ADRs in hospitalized patients, which can be caused by a variety of drugs.

Cataflam prescribing information

Cataflam (diclofenac potassium immediate-release tablets), is a benzeneacetic acid derivative... Cataflam (diclofenac potassium immediate-release tablets) is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Cataflam, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition...

Diclofenac-Induced Rhabdomyolysis.

American Journal of the Medical Sciences. 312(2):95-97, August 1996.
Delrio, Felix G. MD; Park, Yon MD; Herzlich, Barry MD; Grob, David MD 
A case is described in which, after administration of diclofenac for 13 days for arthritis attributed to gout, the patient experienced erythema multiforme followed by muscle weakness, elevation of serum creatine phosphokinase (CPK) level from 101 to 83,770 U/L, 100% muscle isoenzyme, blood urea nitrogen (BUN) level from 15 to 87 mg/dL, creatinine level from 1.0 to 2.1 mg/dL and urine myoglobin level to 1,190 [micro]g/dL (N < 1.2)...

Cataflam - All About All
Diclofenac (marketed as Voltaren®, Voltarol® and Cataflam®) is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation, such as in arthritis or acute injury. It can also be used to reduce menstrual pain. Voltaren and Voltarol contain the sodium salt of diclofenac. In the United Kingdom Voltarol can be supplied with either the sodium salt or Potassium salt, while Cataflam in some other countries, is the potassium salt only. Diclofenac is currently one of the drugs most often used to treat painful conditions...

Pronounced: vol-TAR-en 
Generic name: Diclofenac sodium 
Other brand name: Cataflam (Diclofenac potassium) 
Why is Voltaren prescribed?

Voltaren and Cataflam are nonsteroidal anti-inflammatory drugs used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis, osteoarthritis (the most common form of arthritis), and ankylosing spondylitis (arthritis and stiffness of the spine). Voltaren-XR, the extended-release form of Voltaren, is used only for long-term treatment. Cataflam is also prescribed for immediate relief of pain and menstrual discomfort... 

OTC Painkillers Raise Death Risk After Heart Attack

The higher the dose of NSAIDs, the greater the risk, study finds 
By Amanda Gardner
HealthDay Reporter 

SUNDAY, Nov. 13 (HealthDay News) -- Taking pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs) -- including Cox-2 inhibitors such as Celebrex -- after a heart attack increases the risk of death, a new Danish study has found.

The higher the dose, the higher the risk of death, according to research presented Sunday at the American Heart Association's scientific sessions 2005 in Dallas...

Pain and Confusion 
[FINAL Edition] 

The Washington Post - Washington, D.C. 
Author: Francesca Lunzer Kritz 
Date: Sep 4, 2001 
Start Page: F.01 
Section: HEALTH TAB 
Document Types: Feature 
Text Word Count: 1271 

Abstract (Document Summary) 
A second study compared Celebrex to two other drugs commonly prescribed for arthritis: ibuprofen and diclofenac (Cataflam and Voltaren). Researchers found more heart attacks in the Celebrex group than other groups, according to Eric Topol, the study's lead author and chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, ...

Reproduced with permission of the copyright owner. Further reproduction or distribution is prohibited without permission. 

Some Anti-Inflammatory Drugs Are Safer Than Others

London, England (AHN) - A review of pain relievers has found that some are safer than others. For instance, a widely-used medicine may carry as much risk of heart disease as Vioxx, an arthritis drug taken off the market two years ago.

Diclofenac, a non-steroidal anti-inflammatory drug or NSAID has been around for decades and is widely prescribed throughout the world, particularly in Europe. Common doses were found to increase the risk of "cardiovascular events", primarily heart attack or sudden death by as much as 40%.


FDA NSAIDs Decision Memo

SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk

Executive Summary
Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2

• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.

• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.

PDR Drug information for

Cataflam Tablets

Manufacturer: Novartis
The following prescribing information is based on official labeling in effect August 2003. 
Cataflam ® (diclofenac potassium immediate-release tablets), is a benzeneacetic acid derivative. Cataflam is available as immediate-release Tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino]... 

ANDA 75-582 February 23, 2001
Eon Labs Manufacturing, Inc.
Attention: Patricia Kaufold
227-15 N. Conduit Avenue
Laurelton, NY 11413
Dear Madam:
This is in reference to your abbreviated new drug application dated February 11, 1999, submitted pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act (Act), for
Diclofenac Potassium Tablets, 50 mg....

Acute renal failure--"a well meant present from a friend"
[Article in German]
Buylaert MA, Schifferli JA.

Medizinische Klinik B, Universitatsspital Basel. buylaertm@uhbs.ch

Acute allergic interstitial nephritis (AIN) due to non-steroidal anti-inflammatory drugs (NSAID) is a well known but rare adverse drug event. Here, we describe the case of a 70 year old woman with recurrent episodes of acute renal failure...

BMC Med. 2005 Nov 29;3:17. 
Long-term use of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction in the general population.

Garcia Rodriguez LA, Gonzalez-Perez A.Centro Espanol de Investigacion Farmacoepidemiologica (CEIFE), Madrid, Spain. lagarcia@ceife.es

BACKGROUND: Recent data indicate that chronic use of coxibs leads to an increased occurrence of thrombotic cardiovascular events. This raises the question as to whether traditional non-steroidal anti-inflammatory drugs (tNSAIDs) might also produce similar hazards. Our aim has been to evaluate the association between the chronic use of NSAIDs and the risk of myocardial infarction (MI) in patients...

Risk of hospitalization

with peptic ulcer disease or gastrointestinal hemorrhage associated with nabumetone, Arthrotec, diclofenac, and naproxen in a population based cohort study
Ashworth NL, Peloso PM, Muhajarine N, Stang M.
Division of Physical Medicine and Rehabilitation, University of Alberta, Edmonton, Alberta, Canada. ashworth@cha.ab.ca
RESULTS: Compared to Arthrotec the adjusted odds of hospitalization for PUD for participants taking nabumetone was 2.6 (95% CI 1.0-6.6), diclo+coRx 6.8 (95% CI 3.5-13.4), and naproxen 7.9 (95% CI 3.9-15.9). Compared to nabumetone the adjusted odds of hospitalization for PUD for participants taking diclo+coRx was 2.7 (95% CI 1.2-6.0) and naproxen 3.1...

Peripheral Corneal Infiltrates Following Oral Diclofenac Administration

Arch Ophthalmol. 2000;118:1451-1452.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug that has been used systemically and topically for the control of many forms of inflammation. Diclofenac and other topical nonsteroidal anti-inflammatory drugs have been used topically for the control of discomfort and pain following photorefractive keratectomy.1-2 The drug has been shown to decrease corneal sensitivity following topical use.3 Peripheral corneal infiltrates have been observed following topical application of diclofenac and soft contact bandage lens following photorefractive keratectomy.1, 4 ...

 [Full Text of this Article]

Diclofenac treatment may hasten the progression of hip and knee osteoarthritis (OA).

In a recent study, scientists in the Netherlands sought to determine "the influence of the use of various types of nonsteroidal anti-inflammatory drugs (NSAIDs) on progression of osteoarthritis (OA) of the hip and knee."

"In 1,695 subjects (2,514 hips) and 635 subjects (874 knees) ages 55 years and older from the Rotterdam Study, radiographs of the hip and knee at baseline and follow-up (mean follow-up time 6.6 years) were evaluated," explained M. Reijman and coauthors working at the Erasmus Medical Center in Rotterdam.


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