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WOULD YOU TAKE THIS DRUG? GUESS WHICH IT IS. ANSWER AT END.

What follows is excerpted and simplified from the package insert of one of the most widely used drugs around.

Probably you take this drug frequently without giving it much thought. BIG MISTAKE!

Bet you never read the packet insert.

Bet the bottle is sitting in your medicine cabinet, in your pocket, or purse.

Bet you would think twice about taking it if was prescribed by your doctor and your doctor explained what you'll read below.

I've removed the name of the drug in the content below and replaced it with 'X'.

CARDIOVASCULAR EFFECTS:

Cardiovascular Thrombotic (CLOT) Events

Clinical trials of 'X' of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events (CLOTS), myocardial infarction (HEART ATTACK), and stroke, which can be fatal.

The concurrent use of aspirin and'X' does increase the risk of serious GI events (see Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation).

Two large, controlled clinical trials of 'X' for the treatment of pain in the first 10 to 14 days following CABG (HEART) surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

 

Hypertension

'X' can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking 'X'.

'X' should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of 'X' treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention, edema, and peripheral edema have been observed in some patients taking 'X'

'X' should be used with caution in patients with fluid retention, hypertension, or heart failure.

Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation

'X' can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.

These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with 'X'.

Only one in five patients, who develop a serious upper GI adverse event on 'X', is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by'X' occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

'X'should be taken with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.

Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use'X' have a greater than 10 fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with'X' include concomitant use of oral corticosteroids or anticoagulants,smoking, use of alcohol, older age, and poor general health status.

Renal Effects

Long-term use of 'X' has resulted in KIDNEY FAILURE.

Anaphylactoid Reactions (SUDDEN DEATH)

Anaphylactoid reactions may occur in patients without known prior exposure to 'X'.

'X' should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or 'X' (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.

Skin Reactions

'X' can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy 'X' should be avoided because they may cause premature closure of the ductus arteriosus (BIRTH DEFECT).

Precautions

Hepatic (LIVER) Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking 'X'.

In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with 'X'.

Hematological Effects

Anemia is sometimes seen in patients receiving 'X'. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with 'X', should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

Adverse Reactions

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg of 'X' compared to those taking 750 mg of 'X' .

In patients taking 'X'  in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*2, abdominal pain*2, nausea*2, constipation*2, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*2, dizziness*2, drowsiness*2, lightheadedness, vertigo

Dermatologic: pruritus (itching)*2, skin eruptions*2, ecchymoses*2, sweating, purpura

Special Senses: tinnitus*2, visual disturbances, hearing disturbances

Cardiovascular: edema*2, palpitations

General: dyspnea*2, thirst

 

In patients taking 'X', the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in < 1% of patients taking 'X' during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, peptic ulceration

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (female): infertility

 

In patients taking 'X', the following adverse experiences have also been reported in < 1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria

WELL, 'X' IS NAPROXEN SODIUM, MOST COMMONLY SOLD AS ALEVE.

HOWEVER, THIS DRUG IS SOLD UNDER MANY OTHER NAMES AND IN COMBINATION WITH MANY OTHER DRUGS.

THE ABOVE ARE ONLY A SMALL SAMPLE OF THE CONCERNS YOU SHOULD HAVE ABOUT ALEVE, AND SIMILAR DRUGS LIKE ADVIL. The list is not complete.

HERE ARE SOME LINKS FOR MORE INFORMATION;

http://www.drugs.com/naproxen.html

http://www.medicinenet.com/naproxen/article.htm

 

PRACTICE HEALTH DEFENSE:

WHEN BUYING AN OTC PAIN RELIEVER ALWAYS DISCUSS THE ACTIVE INGREDIENTS WITH THE PHARMACIST-PARTICULARLY ASK IF ANY ARE THE CHEMICAL EQUIVALENTS OF ALEVE (naproxen)OR ADVIL (ibuprofen).

REMEMBER THAT THESE CHEMICALS CAN BE HIDDEN INGREDIENTS IN SEEMINGLY HARMLESS OTC FORMULATIONS.

ASK THE PHARMACISTS ABOUT DRUG INTERACTIONS WITH YOUR USUAL MEDS.

DO NOT FORGET THAT HERBS AND SUPPLEMENTS ARE DRUGS TOO AND CAN INTERACT WITH ALL OTHER MEDICATIONS-DISCUSS EVERYTHING YOU TAKE WITH THE PHARMACIST.

TELL YOUR PHYSICIAN IF YOU ARE TO TAKE AN ALEVE-LIKE OR ADVIL-LIKE MEDICATION. IF YOUR DOCTOR PRESCRIBES THESE GO OVER THIS LIST WITH HIM OR HER.

TYLENOL (acetominophen), THOUGH IT CAN BOTHER THE LIVER AT LOW DOSES AND DAMAGE AND KILL THE LIVER AT HIGH DOSES, IS A RELATIVELY SIMPLER DRUG.

TAKE ONLY WHAT YOU ABSOLUTELY KNOW AND NEED.

Posted on Saturday, November 15, 2008 at 12:22PM by Registered CommenterDr. Lou | CommentsPost a Comment

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