My name is David and I almost died while having a seizure as a result of mycolonoscopypreparation usingOSMOPREP®. I am 53 years old and had my last colonoscopy 8 years ago. I was due for another. During my first colonoscopy, I had no adverse side effects from any aspect of the prep or the procedure.
I visited my proctologist in Murrieta CA who recommended using the drugOSMOPREPto clean out my system prior to the colonoscopy. He told me that I would far prefer the tablet approach rather than drinking the gallon of liquid prep (Nulytely) for the procedure. The doctor didn't suggest that there could be any potential bad reactions to the medication. When I picked up the medication at the pharmacy, the warnings didn't suggest how bad the side effects could be.
My wife was very concerned that I follow the directions very closely while prepping for mycolonoscopy. First we read the directions. Next, I went online to make sure that if I was going to take 4 tablets every 15 minutes, that the manufacturer really suggested so many pills. They did. So I started the regimen early in the day by drinking lots of water (three 44 oz. glasses of water). At 6pm I started taking 4OSMOPREPtablets every 15 minutes with a 12 oz glass of water. Getting down all that water was hard.
After taking the tablets for 45 minutes, my back started to burn. My wife scratched it for me but the itching became more severe. Next my face got real itchy and irritated. I went upstairs and shaved hoping that with a clean face, the irritation on my face would go away. By the time I finished shaving, my feet started to itch. I tried scratchimg them on a rough rug. That didn't do any good. They started to burn. Next I went outside to scratch them on the concrete -- once again, it just got worse.
Within 10 minutes of the itching symptoms, I started to get light headed. I had my wife call 911. She hung up before they answered the call as she thought she might want to call the doctor first to ask about the problems were were having with ourcolonoscopy prepusing OSMOPREP. 911 called back and asked if we had called and if we had an emergency. By that time, I had started to throw up. My wife had them send an ambulance. A minute later, my wife watched as my eyes rolled to the top of my head, I passed out, and my bowls let loose. She was panicked. She quickly went to open the front door so that emergency people could come in on their own. They arrived within 5 minutes.
When the emergency people finally arrived, they found me passed out in the bathroom in a mess of my own vomit and feces. They took my vitals and put me into the ambulance. They tried to give me intravenous fluids but even with three attempts could not get a needle into my veins as they had collapsed. After being rolled into the emergency room, the nurses tried to get an IV started but failed three more times. At this point, they got the senior nurse on the floor to try and after another three tries, got the IV started. They said that theOSMOPREPhad dehydrated me to the point that my veins had collapsed.
I was out of consciousness for hours at the hospital. At about 3am the next morning, I was released. The next day I informed the proctologist doctor of what I had been through withOSMOPREPand he convinced me to have the procedure since I had already gone through so much. The procedure went without a hitch.
Since my experiance withOSMOPREP, I had had low energy and slept more hours than was typical for me. My routine was to go to bed early and sleep 7 to 7.5 hour nights. The next morning I was up by 6am and be back in bed by 8am for a three hour nap. If I missed my morning map, I would be in physical pain until I took a nap. I visited my general doctor and he said that the recovery period was expected based on what I had been through. I have the feeling that there is something more wrong but I don't know what?
Last week, I received an ambulance bill of $1800 and a hospital bill of $2591. WOW -- I was not ready for that after my experiance. I talked toSalix Pharmaceuticals Corporate Headquartersin Morrisville, North Carolina and they offered to reimburse me for the cost of the pills but none of my other costs. I informed them that I had a lot of bills as a result of theirOSMOPREPdrug and thought they should have taken responsibility since there was no warning that the potential side effects of the drug were so severe.
FDA WARNINGS
FDA BLACK BOX WARNINGS FROM USING OSMOPREP
On December 11 2008 the FDA announced that it had ordered a Black Box Warning, its most serious caution, for both Visicol® andOsmoPrep®. Here is the text of the Black Box Warning, which must now be displayed on all prescribing literature for these medications:There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with age 55 years and above, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, Angiotensin converting enzyme [ACE] inhibitors, Angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).
GENERAL CONSIDERATIONS FROM USING OSMOPREP
Administration of sodium phosphate products prior to colonoscopy for colon cleansing has resulted in
fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias.
These fatalities have been observed in patients with renal insufficiency, in patients with bowel
perforation, and in patients who misused or overdosed sodium phosphate products. It is recommended
that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of
OsmoPrep.
Considerable caution should be advised beforeOsmoPrepTM Tablets are used in patients with the
following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute),
congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute bowel obstruction,
pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic
megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium,
creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including
those with history of renal insufficiency, history of ? or at greater risk of ? acute phosphate
nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy,
prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia,
hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting and/or signs of
dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine,
and BUN).
RENAL DISEASE, ACUTE PHOSPHATE NEPHROPATHY AND
ELECTROLYTE DISORDERS FROM USING OSMOPREP
There have been rare, but serious, reports of renal failure and acute phosphate nephropathy (also
known as nephrocalcinosis) in patients who received oral sodium phosphate products (including oral
sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often
resulted in permanent impairment of renal function and several patients required long-term dialysis.
Patients at increased risk of acute phosphate nephropathy may include patients with the following:
hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal
perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin
receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).
UseOsmoPrepwith caution in patients with impaired renal function, patients with a history of acute
phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people
taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with
electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
should have their electrolytes corrected before treatment with OsmoPrep Tablets.
SEIZURES WHILE USING OSMOPREP
There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness
associated with use of sodium phosphate products in patients with no prior history of seizures. The
seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia,
hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities
resolved with correction of fluid and electrolyte abnormalities. OsmoPrep should be used with caution
in patients with a history of seizures and in patients at higher risk of seizure [patients using
concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients
withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].
Cardiac Arrhythmias
There have been rare, but serious, reports of arrhythmias associated with the use of sodium phosphate
products.OsmoPrepshould be used with caution in patients with higher risk of arrhythmias (patients
with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled
arrhythmias, and patients with a recent history of a myocardial infarction). Pre-dose and post-
colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.
For more information onOSMOPREP, you might want to look atSalix Pharmaceuticalsweb site at http://osmoprep/" or call them at 919-862-1000. I doubt that my experience was unique. To read more about my case, check out .
