Guest guest Posted January 17, 2012 Report Share Posted January 17, 2012 ----- Forwarded Message ----To: dreamjeanie@...Sent: Sun, October 12, 2008 7:14:07 AMSubject: Miralax letter If you look up the facts about Polyethylene glycol, the data shows how dangerous this chemical is, these are facts....................you have to understand, 8 years ago I suspected this happened to my dd, and I started investigating. Just like our Physicians say, "If there's truly a problem, it will happen again" I was right and here they are, in black and white, thousands of them, that rip my heart out. These poor children.................. There is more here, than meets the eye................ I told my husband 8 years ago that this is what I suspected and here they are, one after another, on a daily basis......................I've tried everything to give Miralax the benefit of the doubt and it shows up every time............. all the time................. everyday people write to this group and to the FDA complaing about the EXACT same symptoms I wrote to the FDA about in 2000................unlike what side affects are listed on the label. The protocol is clearly wrong................. I first contacted MedWatch and submitted the list of symptoms my dd was experiencing, then I asked for the FOIA reports, which took months to obtain and I only got back 6 people, that stated: medication error, etc. I re-submitted on a yearly basis for the next 8 years to see if anyone else was having this problem and the numbers kept climbing, now there's close to 1000 (FOIA) adverse events reports, many children have died, and many may have irreversible damage. Thanks to my petitioning the FDA, found my petition through the FDA website and called me from halfway across the US and we decided to put this group together so we could find more people, now there are 600 members on this group, and over 5000 posts. I petitioned the FDA twice, the first time, in 2001, they responded................It needs more research................the last being in March of 2008 and still haven't heard a response? It's absolutely disgusting that the Material Safety Data sheets on this chemical states "Not to ingest" or "dispose down our sewer systems" and it's combustable, but yet they've somehow had this approved for adults as a bowel prep? Then went a step further and decided to give to children................as little as months old? Thank you for sharing all your testimonies so we can better understand what this medication is doing to the people who've ingested it, especially our children. If you feel you've had an adverse reaction to Miralax, please contact MedWatch to heighten their awareness...........at 1-800-FDA-1088, ask for Konginstien. He's the one who taught me how to obtain everything I've found.................. It will take many people to make a difference and you have to understand that unless we are heard, they will never do anything about this situation, and many more children will be harmed. Once a medication is approved, they have to go through many steps like only changing the label side affects before pulling a medication and all the legalities and sequence of events that have to happen first, so by us submitting to them now, will at least get the ball rolling. Below are the FDA adverse events I've recovered from the FDA......................They can't hear us unless we speak.................we need to create an Amber alert line for medications, not a slow moving FDA....................too many people are being harmed by their slow, out of date, so called.................system!!! My heart goes out to all the families, especially the children, that have been harmed by this chemical and the doctors that are so willing to hand it out. 8 years ago when we put this group together I knew I would dread having to hear your stories, or another harmed child, and what a price for a parent to have to pay, just to prove to ourselves and our families that this indeed happened, on top of having to deal with the heart ache of what happened to your own child. I hope to find away to bring this to their attention, so they can stop harming these children and give the children that have been harmed some merit.................we all need to understand the facts about this medication and how this medication works and what happened here............... to better understand what happened to our children and what to expect for their futures. Jeanie this link has an article called "Fatal Disnatremia Caused By Elective Colonoscopy", it was written in the BMJ (British Medical Journal) which is about 3 people who received an elective colonoscopy and 2 out of the 3 patients died after ingesting PEG electrolyte solution It also has the (FOIA) Freedom of Information Act FDA adverse reactions from 1997 to present.....................containing 869 reports, and many children have died from this medication, some will have irreversible affects.................below are just a few children on them........................ Date:08/03/98ISR Number: 3111591-5Report Type:Direct Company Report # Age:4.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anion Gap Increased Golytely PS Braintree Life-Threatening Brain Oedema Laboratories Inc 2400CC PER NG Other Gastrointestinal Disorder TUBE OVER 12 Hyponatraemia HOURS Metabolic Acidosis Fentanyl C Neuropathy Peripheral Ondansetron C Date:08/23/99ISR Number: 3332612-0Report Type:Expedited (15-DaCompany Report #002#1#1999- 00294 Age:16 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Colyte-For-Oral- Solu Initial or Prolonged Medication Error Professional tion (Sodium Respiratory Disorder Bicarbonate, Potassium Chloride, Sodium Chloride, PS ORAL 4 LIT, 1 IN 1 D, ORAL Sulfamethoxazole/ Tri methoprim C Date:08/23/00ISR Number: 3556117-7Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Golytely PS 150 CC/HR PER Intervention to Blood Creatinine G-TUBE Prevent Permanent Increased Impairment/Damage Blood Urea Increased Hypotension Sluggishness Tachycardia Wound Secretion Date:10/19/00ISR Number: 3598396-6Report Type:Direct Company Report # Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Miralax Mfd By Initial or Prolonged Abnormal Behaviour Braintree Labs PS Braintree Labs SEE ITEM B5 11 DAY Antisocial Behaviour Bipolar I Disorder Convulsion Decreased Appetite Depressed Mood Disturbance In Attention Fear Feeling Cold Frequent Bowel Movements Insomnia Movement Disorder Neurological Symptom Night Sweats Obsessive-Compulsiv e Disorder Paranoia Speech Disorder Staring Throat Tightness Tremor Date:11/28/00ISR Number: 3622985-3Report Type:Periodic Company Report #000017 Age:26 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Miralax PS Braintree Laboratories Inc ORAL 8.5 GRAMS QD Date:01/25/01ISR Number: 3654131-4Report Type:Direct Company Report # Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Miralax PS ORAL 17 GRAMS ORAL Bactrim C Date:10/04/01ISR Number: 3805237-8Report Type:Expedited (15-DaCompany Report #002#4#1998- 00152(1) Age:9 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Iatrogenic Injury Health Colyte-For-Oral- Solu Hospitalization - Lung Disorder Professional tion (Polyethylene Initial or Prolonged Medication Error Other Glycol 3350) PS NASAL ONE TIME Disability Pulmonary Fibrosis DOSE, NASAL 16 HR Pulmonary Function Test Decreased Date:10/11/01ISR Number: 3808143-8Report Type:Expedited (15-DaCompany Report #002#1#2001- 00114(1) Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Colyte-For-Oral- Solu Hospitalization - Atelectasis Professional tion (Polyethylene Initial or Prolonged Implant Site Reaction Glycol 3350) PS 600ML, ONCE, Lung Infiltration OTHER Date:10/30/01ISR Number: 3817675-8Report Type:Expedited (15-DaCompany Report #002#1#2001- 00114 (2) Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Colyte-For-Oral- Solu Hospitalization - Atelectasis Professional tion (Polyethylene Initial or Prolonged Lung Infiltration Glycol 3350) PS 600 ML, ONCE, Pco2 Increased OTHER Date:02/27/02ISR Number: 3874820-6Report Type:Direct Company Report #CTU 162452 Age:3 YR Gender:Male I/FU:I Outcome PT Other Abnormal Behaviour Abnormal Faeces Aggression Balance Disorder Constipation Crying Dysarthria Emotional Disorder Euphoric Mood Feeling Hot Hyperhidrosis Inappropriate Affect Motor Dysfunction Movement Disorder Obsessive Thoughts Paraesthesia Paranoia 18-Apr-2007 11:25 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychomotor Hyperactivity Rash Maculo-Papular Screaming Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Miralax Peg 3350 Sleep Disorder Braintree Speech Disorder Laboratories PS Braintree Tic Laboratories ORAL 17GRAMS PER DAY ORAL Colyte C Date:03/05/02ISR Number: 3879778-1Report Type:Direct Company Report #CTU 162783 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Miralax Mfd By Initial or Prolonged Electrolyte Imbalance Braintree Labs PS Braintree Labs 11 DAY Pain Paranoia Tic Tooth Disorder Tremor Date:03/28/02ISR Number: 3892204-1Report Type:Expedited (15-DaCompany Report #020006 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Golytely PS ORAL 4 LITERS PO Initial or Prolonged Asthenia Coma Haematochezia Mallory-Weiss Syndrome Mouth Haemorrhage Nausea Rectal Haemorrhage Syncope Vomiting Date:04/26/02ISR Number: 3907546-0Report Type:Direct Company Report #CTU 166738 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Polyethelene Gycol 4 Required Blood Pressure Increased Liters Generic PS ORAL 1 1/3 ORAL Intervention to Chills Prevent Permanent Eye Haemorrhage Impairment/Damage Injury Muscle Spasms Shock Tremor Date:05/20/02ISR Number: 3919602-1Report Type:Expedited (15-DaCompany Report #020010 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Other Fleet Enemas PS RECTAL 3 WEEK ANAL Renal Tubular Necrosis Golytely SS 1 L L HOUR NG Lactulose SS ORAL 4 TBSP DAY PO Miralax SS ORAL 34 GRAMS DAY PO Date:06/03/02ISR Number: 3927281-2Report Type:Direct Company Report #CTU 169412 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Miralax PS ONE CAPFU DAILY Phisohex SS 18-Apr-2007 11:25 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Other Macrogol (Dose Unknown), Unknown (Macrogol) PS ORAL 3 SACHETS IN 12 HOURS ORAL 1 DAY Date:09/16/02ISR Number: 3976459-0Report Type:Expedited (15-DaCompany Report #020020 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Consumer Golytely PS ORAL 5 LITERS; PO Miralax C Laculose C Zantac C Metoclopramise C Singulaire C Albuterol C Fleet'S Enema C Primary suspect was macrogol.... ......... ... Date:12/10/02ISR Number: 4025256-9Report Type:Expedited (15-DaCompany Report #863#3#2002- 00001(1) Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Idrolax (Macrogol) PS ORAL (EVERY DAY) Electrolyte Imbalance Chloral Hydrate C Sudden Death Risperidone C Cyamemazine C Clorazepam (Clorazepate Dipotassium) C Nicotinamide C Minidril (Ethinylestradiol, Levonorgestrel) C Maalox (Aluminium Hydroxide Gel, Magnesium Hydroxide) C Paracetamol C Date:12/31/02ISR Number: 4037925-5Report Type:Expedited (15-DaCompany Report #003#4#2002- 00049 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Macrogol (Dose Feeling Hot Health Unknown) PS ORAL 1 IN 4 HR. 1 DAY Tremor Professional Vomiting Other Date:01/17/03ISR Number: 4044591-1Report Type:Expedited (15-DaCompany Report #863#3#2003- 00001(0) Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Other Idrolax(Macrogol) PS 1/2 SACHET 1 DAY Initial or Prolonged Serum Sickness Vasculitis Date:03/12/03ISR Number: 4072212-0Report Type:Direct Company Report #USP 55576 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecaloma Peg 3350 (Peg Intestinal Obstruction Electrolyte Medication Error Solution) PS SOLUTION Pyrexia Lactulose SS SYRUP Renal Tubular Necrosis Miralex (Polyethylene Glycol) SS Braintree Date:04/01/03ISR Number: 4085511-3Report Type:Expedited (15-DaCompany Report #863#8#2003- 00006(1) Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Large Intestinal Literature Idrolax (Macrogol) PS ORAL ONCE ORAL Initial or Prolonged Haemorrhage Prednisone Other Medication Error (Prednisone) C Date:04/01/03ISR Number: 4085512-5Report Type:Expedited (15-DaCompany Report #863#1#2003- 00004 (2) Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Idrolax (Macrogol) PS ORAL 1 SACHET ORAL 1 DAY Initial or Prolonged Professional Shock Haemorrhagic Salofalk Date:04/03/03ISR Number: 4087155-6Report Type:Direct Company Report #CTU 190079 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Golytely PS ORAL 5 LITERS PO Renal Failure Miralax C Laculose C Zantac C Metoclopramise C Singulaire C Albuterol C Fleet'S Enema C (Aminosalicylic Date:04/03/03ISR Number: 4087156-8Report Type:Direct Company Report #CTU 190078 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Fleet Enemas PS RECTAL 3 WEEK ANAL Renal Failure Golytely SS 1 L L HOUR NG Renal Tubular Necrosis Lactulose SS ORAL 4 TBSP DAY PO Miralax SS ORAL 34 GRAMS DAY PO Acid) C Date:06/13/03ISR Number: 4128771-2Report Type:Direct Company Report #CTU 195765 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petechiae Polyethylene Glycol (Nulytely) PS NASAL 500ML PER Entizol Date:07/23/03ISR Number: 4152309-7Report Type:Direct Company Report #CTU 198468 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Peg-Asparginase 1550 Initial or Prolonged Units PS INTRAVENOUS X1 IM (Metronidazole) C Date:08/13/03ISR Number: 4169354-8Report Type:Expedited (15-DaCompany Report #030023 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Miralax PS ORAL 17 GRAMS Crying VARIED PO Diarrhoea Faecal Incontinence Irritability Lethargy Entcort Enema Date:08/18/03ISR Number: 4172197-2Report Type:Expedited (15-DaCompany Report #002#2#2003- 00417 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Consumer Colyte-Flavored- For- Erythema Oral-Solution Feeling Cold (Polyethylene Glycol Shock 3350) PS ORAL 1 ONCE, ORAL Tremor Urticaria (Budesonide) C Date:12/23/03ISR Number: 4258401-0Report Type:Expedited (15-DaCompany Report #030038 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Golytely PS INTRAVENOUS 12 CC IV Initial or Prolonged Urticaria Professional Date:04/15/04ISR Number: 4341635-4Report Type:Expedited (15-DaCompany Report #040014 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphthous Stomatitis Consumer Miralax PS ORAL 8.5 GRAMS ONCE DAY PO 3 WK Date:04/15/04ISR Number: 4341641-XReport Type:Expedited (15-DaCompany Report #040013 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Other Golytely PS 4 LITERS NG Intestinal Obstruction Oxybutin C Megacolon Date:05/12/04ISR Number: 4359315-8Report Type:Expedited (15-DaCompany Report #040019 Age:9.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Consumer Miralax PS ORAL 8.5 GRAMS Headache DAILY PO Muscle Spasms Antibiotics (Strep Tic Throat & Ear Vision Blurred Infection) C Date:07/27/04ISR Number: 4412918-4Report Type:Expedited (15-DaCompany Report #040041 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Miralax PS ORAL 17 GRAMS Drug Exposure Via Breast DAILY PO Milk Date:11/09/04ISR Number: 4498051-4Report Type:Direct Company Report #CTU 231554 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Miralax PS ORAL 17G DAY Anxiety ORAL There is also a MSDS (Material Safety Data Sheet) on Polyethylene glycol 3350 http://health.groups.yahoo.com/group/miralax/files/ Polyethylene glycol, which is common in cosmetics is contaminated with the exceedingly toxic dioxin. http://www.nutrition4health.org/NOHAnews/NNW97BrCanPrev.htm Ethylene glycol toxicity http://www.atsdr.cdc.gov/csem/egpg/physiologic_effects.html Do not dispose in sewer systems: http://www.jtbaker.com/msds/englishhtml/p5029.htm Some companies use polyethylene glycol and Isooctylphenyl for various reasons when producing the subvirion. Such chemicals cannot produce health. Polyethylene Glycol is a relative of ethylene glycol (antifreeze) which is often used to poison dogs and other predators of sheep. The body has a very difficult time expelling it because it is resistant to biodegradation. Isocctylphenyl ether is a compound of ether and has anesthetic properties. Isooctylphenyl ether is a teratogen, causing abnormal prenatal development. It also induces testicular atrophy in animals, and possibly in people. http://www.nvo.com/truthinhealth/smallpoxdrvetrano/ Polyethylene glycol and polypropylene glycol are related synthetics. They are relatively safe in themselves, but may be contaminated with potentially carcinogenic 1,4-dioxane. http://www.thenakedtruthproject.org/product.details.php?product_id=84 Prevacid contains PEG The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium carbonate, methacrylic acid copolymer, starch, talc, sugar sphere, sucrose, polyethylene glycol, polysorbate 80, and titanium dioxide. Components of the gelatin capsule include gelatin, titanium dioxide, D & C Red No. 28, FD & C Blue No. 1, FD & C Green No. 3*, and FD & C Red No. 40 (inactive ingredients). http://www.rxlist.com/cgi/generic/lansop.htm Lorazepam, Adivan Overdosage/Toxicology Symptoms of overdose include confusion, coma, hypoactive reflexes, dyspnea, labored breathing. Note: Prolonged infusions have been associated with toxicity from propylene glycol and/or polyethylene glycol. Treatment for benzodiazepine overdose is supportive. Flumazenil has been shown to selectively block the binding of benzodiazepines to CNS receptors, resulting in a reversal of benzodiazepine-induced CNS depression but not respiratory depressionhttp://www.umm.edu/altmed/drugs/lorazepam-077600.htm Overuse may cause diarrhea, excess loss of body water (dehydration), and mineral imbalance (e.g., low sodium). http://www.webmd.com/drugs/drug-17118-Polyethylene+Glycol+3350+Oral.aspx?drugid=17118 & drugname=Polyethylene+Glycol+3350+Oral Bowel Preps, safety and effectiveness in children has not been established http://www.endonurse.com/articles/bowel_preps/586_281feat1.html http://en.wikipedia.org/wiki/Polyethylene_glycol PEGylation is the process of covalent attachment of poly(ethylene glycol) polymer chains to another molecule, normally a drug or therapeutic protein. PEGylation is routinely achieved by incubation of a reactive derivative of PEG with the target macromolecule. The covalent attachment of PEG to a drug or therapeutic protein can "mask" the agent from the host's immune system (reduced immunogenicity and antigenicity), increase the hydrodynamic size (size in solution) of the agent which prolongs its circulatory time by reducing renal clearance. PEGylation can also provide water solubility to hydrophobic drugs and proteins. http://en.wikipedia.org/wiki/PEGylation http://www.halflytely.com/prof/faqs/faqs.html If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-]. Do not take more or less of it or take it more often than prescribed by your doctor. http://www.consumerreports.org/health/drug-reports/polyethylene-glycol-electrolyte-solution-peg-es.htm Bisacodyl DOES HAVE POLYETHYLENE GLYCOL as an ingredient, therefore Dulcolax suppositories does contain PEG http://www.listingdrugs.com/drugs/Dulcolax.HTM 2008 Letter to the FDA This is my letter to the FDA, I would appreciate any comments or anything else you would like me to include or exclude..... ... February 25, 2008 Jeanie Ward Re: Petitioning the FDA for the "Safety and Effectiveness of Polyethylene Glycol 3350 for pediatric use" Dear Sirs, I am re-petitioning the FDA in regards to the safety and effectiveness of Polyethylene Glycol 3350 in pediatric use, there seems to be growing numbers of adverse side affects since they started administering, off label use of this medication to children. I petitioned the FDA in 2001 and the FDA replied that, "The FDA has been unable to reach a decision on my petition because it raises issues that require additional review and analysis by the Agency" We have created a website pertaining to this, titled, miralax@yahoogroups .com There are about 5000 posts, and 450 members, of parents concerned about the negative side affects that their children are experiencing. In 2000, I contacted MedWatch, and requested the (AERS) FOIA a Advers Reaction Reports, there were only 6 adverse reactions to Polyethylene Glycol 3350, since then, the numbers have climbed to over 600, including death and there are probably many more since then. Without recognition of this issue, the children are receiving no merit as to what has happened to them, regarding the harm that this medication has caused. I am requesting that the FDA launch a thorough investigation. Sincerely, Jeanie Ward Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 24, 2012 Report Share Posted February 24, 2012 I wrote this in 2008, we now have 1560 members and the numbers from the FDA increased to 1,966 and climbing----- Forwarded Message ----To: dreamjeanie@...Sent: Sun, October 12, 2008 7:14:07 AMSubject: Miralax letter If you look up the facts about Polyethylene glycol, the data shows how dangerous this chemical is, these are facts....................you have to understand, 8 years ago I suspected this happened to my dd, and I started investigating. Just like our Physicians say, "If there's truly a problem, it will happen again" I was right and here they are, in black and white, thousands of them, that rip my heart out. These poor children.................. There is more here, than meets the eye................ I told my husband 8 years ago that this is what I suspected and here they are, one after another, on a daily basis......................I've tried everything to give Miralax the benefit of the doubt and it shows up every time............. all the time................. everyday people write to this group and to the FDA complaing about the EXACT same symptoms I wrote to the FDA about in 2000................unlike what side affects are listed on the label. The protocol is clearly wrong................. I first contacted MedWatch and submitted the list of symptoms my dd was experiencing, then I asked for the FOIA reports, which took months to obtain and I only got back 6 people, that stated: medication error, etc. I re-submitted on a yearly basis for the next 8 years to see if anyone else was having this problem and the numbers kept climbing, now there's close to 1000 (FOIA) adverse events reports, many children have died, and many may have irreversible damage. Thanks to my petitioning the FDA, found my petition through the FDA website and called me from halfway across the US and we decided to put this group together so we could find more people, now there are 600 members on this group, and over 5000 posts. I petitioned the FDA twice, the first time, in 2001, they responded................It needs more research................the last being in March of 2008 and still haven't heard a response? It's absolutely disgusting that the Material Safety Data sheets on this chemical states "Not to ingest" or "dispose down our sewer systems" and it's combustable, but yet they've somehow had this approved for adults as a bowel prep? Then went a step further and decided to give to children................as little as months old? Thank you for sharing all your testimonies so we can better understand what this medication is doing to the people who've ingested it, especially our children. If you feel you've had an adverse reaction to Miralax, please contact MedWatch to heighten their awareness...........at 1-800-FDA-1088, ask for Konginstien. He's the one who taught me how to obtain everything I've found.................. It will take many people to make a difference and you have to understand that unless we are heard, they will never do anything about this situation, and many more children will be harmed. Once a medication is approved, they have to go through many steps like only changing the label side affects before pulling a medication and all the legalities and sequence of events that have to happen first, so by us submitting to them now, will at least get the ball rolling. Below are the FDA adverse events I've recovered from the FDA......................They can't hear us unless we speak.................we need to create an Amber alert line for medications, not a slow moving FDA....................too many people are being harmed by their slow, out of date, so called.................system!!! My heart goes out to all the families, especially the children, that have been harmed by this chemical and the doctors that are so willing to hand it out. 8 years ago when we put this group together I knew I would dread having to hear your stories, or another harmed child, and what a price for a parent to have to pay, just to prove to ourselves and our families that this indeed happened, on top of having to deal with the heart ache of what happened to your own child. I hope to find away to bring this to their attention, so they can stop harming these children and give the children that have been harmed some merit.................we all need to understand the facts about this medication and how this medication works and what happened here............... to better understand what happened to our children and what to expect for their futures. Jeanie this link has an article called "Fatal Disnatremia Caused By Elective Colonoscopy", it was written in the BMJ (British Medical Journal) which is about 3 people who received an elective colonoscopy and 2 out of the 3 patients died after ingesting PEG electrolyte solution It also has the (FOIA) Freedom of Information Act FDA adverse reactions from 1997 to present.....................containing 869 reports, and many children have died from this medication, some will have irreversible affects.................below are just a few children on them........................ Date:08/03/98ISR Number: 3111591-5Report Type:Direct Company Report # Age:4.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anion Gap Increased Golytely PS Braintree Life-Threatening Brain Oedema Laboratories Inc 2400CC PER NG Other Gastrointestinal Disorder TUBE OVER 12 Hyponatraemia HOURS Metabolic Acidosis Fentanyl C Neuropathy Peripheral Ondansetron C Date:08/23/99ISR Number: 3332612-0Report Type:Expedited (15-DaCompany Report #002#1#1999- 00294 Age:16 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Colyte-For-Oral- Solu Initial or Prolonged Medication Error Professional tion (Sodium Respiratory Disorder Bicarbonate, Potassium Chloride, Sodium Chloride, PS ORAL 4 LIT, 1 IN 1 D, ORAL Sulfamethoxazole/ Tri methoprim C Date:08/23/00ISR Number: 3556117-7Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Golytely PS 150 CC/HR PER Intervention to Blood Creatinine G-TUBE Prevent Permanent Increased Impairment/Damage Blood Urea Increased Hypotension Sluggishness Tachycardia Wound Secretion Date:10/19/00ISR Number: 3598396-6Report Type:Direct Company Report # Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Miralax Mfd By Initial or Prolonged Abnormal Behaviour Braintree Labs PS Braintree Labs SEE ITEM B5 11 DAY Antisocial Behaviour Bipolar I Disorder Convulsion Decreased Appetite Depressed Mood Disturbance In Attention Fear Feeling Cold Frequent Bowel Movements Insomnia Movement Disorder Neurological Symptom Night Sweats Obsessive-Compulsiv e Disorder Paranoia Speech Disorder Staring Throat Tightness Tremor Date:11/28/00ISR Number: 3622985-3Report Type:Periodic Company Report #000017 Age:26 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Miralax PS Braintree Laboratories Inc ORAL 8.5 GRAMS QD Date:01/25/01ISR Number: 3654131-4Report Type:Direct Company Report # Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Miralax PS ORAL 17 GRAMS ORAL Bactrim C Date:10/04/01ISR Number: 3805237-8Report Type:Expedited (15-DaCompany Report #002#4#1998- 00152(1) Age:9 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Iatrogenic Injury Health Colyte-For-Oral- Solu Hospitalization - Lung Disorder Professional tion (Polyethylene Initial or Prolonged Medication Error Other Glycol 3350) PS NASAL ONE TIME Disability Pulmonary Fibrosis DOSE, NASAL 16 HR Pulmonary Function Test Decreased Date:10/11/01ISR Number: 3808143-8Report Type:Expedited (15-DaCompany Report #002#1#2001- 00114(1) Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Colyte-For-Oral- Solu Hospitalization - Atelectasis Professional tion (Polyethylene Initial or Prolonged Implant Site Reaction Glycol 3350) PS 600ML, ONCE, Lung Infiltration OTHER Date:10/30/01ISR Number: 3817675-8Report Type:Expedited (15-DaCompany Report #002#1#2001- 00114 (2) Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Colyte-For-Oral- Solu Hospitalization - Atelectasis Professional tion (Polyethylene Initial or Prolonged Lung Infiltration Glycol 3350) PS 600 ML, ONCE, Pco2 Increased OTHER Date:02/27/02ISR Number: 3874820-6Report Type:Direct Company Report #CTU 162452 Age:3 YR Gender:Male I/FU:I Outcome PT Other Abnormal Behaviour Abnormal Faeces Aggression Balance Disorder Constipation Crying Dysarthria Emotional Disorder Euphoric Mood Feeling Hot Hyperhidrosis Inappropriate Affect Motor Dysfunction Movement Disorder Obsessive Thoughts Paraesthesia Paranoia 18-Apr-2007 11:25 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychomotor Hyperactivity Rash Maculo-Papular Screaming Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Miralax Peg 3350 Sleep Disorder Braintree Speech Disorder Laboratories PS Braintree Tic Laboratories ORAL 17GRAMS PER DAY ORAL Colyte C Date:03/05/02ISR Number: 3879778-1Report Type:Direct Company Report #CTU 162783 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Miralax Mfd By Initial or Prolonged Electrolyte Imbalance Braintree Labs PS Braintree Labs 11 DAY Pain Paranoia Tic Tooth Disorder Tremor Date:03/28/02ISR Number: 3892204-1Report Type:Expedited (15-DaCompany Report #020006 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Golytely PS ORAL 4 LITERS PO Initial or Prolonged Asthenia Coma Haematochezia Mallory-Weiss Syndrome Mouth Haemorrhage Nausea Rectal Haemorrhage Syncope Vomiting Date:04/26/02ISR Number: 3907546-0Report Type:Direct Company Report #CTU 166738 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Polyethelene Gycol 4 Required Blood Pressure Increased Liters Generic PS ORAL 1 1/3 ORAL Intervention to Chills Prevent Permanent Eye Haemorrhage Impairment/Damage Injury Muscle Spasms Shock Tremor Date:05/20/02ISR Number: 3919602-1Report Type:Expedited (15-DaCompany Report #020010 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Other Fleet Enemas PS RECTAL 3 WEEK ANAL Renal Tubular Necrosis Golytely SS 1 L L HOUR NG Lactulose SS ORAL 4 TBSP DAY PO Miralax SS ORAL 34 GRAMS DAY PO Date:06/03/02ISR Number: 3927281-2Report Type:Direct Company Report #CTU 169412 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Miralax PS ONE CAPFU DAILY Phisohex SS 18-Apr-2007 11:25 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Other Macrogol (Dose Unknown), Unknown (Macrogol) PS ORAL 3 SACHETS IN 12 HOURS ORAL 1 DAY Date:09/16/02ISR Number: 3976459-0Report Type:Expedited (15-DaCompany Report #020020 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Consumer Golytely PS ORAL 5 LITERS; PO Miralax C Laculose C Zantac C Metoclopramise C Singulaire C Albuterol C Fleet'S Enema C Primary suspect was macrogol.... ......... ... Date:12/10/02ISR Number: 4025256-9Report Type:Expedited (15-DaCompany Report #863#3#2002- 00001(1) Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Idrolax (Macrogol) PS ORAL (EVERY DAY) Electrolyte Imbalance Chloral Hydrate C Sudden Death Risperidone C Cyamemazine C Clorazepam (Clorazepate Dipotassium) C Nicotinamide C Minidril (Ethinylestradiol, Levonorgestrel) C Maalox (Aluminium Hydroxide Gel, Magnesium Hydroxide) C Paracetamol C Date:12/31/02ISR Number: 4037925-5Report Type:Expedited (15-DaCompany Report #003#4#2002- 00049 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Macrogol (Dose Feeling Hot Health Unknown) PS ORAL 1 IN 4 HR. 1 DAY Tremor Professional Vomiting Other Date:01/17/03ISR Number: 4044591-1Report Type:Expedited (15-DaCompany Report #863#3#2003- 00001(0) Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Other Idrolax(Macrogol) PS 1/2 SACHET 1 DAY Initial or Prolonged Serum Sickness Vasculitis Date:03/12/03ISR Number: 4072212-0Report Type:Direct Company Report #USP 55576 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecaloma Peg 3350 (Peg Intestinal Obstruction Electrolyte Medication Error Solution) PS SOLUTION Pyrexia Lactulose SS SYRUP Renal Tubular Necrosis Miralex (Polyethylene Glycol) SS Braintree Date:04/01/03ISR Number: 4085511-3Report Type:Expedited (15-DaCompany Report #863#8#2003- 00006(1) Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Large Intestinal Literature Idrolax (Macrogol) PS ORAL ONCE ORAL Initial or Prolonged Haemorrhage Prednisone Other Medication Error (Prednisone) C Date:04/01/03ISR Number: 4085512-5Report Type:Expedited (15-DaCompany Report #863#1#2003- 00004 (2) Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Idrolax (Macrogol) PS ORAL 1 SACHET ORAL 1 DAY Initial or Prolonged Professional Shock Haemorrhagic Salofalk Date:04/03/03ISR Number: 4087155-6Report Type:Direct Company Report #CTU 190079 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Golytely PS ORAL 5 LITERS PO Renal Failure Miralax C Laculose C Zantac C Metoclopramise C Singulaire C Albuterol C Fleet'S Enema C (Aminosalicylic Date:04/03/03ISR Number: 4087156-8Report Type:Direct Company Report #CTU 190078 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Fleet Enemas PS RECTAL 3 WEEK ANAL Renal Failure Golytely SS 1 L L HOUR NG Renal Tubular Necrosis Lactulose SS ORAL 4 TBSP DAY PO Miralax SS ORAL 34 GRAMS DAY PO Acid) C Date:06/13/03ISR Number: 4128771-2Report Type:Direct Company Report #CTU 195765 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petechiae Polyethylene Glycol (Nulytely) PS NASAL 500ML PER Entizol Date:07/23/03ISR Number: 4152309-7Report Type:Direct Company Report #CTU 198468 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Peg-Asparginase 1550 Initial or Prolonged Units PS INTRAVENOUS X1 IM (Metronidazole) C Date:08/13/03ISR Number: 4169354-8Report Type:Expedited (15-DaCompany Report #030023 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Miralax PS ORAL 17 GRAMS Crying VARIED PO Diarrhoea Faecal Incontinence Irritability Lethargy Entcort Enema Date:08/18/03ISR Number: 4172197-2Report Type:Expedited (15-DaCompany Report #002#2#2003- 00417 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Consumer Colyte-Flavored- For- Erythema Oral-Solution Feeling Cold (Polyethylene Glycol Shock 3350) PS ORAL 1 ONCE, ORAL Tremor Urticaria (Budesonide) C Date:12/23/03ISR Number: 4258401-0Report Type:Expedited (15-DaCompany Report #030038 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Golytely PS INTRAVENOUS 12 CC IV Initial or Prolonged Urticaria Professional Date:04/15/04ISR Number: 4341635-4Report Type:Expedited (15-DaCompany Report #040014 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphthous Stomatitis Consumer Miralax PS ORAL 8.5 GRAMS ONCE DAY PO 3 WK Date:04/15/04ISR Number: 4341641-XReport Type:Expedited (15-DaCompany Report #040013 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Other Golytely PS 4 LITERS NG Intestinal Obstruction Oxybutin C Megacolon Date:05/12/04ISR Number: 4359315-8Report Type:Expedited (15-DaCompany Report #040019 Age:9.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Consumer Miralax PS ORAL 8.5 GRAMS Headache DAILY PO Muscle Spasms Antibiotics (Strep Tic Throat & Ear Vision Blurred Infection) C Date:07/27/04ISR Number: 4412918-4Report Type:Expedited (15-DaCompany Report #040041 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Miralax PS ORAL 17 GRAMS Drug Exposure Via Breast DAILY PO Milk Date:11/09/04ISR Number: 4498051-4Report Type:Direct Company Report #CTU 231554 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Miralax PS ORAL 17G DAY Anxiety ORAL There is also a MSDS (Material Safety Data Sheet) on Polyethylene glycol 3350 http://health.groups.yahoo.com/group/miralax/files/ Polyethylene glycol, which is common in cosmetics is contaminated with the exceedingly toxic dioxin. http://www.nutrition4health.org/NOHAnews/NNW97BrCanPrev.htm Ethylene glycol toxicity http://www.atsdr.cdc.gov/csem/egpg/physiologic_effects.html Do not dispose in sewer systems: http://www.jtbaker.com/msds/englishhtml/p5029.htm Some companies use polyethylene glycol and Isooctylphenyl for various reasons when producing the subvirion. Such chemicals cannot produce health. Polyethylene Glycol is a relative of ethylene glycol (antifreeze) which is often used to poison dogs and other predators of sheep. The body has a very difficult time expelling it because it is resistant to biodegradation. Isocctylphenyl ether is a compound of ether and has anesthetic properties. Isooctylphenyl ether is a teratogen, causing abnormal prenatal development. It also induces testicular atrophy in animals, and possibly in people. http://www.nvo.com/truthinhealth/smallpoxdrvetrano/ Polyethylene glycol and polypropylene glycol are related synthetics. They are relatively safe in themselves, but may be contaminated with potentially carcinogenic 1,4-dioxane. http://www.thenakedtruthproject.org/product.details.php?product_id=84 Prevacid contains PEG The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium carbonate, methacrylic acid copolymer, starch, talc, sugar sphere, sucrose, polyethylene glycol, polysorbate 80, and titanium dioxide. Components of the gelatin capsule include gelatin, titanium dioxide, D & C Red No. 28, FD & C Blue No. 1, FD & C Green No. 3*, and FD & C Red No. 40 (inactive ingredients). http://www.rxlist.com/cgi/generic/lansop.htm Lorazepam, Adivan Overdosage/Toxicology Symptoms of overdose include confusion, coma, hypoactive reflexes, dyspnea, labored breathing. Note: Prolonged infusions have been associated with toxicity from propylene glycol and/or polyethylene glycol. Treatment for benzodiazepine overdose is supportive. Flumazenil has been shown to selectively block the binding of benzodiazepines to CNS receptors, resulting in a reversal of benzodiazepine-induced CNS depression but not respiratory depressionhttp://www.umm.edu/altmed/drugs/lorazepam-077600.htm Overuse may cause diarrhea, excess loss of body water (dehydration), and mineral imbalance (e.g., low sodium). http://www.webmd.com/drugs/drug-17118-Polyethylene+Glycol+3350+Oral.aspx?drugid=17118 & drugname=Polyethylene+Glycol+3350+Oral Bowel Preps, safety and effectiveness in children has not been established http://www.endonurse.com/articles/bowel_preps/586_281feat1.html http://en.wikipedia.org/wiki/Polyethylene_glycol PEGylation is the process of covalent attachment of poly(ethylene glycol) polymer chains to another molecule, normally a drug or therapeutic protein. PEGylation is routinely achieved by incubation of a reactive derivative of PEG with the target macromolecule. The covalent attachment of PEG to a drug or therapeutic protein can "mask" the agent from the host's immune system (reduced immunogenicity and antigenicity), increase the hydrodynamic size (size in solution) of the agent which prolongs its circulatory time by reducing renal clearance. PEGylation can also provide water solubility to hydrophobic drugs and proteins. http://en.wikipedia.org/wiki/PEGylation http://www.halflytely.com/prof/faqs/faqs.html If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-]. Do not take more or less of it or take it more often than prescribed by your doctor. http://www.consumerreports.org/health/drug-reports/polyethylene-glycol-electrolyte-solution-peg-es.htm Bisacodyl DOES HAVE POLYETHYLENE GLYCOL as an ingredient, therefore Dulcolax suppositories does contain PEG http://www.listingdrugs.com/drugs/Dulcolax.HTM 2008 Letter to the FDA This is my letter to the FDA, I would appreciate any comments or anything else you would like me to include or exclude..... ... February 25, 2008 Jeanie Ward Re: Petitioning the FDA for the "Safety and Effectiveness of Polyethylene Glycol 3350 for pediatric use" Dear Sirs, I am re-petitioning the FDA in regards to the safety and effectiveness of Polyethylene Glycol 3350 in pediatric use, there seems to be growing numbers of adverse side affects since they started administering, off label use of this medication to children. I petitioned the FDA in 2001 and the FDA replied that, "The FDA has been unable to reach a decision on my petition because it raises issues that require additional review and analysis by the Agency" We have created a website pertaining to this, titled, miralax@yahoogroups .com There are about 5000 posts, and 450 members, of parents concerned about the negative side affects that their children are experiencing. In 2000, I contacted MedWatch, and requested the (AERS) FOIA a Advers Reaction Reports, there were only 6 adverse reactions to Polyethylene Glycol 3350, since then, the numbers have climbed to over 600, including death and there are probably many more since then. Without recognition of this issue, the children are receiving no merit as to what has happened to them, regarding the harm that this medication has caused. I am requesting that the FDA launch a thorough investigation. Sincerely, Jeanie Ward Quote Link to comment Share on other sites More sharing options...
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