why are we being scrutinized?

[Guest guest]

I would also like to ask? We are working with Physician's, Pharmacists's, and the FDA on this so why are we being scrutinized here?!!! To: "miralax " <miralax >Sent: Thu, June 14, 2012 6:52:28 AMSubject: Parents doing what they're suppose

to

It is not the parent's fault on how our system works with using drugs off label use in this CountryWe are doing exactly what the FDA wants us to do contacting MedWatch and petitioning them upon seeing adverse reactions (this is how they set up their system) We cannot help the laws that are set in place regarding drug companies that are allowed to market drugs stating that they don't cause "known symptoms"It is not fair that we must hold the burden and put up the money to petition the FDA when they allowed a drug without sufficient testing to be marketed to our children or to ourselvesIt is not good decision making that a company does not need third parties to test these drugs

upon getting a drug approved and their can be financial or political ties to these referencesIt's time that Physician's started listening to the Parents...............the adverse reactions speak for themselves, a data base they set up for us! The FDA stated it needs more review and analysis, so we decided to put it together for them! The FDA held a drug oversight board meeting in regards to this matter, so they do know there's a problem. The Drug Safety Oversight Board discussed reports of metabolic acidosis, metabolic acidosis with increased anion gap, and neuropsychiatric adverse events in children using polyethylene glycol (PEG) products. Metabolic acidosis is a disturbance in the body's acid-base balance and causes too much acid in the blood. In

some situations, metabolic acidosis can be a mild, chronic condition; however, it may lead to shock or death in severe cases. Neuropsychiatric adverse events may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.