| Comments for FDA General |
| Questions |
| 1. What improvements are needed to enhance communication about safety issues for drugs? What improvements are needed to communicate information about the efficacy of drugs? |
minor side effects are listed but major side effects are not or discussed until it is to late to do something about it. If death's have been linked to the use of medicine it should also be known. |
| 2. What are the strengths and weaknesses of the agency's current risk labeling approach? |
If people knew the true side effects related to medication it would indeed effect the pharmacutical business. But people have the right to know the real risks involved and whether they choose to purchase and use it, it would be at their own choosing. But they have every right to know minor as well as major and any deaths related. |
| 4. What other steps should FDA be taking to communicate risks and benefits? |
If a medication is not FDA approved for children it should be on the label and warning signs visible to warn them, instead of relying on health care professionals to discuss it with them. Not all health care professional's discuss what they should they discuss what they want. |
| 9. General Comments |
We had a precious 10 year old daughter die February 26th, 2001 from desipramine toxicity. We were not warned of the potentional dangers associated with the use of this medication. Nor were we told it was not FDA approved for the use of children. Our daughter was being treated for mild ADHD symptoms and was told desipramine was the best choice to use for her. Our daughter weighed 53 lbs. was 10 years old and was on 250mg daily taken in am. She had a grandmal seizure on February 26th, 2001 and never survived. There were absolutely no warning signs our daughter died within minutes and there was nothing we could do. Why would any physician risk the life of a 10 year old when there are medications that are FDA approved and safer. Things need to change we never had the right information associated with this medication and we feel that is very wrong. If we would have known the dangers with this medication our daughter never would have taken one dose of medication. People have the right to know if a medication is FDA approved or not and all risks involved from minor to major and if there has been any dangers or deaths related to the use of it. We need answers and we need help in understanding how a innocent 10 year olds life could be saved it more people would have been more careful and had better warning sign. She died of sudden death attributed to desipramine use and it need to be known so that it does not keep happening. We know it is to late to save our daughter but what has happened to us is not fair and should not be continueing |