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DrRussMD
DrRussMD, Board Certified Physician
Category: Eye
Satisfied Customers: 64627
Experience:  Internal Medicine--practice all of internal medicine, all ages, family, health, prevention, complementary medicine, etc.
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I am looking for email address for the FDA to send my whole

Customer Question

I am looking for email address for the FDA to send my whole medical background outline to FDA. I am a person with high sensitivity to medicines, and allergic reactions. I was recently hospitalized (3/30-3/29) and was diagnosed with seizures and put on Levetiracetam and Vimpat, both at the same time, for seizures (no previous seizures), and while in the hospital I developed red spots all over my body (not in clusters, but sporadic) and terrible itching at the red spots. Hospital added Benadryl for itching. As of today I have a severe, scary eye issue. My optomotrist sent me immediately to eye surgeon, who diagnosed mini stroke in optic nerve in right eye. I could not see out of my right eye at all. I again called the doctor who prescribed the seizure medicine (4 times on 4/18 and no reply). When I got home from eye surgeon my son told me that the hospital had tested me for a stroke (3/20-3/21), and I didn’t have a stroke. The eye surgeon ordered blood work, and that came back fine, per eye surgeon. The only change in my recent life was the addition of the 2 seizure meds and that's why I suspected my eye condition might be from the 2 seizure meds.
Since the doctor, Dr. Munson, who prescribed the seizure medicines still hadn’t called me back by 4/21, I called the pharmacist who said to call the drug manufacturers for a more complete list of drug interactions and side effects. AND INFORMATION I GOT !
It seems Dr Munson who prescribed the Levetiracetam, started me on the highest dosage allowed (3000mg/da, anything above that is not allowed) rather than the gradual increase recommended by the manufacturer. Keppra manufacturer also had a list of drugs tested for interaction. And they are also the manufacturer for Vimpat. And according to UBC (my case # ***** US16-004280) she said Vimpat (I am on a low dosage according to manufacturer) but Vimpat was not on the list as tested against Mepron (a long term antibiotic I am currently on as precautionary because of PCP pneumonia I developed after 2 Chemo treatments for CNS Lymphoma of the Brain in Jan & Feb, 2015. I was hospitalized (the end of February, 2015) because of fever and shortness of breath, and in hospital I was put into an induced coma, because I was not responding to antibiotics (fungel test is normal with a # of 69 or lower, I was up to 3700 in hospital (no, 3700 is not a typo). Somehow on day 9, I woke up from the induced coma. I found out from my family that the doctors had prepared my family that I might not be making it, but I did.)
Anyway, the person I was talking to at Keppra manufacturer, sent me 50 pages from her computer to back up what she had told me over the phone) and she had also completed an intake form for their Safety Dept. That Safety Dept has since called me for additional information.
When I called the manufacturer for Levetiracetam, they were not as helpful. I asked about side effects, she read to me the same information that is on the patient information sheet from the pharmacy. I asked about interactions with Mepron and Vimpat. I was told if they are not on the list, there is no interaction. I asked, but were they tested. The response was, if they were not tested during the trials, they won’t be tested now. l
So my question to you (FDA), what are the requirements for drug companies to test other medicines for interactions? Especially for new drugs or generics coming out. (In my search online for phone numbers for manufacturers, there are a lot of lawsuits against Levetiracetam). Do they need to test all other prescribed drugs? It just seems that the patient information sheets are not complete if these new drugs or generics are not all inclusive, if drug manufacturers are not completely testing against all other drugs. And then the pharmacists can’t give consumers complete or accurate information for interactions or side effects either because not all information is available from the drug companies, so this whole system is just not complete? Right?
Who is responsible for testing for interactions, the brand name manufacturer and/or generic company. And if not all other drugs are not tested, the consumer needs to be made aware of this fact.
I won't stop until I get answers to my questions that make sense to me.
I have a more detailed outline of my medical circumstances that I want to get to FDA. I can't seem to attach it here as an attachment. And I have a CD of my hospital records for 3/20-3/29 for the seizure episode and possible allergic reaction that caused red spots and itching in hospital. Can you provide email addresses so I can forward my whole situation and questions to you. Do you want copy of hospital CD? Thank you.
Please reply. If you don't reply, next I will contact the CDC and then US Surgeon General.
Thank you in advance for your anticipated cooperation.
Linda Riggs(###) ###-####
email: ***@******.***
Submitted: 1 year ago.
Category: Eye
Expert:  DrRussMD replied 1 year ago.

Hi

They are not likely to accept that by email.

You can send it to them regular mall.

Or you can call them if you want a specific directors email, which they might or might not give you.

Here is that information.

http://www.fda.gov/AboutFDA/ContactFDA/default.htm

OK, so you might have more questions or want to give me more information: Please use reply to expert if you have further questions. When you are ready, please click a positive rating [hopefully excellent—that’s how we are paid, per rating]. If you forgot something, come back. I am here daily