FDA Should Listen to Patients

Tramadol can cause seizures. Can Tramadol also bring on epilepsy? My son has been taking Tramadol for about 2 yrs. for nerve pain in his feet. All of a sudden he started having seizures. After 3 he was diagonized with epilepsy. I feel sure the medication is the cause. No family history of seizures. How long will it take to get the medication out of his system?

I had a great deal of discomfort in my left foot, heel and arch. I saw a GP, Interist, Sports specialist, Neurologist, Podiatrist. All had given me procedures, from new shoes to injections to surgery (which was not done), exercises, inserts. Nothing worked. I started taking B-12 Sublingual 500 mcg twice daily. Result, overnight relief. 95% relief of my foot discomfort.

My husband was experiencing shortness of breath and a constant headache for a few days before he decided it was not going away and was bothering him enough for him to see his primary physician. Blood tests and a chest x-ray found nothing out of the ordinary. Still having symptoms on a Saturday he went to the ER. More bloodwork was done along with a cat scan. Still nothing. That week he had an appointment with his urologist. He also was told of the symptoms and was instructed to keep taking his medecine (Uroxatral) for his prostate. After reading your aritcle about side effects I decided to check up on this med. Side effects include headache and upper respitory infection symptoms. His urogolist mentioned nothing about the two as a possible connection.

Thanks for blogging about this. I never fill a prescription any more without googling "prescription name + side effects" and reading anecdotal info on side effects.

I took Uraxatrol for about 11 months, and it made me so drowsy I was falling asleep at work every day, and dozing while driving to and from work. My urologist tried to convince me it wasn't the drug. I changed doctors, got a new prescription for Flomax, and haven't been tired in over a month. Uroxatral is dangerous, and the "fatigue" side effect should not be as understated as they claim.

I am convinced that the artificial sweetener aspartame killed my daughter. Jenny had two brain tumor operations by the time she was 20. She recovered, and except for a tendency toward seizures, she was able to live a normal life.

After leaving home she started drinking Diet Pepsi, and drank it heavily for the rest of her life. For 28 years she had no new medical problems. But at age 48 she developed a third brain tumor and underwent surgery. Normal life became too difficult for her, and she came to live with me.

For a year and a half she functioned fairly well, and she continued to drink Diet Pepsi by the case. Then she had another tumor and another operation. She recovered, but was now a semi-invalid. Six months later another tumor flared, and this time nothing more could be done. She died a year ago last August.

Two days ago I learned about the long and sordid history of aspartame. There seems to be no doubt that aspartame causes brain tumors and other problems, but after 30 years the FDA has not taken it off the market.

I went through my pantry and threw out everything that contained aspartame. I avoid buying anything that says "diet" or "sugar free" and I read the ingredients labels on packaged goods. I recommend others do the same.

I read with great interest your clip today in the Port St. Lucie News (Scripps) on the problem with use of the generic phenytoin vs brand Dilantin. I have been taking Dilantin since 1974 after being diagnosed with idiopathic epilepsy. I periodically have my Dilantin level checked. In later years my prescriptions have been filled by mail through our insurance provider's contracted pharmacy. At one point, several years ago, I was sent a refill of phenytoin generic instead of Dilantin, which I took. The next time I had my Dilantin level checked it was way below the therapeutic level for the first time in 30 years! My neurologist has since then explicitly prescribed Dilantin Only - No Generic.

When taking new medications or interested in your current medications check out :www.adverse-drug-reaction.net
You can search all reported adverse drug events by drug name. I found this site very useful when my mother was taking Avandia.

From the lady who posted on August 31, 2007 about the B12 Sublingual for heel spurs. I have New Balance shoes to help with my feet, the costly ones but they are well worth it if you are willing to spend $140.00 on some shoes. I have had injections, inserts, therapy, ultrasound, no surgery, exercises, and Sonorex. Nothing worked until Sonorex came out, which is shockwave therapy. With Sonorex, after all those other treatments and therapy upon therapy, I will take Sonorex any time, but the thing of it is I have to go through conventional treatment before they let me do Sonorex treatments because of insurance.

But I had years of heel pain and Sonorex helped, totally took all the heel pain away in the space of about 6 months, and the pain has been gone for some years. Now I have put on some weight and the heel pain is back. So I tried what the lady said about B-12 Sublingual 500 mcg twice daily. I got overnight relief, but my heels still hurt somewhat, but not as bad.

I am going to ask my doctor for the Ketoprofen gel that I have read in some of the posts to see if it takes out the remaining pain. I gave my custodian at my school some B12 Sublingual and it helped her heel spurs too. Thanks for sending in the helpful info and to the Graedons, I have tried many things from out of their book and have found some exciting and wonderful remedies that really do work.

I have to ask if anyone has had an issue with B-12 and sodas...

I was told I had a B-12 problem, and they told me to cut out the Pepsi. I did, and months later my B-12 was back on track; now I barely need the pills anymore.

However, recently I started drinking it again, and guess what, not only is the B-12 problem back, but now I have a major anemia issue...

Just wanted to know if others have had any of the same issues with Pepsi or Coke products. They say they are safe, but if they are depleting your body of essential vitamins, how safe are they ? I cannot say for sure this is the case, but I would like to know if others have had similar issues, or have noticed a relationship between these two....

Thank you...
Joannie

To Joanie: I find that after I have consumed too much diet soda (I mostly don't drink it, but I have my moments), I do feel very sluggish, and more than once I have been turned away from giving blood due to mild anemia. While I cannot say for sure that the soda is the cause, I certainly try to not drink it. Now, if I could get off the coffee.....

The FDA and Its Damaging Lack of Citizen Protection

The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of these funds the FDA receives is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this element of thier relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation as well as monitoring of the pharmaceutical company. It appears that the FDA's priorities have changed, and the safety of public health is now compromised. Yet the FDA continues to suggest behavior and actions demonstrated by this association that is clearly reciprocal, and void of the consequences of public health.

The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, never admit guilt as part of such settlements.
This FDA protocol that is now being considered, called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others.

Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue accurately is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest is such training. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation appears to be of most benefit for drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.

However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves. And the health of the public is that interest, and should be demanded by the FDA more than it appears to be presently.

“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung

Dan Abshear