Showing posts with label Black Box Warning FDA Black Box. Show all posts
Showing posts with label Black Box Warning FDA Black Box. Show all posts

Friday, November 8, 2013

Was Sprycel Keeping My Peripheral Neuropathy at Bay?

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In April of 2010, a little more than three and a half years ago, I suffered extreme side effects from an antibiotic called Cipro, also known as Ciproflaxin. This antibiotic is in a class of antibiotics called floroquinolones; Levaquinn and Avelox are also in this class of antibiotic. Apparently in 2010 there were over 20 million prescriptions written for Cipro, and its’ popularity has increased.

Cipro was designed as a powerful, last drug of choice, antibiotic to be used in extreme bacterial infections that did not respond to prior treatment; it has become a first choice antibiotic for many, many physicians and dentists, despite its’ Black Box Warning status.

So, what’s the big deal? It’s an antibiotic, right? All antibiotics come with some risk and side effects, right? If you’re sick, you need an antibiotic, right? While all of these answers may be “yes” I will tell you what three doses of this antibiotic have done to me; they have apparently caused a permanent, peripheral neuropathy; with my feet being the hardest hit.

I suppose that I probably take in excess of 10,000 steps each and every day; imagine excruciating pain every time that you put weight on your foot; that is 10,000 jolts a day. And imagine that after you experience the jolt, your feet just throb in between each jolt. That is what Cipro did to my feet. I had/have many other issues as well, but my feet are my greatest challenge.

Fast forward eleven months from my second floxing; I was diagnosed with chronic myelogenous leukemia. During my initial treatment I received a chemotherapy drug called Cytarabine. Within days of receiving these chemo treatments, my foot pain began to subside; eventually it became almost non-existent. I began to be able to walk normally and I began to be able to use and bend my toes, my knees and my hips without pain. I was ecstatic! I had found a golden lining to having leukemia; my daily pain was much improved; I began to move, and dance like my old self. To me it was miraculous; to the doctors, they simply shrugged and said that they often heard that people’s RA and other peripheral neuropathy improved after chemotherapy.

I cannot tell you how happy and excited I have been without this daily pain. I was released from the hospital and began a daily medication called Sprycel. Sprycel is a drug used to treat CML. Apparently it also has kept my peripheral neuropathy at bay, because for two and a half years, my pain level has remained stable.


That is until I developed pleural effusion, a side effect of Sprycel, and had to stop my treatment for three weeks until the PE resolved. During this time, the pain in my feet has returned. It began slowly but has continued to progress; it is depressing and I swear I would go in and have a round of chemo if I knew that it would help. I am hoping and praying that by resuming my Sprycel treatment the pain will begin to subside once more, but I also wonder if the Sprycel was strong enough to hold the peripheral neuropathy at bay, but not strong enough to stop it. 

Something to ask at my next doctor's appointment....

Thursday, December 6, 2012

Here is the Floroquinolone FDA Black Box Warning!


FDA BLACK BOX

The Food and Drug Administration imposed the government's most urgent safety warning on Cipro, Levaquin, Avelox and many other flouroquinolone antibiotics. The FDA orders a prominent "black box" warning and the development of new literature for patients emphasizing the risks. The most prominent risk is tendon rupture causing long term disability, possibly permanent.

This is an important first step to ensuring these antibiotics are only used when the patient faces a potential fatal outcome, and only after the use of all other antibiotics have been ruled out. This is not due to the probability of risk, but rather severity.

To those who have been affected, prognosis is normally not good. There is no cure. Often repeat exposure through food and water cause a continual never ending cycle of symptoms. Many victims face the fact that their lives have been completely destroyed. Many face loss of job and income, some face breakup of the family. Some have even committed suicide because of the pain inflicted by these drugs.

Unfortunately, physicians currently give these prescriptions out like candy. To emphasize the ignorance of physicians, Cipro is often prescribed post-op for tendon repair surgery. The physician will often prescribe a drug known to cause tendon rupture as a preventive to infection after tendon repair surgery. There is an obvious neglect on the part of the physicians who simply do not known the potential dangers of the drugs they prescribe. So where is the breakdown of information? Unfortunately many physicians mistakenly rely on pharmaceutical drug reps to point out any potential side effects rather than investigating it themselves. Further implicating the physicians, they accept gifts from drug companies and in return will prescribe unnecessary and dangerous substances. Drug Reps, paid on commission, find themselves making more sales by not disclosing the dangers, or make light of potential side effects. Making the problem worse, the drug manufactures trivialize and distort the potential risks.

A pending U.S. Senate bill would require drug companies to report gifts to doctors of more than $25. New York State's legislature plans to hold hearings this year on the relationship between doctors and drug companies. One congressional critic has even compared the drug industry with the tobacco industry, and Senator John McCain has called drug makers the "bad guys."

Antibiotics known as flouroquinolones have been associated with some or all of the following adverse drug reactions:

Tendonitis, Tendon Rupture, Tendon, Ligament, Joint and Muscle Damage
Vision Damage, Hearing Loss, Taste Perversion
Peripheral Neuropathy (Tingling, burning sensation)
Insomnia, Nightmares, Anxiety Attacks, Depersonalization, Cognitive Disorders
Brain, Heart, Liver, Kidney, Pancreas, Blood and Endocrine Disorders
Severe Psychotic Reactions, Suicidal Thoughts or Actions
Gastrointestinal Damage

Compounding the problem, there are numerous drugs which should not be taken in combination with this class of antibiotics. There are increased risks of injury when they are taken in combination with corticosteroids (e.g.: Prednisone, Flovent, Nasarel, Azmacort, Advair Disku, Methylprednisolone Dospak, Elocon Cream, Desoximetasone Cream, and Sterapred) and when taken in combinations with non-steroidal anti-inflammatory drugs (NSAIDs) (e.g.: Motrin, Pamprin, Aleve, Advil, and Ibuprofen, among others). Physicians are frequently not aware of these contraindications and prescribe dangerous combinations of drugs which cause severe injuries to their patients. Physicians may also not be able to identify that their patient is suffering an adverse reaction and instruct them to continue to take more of the antibiotic resulting in very serious and perhaps preventable injuries.