KEVEYIS (pronounced keh-VAY-iss) (dichlorphenamide) is a prescription drug used to treat (primary) hyperkalemic periodic paralysis, (primary) hypokalemic periodic paralysis, and other similar diseases.”
Severe allergic and other reactions have happened with sulfonamides (drugs such as KEVEYIS) and have sometimes been fatal. Stop taking KEVEYIS at the first sign of skin rash, swelling, difficulty breathing, or any other unexpected side effect or reaction, and call 911 right away.
Tell your healthcare provider if you take aspirin or if another healthcare provider instructs you to begin taking aspirin. High doses of aspirin should not be taken with KEVEYIS.
KEVEYIS can cause your body to lose potassium, which can lead to heart problems. Your healthcare provider will measure the potassium levels in your blood before you start treatment and at certain times during treatment.
Tell your healthcare provider about all other prescription and over-the-counter medicines you take, including supplements, as some medicines can interact with KEVEYIS.
While taking KEVEYIS, your body may produce too much acid or may not be able to remove acid from the body. Your healthcare provider may run tests on a regular basis to check for signs of acid buildup.
KEVEYIS may increase your risk of falling. Tell your healthcare provider right away if you experience a fall while taking KEVEYIS.
The risks of falls and acid buildup are greater in elderly patients.
It is not known whether KEVEYIS is safe or effective for people younger than 18 years of age.
What are the most common side effects with KEVEYIS?
The most common side effects are a feeling of numbness, tingling or burning (“pins and needles”) in the toes, feet, hands or fingers; trouble with memory or thinking; feeling confused; and unpleasant taste in the mouth.”
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 to report any information about the use of this drug.
- KEVEYIS [package insert]. Feasterville-Trevose, PA: Strongbridge Biopharma; 2019.
- Sansone VA, Burge J, McDermott MP, et al; for the Muscle Study Group. Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis. Neurology. 2016;86:1408-1416.
- Charles G, Zheng C, Lehmann-Horn F, Jurkat-Rott K, Levitt J. Characterization of hyperkalemic periodic paralysis: a survey of genetically diagnosed individuals. J Neurol. 2013;260:2606-2613
Narrative by JD Hunter
Most recently the term “primary” has been added to the front end of Periodic Paralysis. The addition of another generic word to an already generic group of words has no value and only serves to further the commercial interests of the manufacturer (IMHO).
I couldn’t find any solid evidence that KEVEYIS (renaming of Dichlorphenamide) is effective in the treatment of Periodic Paralysis (of any form). The warnings are stated on their website.
Opposites Are Not The Same
I find it contradictory that one drug is being prescribed to treat exact opposite symptoms (hyper and hypo) of the same condition. Ask yourself… if hyper means high and hypo means low then how could the same drug possibly lower potassium levels in one person and raise potassium levels in another person? The primary cause of muscle dysfunction in Periodic Paralysis is related to the cell wall (gating) structure (mechanism) itself. Other minerals such as calcium, sodium, magnesium play an equally important role in muscle function. If the cell gating mechanisms themselves are defective or abnormal (ion channelopathy) due to genetic mutations, it doesn’t matter the degree of potassium or other minerals floating around in the blood stream (serum). Flooding or starving the body with potassium or other minerals has serious effects on other body organs (kidneys, lungs, heart, etc.) as they struggle to maintain proper pH balances (adic-base balances) and has no effect in treating Periodic Paralysis causes or symptoms. It will only make things worse and has the potential to cause permanent damage and possibly death. The warnings and labels are required by law and should be taken very seriously.
Flooding a body with potassium in any form will only lead kidney damage, stones and promote metabolic acidosis. This and other similiar misunderstandings will be addressed in our Frequently Asked Quesitons section which should be available very soon. Starving the body of potassium will result in respiratory difficulties and promote metabolic alkalosis and possibly osteoporosis (among a host of other things). The safest and most effective way to treat Periodic Paralysis is to identify the triggers and eat a balanced diet following the 70-base/30-acid rule to maintain a proper pH balance.
“Acetazolamide, sold under the trade name Diamox among others, is a medication used to treat glaucoma, epilepsy, altitude sickness, periodic paralysis, idiopathic intracranial hypertension (raised brain pressure of unclear cause), and heart failure. It may be used long term for the treatment of open angle glaucoma and short term for acute angle closure glaucoma until surgery can be carried out. It is taken by mouth or injection into a vein.
Common side effects include numbness, ringing in the ears, loss of appetite, vomiting, and sleepiness. It is not recommended in those with significant kidney problems, liver problems, or who are allergic to sulfonamides. Acetazolamide is in the diuretic and carbonic anhydrase inhibitor families of medication. It works by decreasing the amount of hydrogen ions and bicarbonate in the body.
Acetazolamide came into medical use in 1952. It is on the World Health Organization’s List of Essential Medicines. Acetazolamide is available as a generic medication.”
It is used in the treatment of glaucoma, drug-induced edema, heart failure-induced edema, epilepsy and in reducing intraocular pressure after surgery. It has also been used in the treatment of altitude sickness, Ménière’s disease, increased intracranial pressure and neuromuscular disorders.
In epilepsy, the main use of acetazolamide is in menstrual-related epilepsy and as an add on to other treatments in refractory epilepsy. It has been demonstrated in drug trials to relieve symptoms associated with dural ectasia in individuals with Marfan’s Syndrome. A 2012 review and meta-analysis found that there was “limited supporting evidence” but that acetazolamide “may be considered” for the treatment of central (as opposed to obstructive) sleep apnea.
It has also been used to prevent methotrexate-induced kidney damage by alkalinalizing the urine, hence speeding up methotrexate excretion by increasing its solubility in urine. There is some evidence to support its use to prevent hemiplegic migraine.
The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development.
In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel.
Thursday, September 17, 2015 by Susan Q. Knittle-Hunter
“New” Drug For Periodic Paralysis $163.80 For One 50mg Tablet!!
I have written two blog articles in recent weeks about the drug Dichlorphenamide, also known as Keveyis, made by Sun Pharmaceuticals Industries Ltd (Taro Pharmaceutical). The first article was to announce a new drug, which had been approved by the FDA to treat Periodic Paralysis (PP). The second article was written after the facts were discovered about the new drug. Today, I find it necessary to write a third article since the cost for the drug has been announced and the stock market is showing gains for Sun Pharmaceuticals after the announcement.
I want to explain a few things before I continue, however. The Periodic Paralysis Network (PPN) was created to help individuals who have been diagnosed with Periodic Paralysis or those who are not yet diagnosed but have symptoms of Periodic Paralysis. Due to the nature of a mineral metabolic disorder, most drugs are harmful and even deadly for those with the varying forms of PP. The major way that the PPN has chosen to help others is to share natural methods to manage the symptoms and paralytic episodes. We have grown to be an organization to provide support, education, and advocacy to our members and attempt to bring awareness of PP to the world.
We are members of an international medical advocacy association working to provide safe and appropriate medical care, so as an advocacy group, we feel it is our duty to attempt to keep our members as safe as possible and to advocate for their medical rights. At least fifty percent of our members cannot take the “new” drug due to terrible short term and long term side effects. Due to the reasons above and for liability reasons, we have chosen to refrain from discussing drugs in our support group and opt to discuss the natural and common sense methods.
When the new drug announcement was disclosed, we wanted to be fair and hoped for the possibility of something “new” and different, so we were happy to discuss it. However, we found out it was the same as the other drug already being used, which causes harm to a portion of our members. At that time, we felt in necessary to warn our members of the facts…a mistake with drugs can kill some of us…so it is a serious issue. In both articles, to be fair, we mentioned that some of us do well on it and we are happy for those members, but regardless of that, nearly one half of those individuals who do get some relief from it, continue to develop side effects, both short term and long term.
When the outrageous cost was announced, as well as the benefit this would have for the Pharmaceutical Company involved, and because we are advocates for ALL individuals with Periodic Paralysis and the members of our forum, we felt it necessary to write about this. I, myself, cannot take it, so the cost does not directly affect me, but some individuals with Periodic Paralysis can and do want to take it and some rightfully, want to try it. We support these individuals but warn them to use caution.
Information has come to me today that indicates the pharmaceutical company is now saying that the drug will be available for everyone, even if he or she cannot afford it. I hope that is the case, we will see in the future if that is true or not.
For those who wish to take the drug but cannot afford it; and for those who need to know or would like to know about the individuals for which the drug was created and for the pharmaceutical company that has seen fit to charge $163.80 for one pill that could change the lives of some very ill individuals, if they could afford it; I have written the following:
(I have edited my original article. This following is the edited version…)
This drug has been touted as a new drug and the first drug approved by the US Food and Drug Administration (FDA) to treat a group of metabolic disorders known as the Periodic Paralyses. Until now, off-label drugs (drugs used for other purposes) had been used with some success for some of the individuals with this disabling and serious medical condition.
For the community of people who suffer the horrible effects of this disorder, also known as an ion channelopathy, this was big news…a new drug AND it is approved by the FDA! This brought rejoicing and hope to the more than (under-estimated) 5,000 individuals in the United States with various forms of Periodic Paralysis (PP).
This excitement was short-lived, however, for more than half of the individuals who are incapacitated from this cruel condition.
It turns out that Keveyis, also known as Dichlorphenamide, is not new at all. It is the same type of drug as the off-label drugs being used by some individuals. Some are having great success, but not without short and long term side effects. Dichlorphenamide is a carbonic anhydrase inhibitors (a diuretic) and it is sulfa-based. Some individuals with other forms of PP cannot use it without serious side effects. Some have nearly died from it and deaths have been reported from its use.
Another issue is, it is not new to Periodic Paralysis and has been used previously by patients with Periodic Paralysis for many years at a cost of about the same amount as a bottle of aspirin, but was pulled from the market while studies were done over several decades. Before that time some people had success with it, but others had terrible side effects from it.
During those years, many people with PP were involved in studies using the drug. Many of those individuals did well, but when the study was completed, the drug was no longer given to the patients. They had to go without any treatment or take the off-label drug that was not as effective.
So we have a “new” drug that is not “new” at all, which was taken away from individuals who really needed it and were doing well with it. Then we had twenty-three years of studies being done at which time people with PP were using it and feeling some relief from their horrible symptoms and episodes of paralysis and gradual permanent muscle weakness. After that, the drug was taken away and the patients were left to fend for themselves, with the promise that sometime in the future, the drug would be available for everyone!
The drug is touted as being a treatment for “periodic paralysis”…to mean all forms…this is misleading. There are many forms of Periodic Paralysis. This drug can only be used for a few forms, or genetic mutations of this condition. To the remainder of those with the “wrong” mutations and who cannot take it, there are serious side effects and possible death.
There are several forms of Periodic Paralysis and many genetic mutations for each form. The different types cause the paralytic episodes, muscle weakness and other symptoms in varying ways. Potassium shifts in the body abnormally either in low, high or within normal ranges caused by many triggers. This happens as follows depending on the various forms.
- Paralysis results from potassium moving from the blood into muscle cells in an abnormal way,
- Paralysis results from problems with the way the body controls sodium and potassium levels in cells.
- Paralysis results when the channel does not open properly and potassium cannot leave the cell.
- Paralysis results when potassium shifts within normal ranges.
- The sodium channels close much too slowly and the sodium, potassium, chloride and water continue to flow into the muscles.
- Or the normal pores in the muscle cell walls just do not work correctly.
Knowing this information, my question is as follows, “How can one drug possibly treat and correct all of these possible malfunctions?”
These realizations were very disappointing to many of us. We were hoping for more research and for possibly some new forms of treatment…not drugs, because most of us cannot take any form of drugs.
Then came the day with the announcement…The “new” drug is now available for use in the United States of America. The cost?????? $163.80 for one 50mg tablet!!! Most individuals need more than that a day, so for two tablets a day it is estimated that the cost will be $120,000.00 per year, for each person!!! Imagine a family with several people with the same condition? After all, it is an inherited disorder. Most insurance companies will not pay for this drug.
Most people who suffer from Periodic Paralysis are disabled and live on Social Security. This drug will never be available for them to use.
Many of those who wanted to try it were going to take a risk just to see if it might help, knowing the probable side effects. But now, this opportunity has been taken from her.
In the past year, I was contacted by three pharmaceutical representatives seeking information about and from individuals with Periodic Paralysis. I was told there was a “new” drug for Periodic Paralysis that was about to be released. They wanted the names of the members of our PPN Support Group so they could be interviewed about this ‘up and coming’ “new” drug.
I told each one that I could not give out the names of my members and that I wanted to know more about the drug before revealing such information. I did not want to give false hope to our members. I know that most drugs are harmful to us. I did an interview myself with the first team. I personally explained the facts to them about the issues with the use of drugs with a mineral metabolic disorder. I explained that most of us needed other things to help manage our symptoms.
We need potassium readers that cost $350.00 a piece and are not paid for by insurance. We need other medical devices to monitor our vital signs when in paralysis because during episodes of muscle weakness or paralysis, which may last many hours, there may be serious heart arrhythmia, fluctuating heart rate and blood pressure, choking, breathing issues and low oxygen levels. A patient may stop breathing or go into coronary or respiratory arrest or both and therefore, the patient must never be left alone during an episode and all vitals must be constantly monitored. I described the diet we must follow and how we need to avoid triggers, which can trigger the paralytic episodes. These include but are not limited to: most drugs including antibiotics, food fillers and dyes, pesticides, sugar, salt, gluten, stress, anesthesia, IV’s, stress (good and bad), exercise, exertion, carbohydrates and much more. I explained that, for those reasons, we need a special, natural and organic diet, which is very expensive.
I continued to explain that we have to pay for these things out of our own pockets because insurance does not cover them. I explained that if they really wanted to help us they could research ways to help us to get what we need and for insurance to pay for them. I discussed how most doctors, even the “specialists” know little about the condition. We need a way for all medical professionals to be trained properly about Periodic Paralysis for better recognition, diagnosis and treatment in a timely manner (my own diagnosis took over fifty years!) If they want to really help us, these are the things we need…not another drug we cannot take.
This team never did tell me about the drug or its name, so I did not pass along the information to the members of our Support Group since I had nothing to share.
The second representative never did get back with me after I asked him about the drug. He said he was not allowed to tell me about it, yet he wanted the list of names of all of the members of our support group.
The third representative approached me in a different manner and caught me off guard. She praised my writings on our blog and was terribly “moved” when she read my story. She wanted me to do an interview about the new drug and I told her all of the same information. She was allowed to tell me that at the end of the interview that the “new” drug was actually another carbonic anhydrase inhibitors and knew that it could not help me, or many of the others, from the information I had given to her. She seemed sincere and she assured me that they wanted to gain more information to know of other ways to help those of us who cannot take the “new” drug or any drug. I thought and hoped she was sincere. I now doubt it.
With a heavy heart, I would like to say to her and the pharmaceutical company, which she represents, for those individuals with Periodic Paralysis, who either want to take the drug, or at least try it, and for those of us who cannot take it:
ARE YOU KIDDING!!!!!!!! $163.80 FOR A 50mg TABLET!!!! MOST PEOPLE WILL NEED AT LEAST TWO PILLS PER DAY!!! THAT IS $120,000.00 FOR ONE YEAR FOR ONE PATIENT!!!! NO ONE WHO HAS PERIODIC PARALYSIS CAN AFFORD THAT AND IT IS UNLIKELY THAT INSURANCE WOULD PAY FOR IT!!!!!!!!!!!!!!! THIS IS UNCONSCIONABLE!!! THE PHARMACEUTICAL COMPANIES SHOULD NOT BE ABLE TO DO THIS TO THE SICKEST PEOPLE ON EARTH!!! WE ARE ALREADY DOWN!!!!! JUST KICK US SOME MORE!!!!!!!!
IF YOU REALLY WANT TO HELP US CREATE A DRUG OR A TREATMENT THAT CAN HELP ALL OF US, AND UNTIL THAT TIME BUY EACH FAMILY A POTASSIUM READER AND /OR AND OR AN ISTAT, AS WELL AS, ALL OF THE MEDICAL EQUIPMENT WE NEED FOR MONITORING DURING AN EPISODE, PAY FOR THE SPECIAL DIET WE MUST EAT, PROVIDE US WITH THE ADAPTIVE EQUIPMENT WE NEED, PAY FOR THE OXYGEN WE MUST USE WHEN OUR BREATHING BECOMES TOO SHALLOW DURING PARALYTIC EPISODES, PAY OUR MEDICAL BILLS AND COPAYS, AND MORE…YOU CAN ALSO PAY FOR TRAINING ALL OF THE DOCTORS AND MEDICAL PROFESSIONALS WHO DO NOT KNOW OR UNDERSTAND PERIODIC PARALYSIS.
ACCORDING TO THE STOCK MARKET REPORTS WE ARE RECEIVING, ABOUT SUN PHARMACEUTICAL INDUSTRIES LTD, THE INTRODUCTION OF THE NEW DRUG KEVEYIS AND THE AMOUNT THAT EACH PILL WILL COST HAS RAISED THE VALUE OF THE STOCK/COMPANY ON THE STOCK MARKET! THE HEADLINE FROM AN ARTICE TODAY SAYS:
“POSITIVE NEWS FLOW PROPELS SUN PHARM’
THAT MEANS THE CEO’S AND STOCK HOLDERS WILL HAVE SOME EXTRA MONEY THAT THEY CAN DONATE TO THE EXTREMELY ILL AND DISABLED INDIVIDUALS WITH PERIODIC PARALYSIS. AFTER ALL, THEY WILL BE MAKING IT OFF OF THEIR BACKS; THE BACKS OF SOME OF THE MOST ILL AND MISTREATED INDIVIDUALS ON THIS PLANET WITH A DRUG THAT MAKES MANY OF THEM WORSE, HAS HORRIBLE SHORT TERM AND LONG TERM SIDE EFFECTS AND CAN EVEN KILL THEM.
I hope it is true that Sun Pharmaceuticals Industries Ltd. is going to provide this drug to those who cannot afford, anything else is wrong…..
Links about the drug Keveyis and the pharmaceutical company:
Here is some more information about dichlorphenamide:
The following is information about dichlorphenamide (keveyis) from the pharmaceutical company, including some of the side effects:
Articles and information about issues related to acetazolamide and diamox.
Contraindications for oral diamox
More information about diamox:
Side effects for children:
I understand that in some cases it may be the best of two evils…a very tough decision…but you must be aware of the possibilities…
Acetazolamide and Kidney Stones