Fibromyalgia Medications (The good the bad and the ugly) Part 6

I’d like to speak some more about some of the medications prescribed commonly to people with Fibromyalgia and Chronic Fatigue Syndrome.

Provigil – the name is Modanfinil is produced by Cephalon and is used in the United states for sleeping disorders such as sleep apnea and  excessive fatigue during the day. The way this medication works (mechanism) is unknown at this time and therefore the European Medicines Agency has recommended that this medication only be used for Narcolepsy, however that advice has not been followed in the U.S. Even though it works with histamines in the body, it shares many common traits with amphetamines. Provigil has a large potential for abuse as it acts on the reward parts of the brains (same has opiates, cocaine etc). It might not be as addictive as morphine, but the fact remains that it is still very addictive and has been seen to be abused by teens as a recreational drug.

In the Mid 2000’s it was used for ADHD (Attention Deficit Hyperactivity disorder), but was ultimately shown to be very unsafe for children and teens.

Cephalon was reprimanded in 2002 by the FDA because it’s promotional materials were found to be “false, lacking in fair balance, and otherwise misleading”.  Cephalon plead guilty to a criminal violation and paid several fines, including $50 and $425 million fines to the U.S. government in 2008 due to its  false and confusing marketing, especially making claims about it’s effectiveness that simply was not true.

Provigil is another of the fibromyalgia drugs prescribed off label meaning that it was never intended for Fibromyalgia. Under the U.S. food and Drug act, pharmaceutical companies are not allowed to market their medications for illnesses other than those specifically approved, however this law is not very well enforced.

Side Effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • white patches or sores inside your mouth or on your lips;
  • hallucinations, unusual thoughts or behavior;
  • depression, anxiety; or
  • chest pain, uneven heart beats.
  • headache, dizziness;
  • feeling nervous or agitated;
  • nausea, diarrhea;
  • trouble sleeping (insomnia); or
  • dry mouth.

This medication has an effect on the heart, liver and other organs so it is essential to let your doctor know if you do have heart or liver problems as this can be deadly. As with so many Fibro meds, it is absolutely essential to have a full blood and urine workup at least every 3 months minimum. If the Doctor is a bit lax about this or denies the necessity, change doctors and demand that the tests be done! I cannot emphasis this enough.

Halcion:  real name is Triazolam, it is used as a sedative and also used to treat very severe insomnia. It has been found that Halcion is not a good med for people with Fibromyalgia as it does not work well for those who wake up many times during the night (which is so typical of Fibro). It is manufactured by Upjohn and has been around since 1982. Halcion was withdrawn from the market in several countries because of concerns about serious side-effects (mostly psychological) associated with the drug.

Clinical trials which Upjohn had withheld from publishing showed a very unfavorable risk benefit ratio with 9.9% of patients dropping out of one triazolam study due to adverse effects . Another study not published by Upjohn found 12.2% of triazolam patients dropped out, again due to psychiatric adverse effects . A further study found that after only 3 weeks use of triazolam patients typically became markedly anxious.

The medical literature has shown that triazolam is much more likely than other similar meds to cause strange behavior and in some instances psychotic and or violent reactions. Therefore, it is a dangerous med, not recommended for any condition (as other meds exist without the extreme side effects) and a big moneymaker for Upjohn who tried to hide the negative studies and data from the FDA.

Side Effects:

  • weak or shallow breathing;
  • fast or pounding heartbeats;
  • confusion, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • thoughts of suicide or hurting yourself;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • problems with urination;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  • daytime drowsiness (or during hours when you are not normally sleeping);
  • amnesia or forgetfulness;
  • muscle weakness, lack of balance or coordination;
  • numbness, burning, pain, or tingly feeling;
  • headache, blurred vision, depressed mood;
  • feeling nervous, excited, or irritable;
  • nausea, vomiting, stomach discomfort; or
  • dry mouth, increased thirst.

Many can also have a sever allergic reaction to Halcion, which shows as hives, difficulty; breathing and swelling of the tongue. If this occurs, you must immediately call 911 or get to an emergency room.

Halcion is physically addicting and stopping the medication will cause the patient to undergo a withdrawal. As the half life (time the drug leaves the body) is so short, withdrawal symptoms can be felt even between the dosages of Halcion.

Lastly, you must be very very careful if you have liver and or kidney disease, problems with drug addiction, glaucoma, COPD , asthma, emphysema, bronchitis or other breathing problems. As with all strong meds, blood and urine tests are a must, at least every 3 months.

Sonata: real name Zaleplon, is manufactured by King Pharm, and is another medication used for insomnia. Though it has been banned in Canada due to it’s side effects, it certainly is more effective than Halcion for helping people get to sleep. another advantage is that the risk of addiction and dependence is very low. Stopping this medication causes slight or no withdrawal effects, another advantage. A special note is that senior citizens are more sensitive to this medication and should be used with care as it can cause a senior to lose balance and fall.

Zaleplon is abused on the street and it’s abuse can lead to hallucinations and amnesia. due to this last effect, users and abusers can lose track of taking the med and therefore, take it again, so care is necessary.

Side effects:

  • aggression, agitation, changes in behavior;
  • thoughts of hurting yourself; or
  • hallucinations (hearing or seeing things).
  • day-time drowsiness, dizziness, “hangover” feeling;
  • problems with memory or concentration;
  • numbness or tingling;
  • anxiety, depression, nervous feeling;
  • problems with vision;
  • headache;
  • nausea, stomach pain, loss of appetite, constipation;

  • dry mouth;
  • increased menstrual pain (cramps);
  • back pain, joint or muscle pain; or
  • mild skin rash.

Those with liver disease, breathing problems (asthma, emphysema, bronchitis etc) need to be especially careful with this medication. allergic side effects such as hives, breathing problems and selling of the tongue can also be a problem and if this occurs, 911 or a trip to the emergency room is essential.

Do not drink alcohol while you are taking this medication. It can increase some of the side effects of Sonata, including drowsiness. Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).Lastly, it is imperative that your doctor knows all the medications you are taking so have a list available, and once again, blood and urine testing is very important, at least 4 times per year at the minimum. Insist on it if necessary.

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