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Tag "sumatriptan"

Triptans, such as Imitrex or sumatriptan and similar drugs are “designer” drugs which were developed to specifically treat migraine headaches. They are highly effective and, after more than 20 years on the market, proven safe. Four out of the seven drugs in this category (Imitrex, Maxalt, Zomig, Amerge) are available in a generic form, which significantly lowers their cost, which was one of the obstacles for their widespread use. So, it would appear that now there is no reason for doctors not to prescribe triptans to migraine sufferers.

In 1998, emergency department doctors gave more than half of the patients suffering from migraine headaches opioids (narcotics) to relieve pain and, according to a new study, 12 years later, this hasn’t changed.

Despite the fact that triptans are widely considered to be the best drugs for acute migraine, the use of these drugs in the emergency department has remained at 10%, according to a study led by Benjamin Friedman, an emergency medicine doctor at the Montefiore Medical Center in the Bronx.

In 1998, about 51% of patients presenting with migraine at the emergency department were treated with an injection of a narcotic and in 2010, narcotics were given to 53% of the patients.

Other than narcotics (opioids) emergency department doctors often give injections of an NSAID (non-steroidal anti-inflammatory drug) Toradol (ketorolac) or a nausea drug, such as Reglan (metoclopramide). These two drugs are more effective (especially if given together) and have fewer potential side effects than narcotics. They also do not cause addiction and rebound (medication overuse) headaches, which narcotics do.

Dr. Friedman and his colleagues looked at the national data for 2010 and found that there were 1.2 million visits to the emergency departments for the treatment of migraine. Migraine was the 5th most common reason people come to the emergency room.

They also discovered that people who were given a triptan in the emergency department had an average length of stay in the ER of 90 minutes, while those given Dilaudid (hydromorphone) – the most popular narcotic, stayed in the ER for an average of 178 minutes.

Opioids should be used only occasionally – when triptans, ketorolac, and metoclopramide are ineffective or are contraindicated. This should be the case in maybe 5% of these patients, according to Dr. Friedman

One possible reason why ER doctors do not follow recommended treatments and use narcotics instead, is that they do not recognize a severe headache as migraine and misdiagnose it as sinus, tension-type or just as a “severe headache”. Many doctors still believe that migraine has to be a one-sided headache, or a visual aura must precede a migraine, or that the pain has to be throbbing. It is well established that none of these features are required for the diagnosis of migraine.

Another possible reason for the widespread use of opioid drugs in the ER is that doctors are very accustomed to using them, while triptans may be unfamiliar and require thinking about potential contraindications, what dose to give, what side effects to expect, etc.

In summary, if you or someone you know has to go to an ER with a severe migraine, ask for injectable sumatriptan (which you should have at home to avoid such visits to the ER) or ketorolac.

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Tylenol (acetaminophen, or in Europe it is called paracetamol) is the go-to drug for pain, headaches, and fever during pregnancy. A new study just published in the journal JAMA Pediatrics indicates that this drug may not be as safe as previously thought.

Animal research has long suggested that acetaminophen is a so called hormone disruptor, a substance that changes the normal balance of hormones. It is a well-established fact that an abnormal hormonal exposures in pregnancy may influence fetal brain development.

Danish researchers decided to evaluate whether prenatal exposure to acetaminophen increases the risk for developing attention-deficit/hyperactivity disorder (ADHD) in children. They studied 64,322 live-born children and mothers enrolled in the Danish National Birth Cohort during 1996-2002.

The doctors used parental reports of behavioral problems in children 7 years of age using a specific questionnaire, retrieved diagnoses from the Danish National Hospital Registry or the Danish Psychiatric Central Registry, and identified ADHD prescriptions (mainly Ritalin) for children from the Danish Prescription Registry.

More than half of all mothers reported acetaminophen use while pregnant. Children whose mothers used acetaminophen during pregnancy were at about 1.3 times higher risk for receiving a hospital diagnosis of ADHD, use of ADHD medications, or having ADHD-like behaviors at age 7 years. Stronger associations were observed with use in more than 1 trimester during pregnancy and with higher frequency of intake of acetaminophen.

The researchers concluded that maternal acetaminophen use during pregnancy is associated with a higher risk for ADHD-like behaviors in children.

This presents a difficult problem in treating headaches and pain in pregnant women. Aspirin and other non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen can cause other problems in pregnancy and are particularly dangerous in the third trimester. In women with migraines, acetaminophen tends to be ineffective anyway, so these women should be given migraine-specific drugs, such as triptans (Imitrex or sumatriptan, Maxalt or rizatriptan, and other). They are much more effective than acetaminophen and the woman may need to take much less of these drugs than of acetaminophen. Triptans are also in category C in pregnancy, which means that we do not know how safe they are. Imitrex was introduced more than 20 years ago and we do not that it does not have any major risks for the fetus, but that does not mean that more subtle problems, such as ADHD are also not more common. Another headache drug that should be avoided in pregnancy is Fioricet. It is popular with some obstetricians because it has been on the market for 40 years. However, it contains not only acetaminophen, but also caffeine, which can make headaches worse, as well as a barbiturate drug butalbital, which can also have deleterious effect on the fetal brain.

Fortunately, two out of three women stop having migraines during pregnancy, especially in the second and third trimester. If they continue having headaches, treatment is directed at prevention. Regular aerobic exercise, getting enough sleep, regular meals, good hydration, avoiding caffeine, learning biofeedback, meditation or another form of relaxation, magnesium supplementation, are all safe and can be very effective. Acute treatments that do not involve drugs are often not very practical for a busy person. However, if the headache prevents normal functioning anyway, taking a hot bath with an ice pack on the head at the same time can help some women. Taking a nap, getting a massage, aromatherapy with peppermint and lavender essential oils are good options. For nausea, ginger and Sea Bands are sometimes very effective.

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Children with migraine headaches are usually given acetaminophen (Tylenol) or ibuprofen (Advil). A group of Italian doctors compared responses to these two drugs in kids with migraines who took a daily magnesium supplement to those who did not. Results of their study were published in the latest issue of the journal Headache. One hundred sixty children (80 boys and 80 girls) aged 5-16 years were enrolled and assigned to four groups to receive a treatment with acetaminophen or ibuprofen without or with magnesium. The dose of each drug was adjusted according to the child’s weight. Those children who were in the magnesium arm were given 400 mg of magnesium (the article does not mention which salt of magnesium was given – oxide, glycinate, citrate, or another). Migraine pain severity and monthly frequency were similar in the four groups before the start of the study. Both acetaminophen and ibuprofen produced a significant decrease in pain intensity, but not surprisingly, did not change the frequency of attacks. Magnesium intake induced a significant decrease in pain intensity in both acetaminophen- and ibuprofen-treated children and also significantly reduced the time to pain relief with acetaminophen but not ibuprofen. In both acetaminophen and ibuprofen groups, magnesium supplementation significantly reduced the attack frequency after 3 and 18 months of supplementation.

This study was not the most rigorous because it did not include a placebo group as the authors felt that placing children on a placebo would be unethical. However, it was rigorous in other respects and still provides useful information. The first conclusion is that taking magnesium reduces the frequency of migraines in children. The second is that taking magnesium significantly improves the efficacy of acetaminophen and ibuprofen.

The bottom line is that every child (and adult for that matter) should be taking a magnesium supplement. I have written extensively on the importance of magnesium because our research and that of others, including the above study, has consistently shown the benefits of magnesium. Unfortunately, after dozens of publications, hundreds of lectures, and recommendations from medical societies, many doctors still do not recommend magnesium to their migraine patients. Some are not familiar with the research, others dismiss any supplements out of hand, and yet others do not believe the studies because they think that magnesium is too simple and too cheap to be effective. Most doctors are trained to prescribe drugs and they feel that patients expect prescription drugs, so giving them a supplement will disappoint the patient and will reduce doctor’s standing in patients’ eyes. This is clearly not the case since many people prefer more natural approaches and because recommending a supplement does not mean that a prescription drug cannot be also given. In fact, magnesium improves not only the efficacy of acetaminophen and ibuprofen, but also prescription drugs such as sumatriptan (Imitrex).

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Intranasal sumatriptan powder seems to be a new and very promising way to deliver a migraine drug.  Sumatriptan (Imitrex) nasal spray has been available for many years, however it is not very effective or at least is not consistently effective.  The liquid tends to leak out of the nose, get swallowed, or just not get absorbed.  Nasal spray of Zomig (zolmitriptan) appears to be more effective, perhaps because of the smaller volume of the liquid and a finer spray particles.  The new product, OptiNose nasal powder seems to be even more effective.  It is a sophisticated device which does not allow for the powder to enter the lungs and deposits the medicine only in the nasal cavity.  In a study of 117 patients, 57% were pain-free and 80% had pain relief 2 hours after receiving 20 mg of sumatriptan powder, which was very significantly better than with placebo.  The nasal powder seems to be three times more effective than the nasal spray and almost as effective as an injection.  We hope that the FDA will approve this product in the near future.

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A new treatment for motion sickness in patients with migraines was reported by a group of doctors from Pittsburgh.  Giving migraine sufferers who are prone to motion sickness a migraine drug, rizatriptan (Maxalt) prevented motion sickness . There were 25 subjects in the study and 15 of them developed motion sickness after being rotated in the darkness. Of these 15 patients, 13 showed decreased motion sickness after being pretreated with rizatriptan. This was a small study and not all patients benefited, but this is an option that should be considered in patients who suffer from severe motion sickness.  It is likely that the effect is not specific to rizatriptan, but that sumatriptan (Imitrex), eletriptan (Relpax) and other triptans are also effective.  However, just like when treating migraine attacks, it is possible that some patients will respond better to one triptan and others to another.

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Severe migraines are often accompanied by nausea and vomiting, making oral medications ineffective.  Sumatriptan (Imitrex) and Zomig (zolmitriptan) are available in a nasal spray and Imitrex also as an injection (a needleless injection, Sumavel was launched recently).  Nasal spray is not well absorbed and does not work well for many (in my experience, Zomig spray is somewhat better than Imitrex).  Injections work fast, but are painful (even the needleless injection hurts) and expensive.  Another way to get medicine into the body is rectally.  Rectal suppositories are absorbed very quickly and more consistently than nasal sprays.  Europeans are much more receptive to this route of administration than the Americans.  A group of Italian researchers compared  the effect of a suppository containing 25 mg of sumatriptan with a 50 mg tablet.  The suppository was slightly more effective than the tablet.  Imitrex suppositories are not available, but so called compounding pharmacies can prepare a suppository of any medication, if doctor writes an order.  With Imitrex going generic, the price should be more affordable.

There are two other products in development (not yet available), which will bypass oral route – a sumatriptan skin patch and an inhaler of dihydroergotamine (Levadex).  The patch is somewhat large and may be awkward to use, while the inhaler is much more promising.  Inhaling a drug into the lungs provides very fast onset of action, faster than subcutaneous injection of Imitrex.  According to the published data the efficacy of Levadex is very good with few side effects.

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Some headaches, usually migraines, do not respond to the usual over-the-counter and even prescription headache medications.  Once it is clear that there is no serious underlying cause, such as an aneurysm, several injectable medications can be given in an emergency room (during office hours at the New York Headache Center we also give injections in the office). These medicines may include intravenous injections of: magnesium sulfate (which is not a medication, but a mineral), sumatriptan (Imitrex, which can be self-injected by patients at home), ketorolac (or it is also called Toradol, which is a drug in the aspirin family), dexamethasone (Decadron, a steroid drug, which can help pain of almost any type, but cannot be given for long periods of time), prochlorperazine (or Compazine, which is a nausea medication but can help pain as well), valproate sodium (Depacon), and several other drugs.

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Needle-free injection of sumatriptan (Imitrex) was tested for its ease of use and for its bioequivalence in a study led by Dr. Jan Brandes.  The new device that provides needle-free subcutaneous injections was easy to use and if injected into the thigh or abdomen (but not the upper arm) delivered the same amount of medicine as an injection with a needle.  Unfortunately, needle-free does not mean pain-free, so the injection still hurts.  This device, when it is approved by the FDA, may be useful for those patients who are afraid of needles.  Many migraine sufferers still do not know that injections of sumatriptan can be easily self-administered using a pen-like device that does contain a needle.  Many doctors do not offer this option because they do not think that patients will readily accept an injection or because they don’t realize how severe the migraines are.  I see many migraine sufferers who gladly take an injection over the tablet.  It is particularly effective for people who have severe nausea and vomiting with their migraine.  The speed of relief is another reason to take an injection – some patients wake up with a migraine and have to go to work or take care of their children and cannot wait for 1-2 hours before the tablet provides relief.  I have taken sumatriptan injection many times myself.  Usually the tablet works for me, but if before going to bed I have a headache from the wine I had with dinner, I will often opt for a shot.  The shot works within 10-15 minutes and allows me to fall asleep right after that, while a tablet may take an hour or longer.

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In addition to an injection, tablet and a nasal spray, sumatriptan is being tested in two other formulations.  No, it is not an inhaled form, which I just posted in my previous blog (dihydroergotamine inhaler), but through a skin patch and by a “lingual spray”, that is a spray into the mouth.  The skin patch may work fast and will deliver medicine through the skin, bypassing the stomach, which would be very useful for people who get very nauseous and have difficulty swallowing medications.   However, it is quite a large patch and will probably cost significantly more than a tablet, particularly in the generic form.  The second new formulation, a spray into the mouth, appears to partially absorb in the mouth and partially in the stomach, making it also work faster, although so far it looks to be only as effective as a 50 mg tablet.  The usual dose is 100 mg.  Also, hopefully the company that is developing this product has been able to mask the taste of sumatriptan.  Patients who have tried the nasal spray often complain of a very unpleasant taste, which can make nausea worse.

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Imitrex and Topamax are two migraine medications that recently lost their patent protection and became available in a generic form, under the names of sumatriptan and topiramate.  Many patients are concerned about the quality of generic products.  A recent study published in Neurology looked at 948 patients with epilepsy who were treated with generic Topamax (it is approved for the treatment of both migraines and epilepsy).  Compared to patients who used the branded Topamax, those on generic substitutions needed to have more of other medications, were admitted to the hospital more frequently and stayed in the hospital longer.  The risk of head injury or fracture (presumably due to seizures) was almost three times higher after the switch to a generic drug.

Clearly, migraine patients do not run the same risk as epilepsy patients of having a seizure or being admitted to the hospital, however a small number of patients can have worsening of their migraines.  The main reason is the legally permitted variation in the amount of medicine in each tablet.  Taking a higher dose of the generic drug can help.

The same applies to Imitrex – a small number of patients will find that the generic sumatriptan is slightly less effective.  The only, albeit significant, advantage of the generic drugs is cost savings.  At this point we have only one generic substitution for Imitrex and the price difference is only 20%, but in a few months more generics will appear and the price should drop significantly, which is a very welcome development for patients with frequent migraines.

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