Not surprisingly, none of the new migraine drugs have been tested in pregnant women. No new drug for any indication is ever tested for its safety in human pregnancy. They are always tested in pregnant animals, which helps weed out most drugs that are clearly dangerous. It takes decades to learn if a drug is safe. This happens through an accumulation of anecdotal reports and pregnancy registries that are usually run by drug manufacturers.

Erenumab (Aimovig) was the first CGRP monoclonal antibody to be approved for the preventive treatment of migraines four years ago. It was tested in pregnant monkeys who were given 50 times higher doses (by weight) than the FDA-approved dose for humans. Even though some of the medicine crossed the placenta into baby monkeys, they had no developmental problems.

In the current issue of Headache, University of Texas doctors published a report of a woman who continued to inject herself with erenumab throughout the duration of her pregnancy. She tried to stop the drug before planning to get pregnant but her severe migraines recurred. Her baby was born healthy and had normal development by the last evaluation at 6 months of age.

This case report is the first very small but important step in the process of evaluating the safety of erenumab in pregnancy.

In humans, the transfer of antibodies, which are large molecules, across the placenta is very limited before the 16th week of pregnancy and increases after the 22nd week. We still recommend stopping the drug about five months before a pregnancy is planned. If a woman, however, does get pregnant, intentionally or not, the risk of complications is low if erenumab is stopped within the first three months of pregnancy. This also applies to all other monoclonal antibodies in general and specifically other migraine drugs – galcanezumab (Emgality), fremanezumab (Ajovy ), and eptinezumab (Vyepti).

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Rimegepant (Nurtec ODT) was just approved by the European Medicines Agency for marketing in 27 EU countries as well as Iceland, Liechtenstein, and Norway. It was approved for both the acute treatment of migraine with or without aura, and prophylaxis (prevention) of episodic migraine in adults who have at least four migraine attacks per month. The drug will be sold under the name VYDURA.

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If you are “overusing” acute migraine medications, preventive migraine treatments still work very well. This was the conclusion of a study that was just published in the journal of the American Academy of Neurology, Neurology.

The concept of medication overuse headache (MOH) has remained controversial. The majority of headache specialists believe in its existence. And that is what it is, a belief. There are correlational studies showing that those who take acute migraine drugs tend to have them more often as time goes on. This obviously does not mean that the drug is responsible for the increase in frequency. It is more likely that people take drugs more often because their headaches have gotten worse. There is proof for the existence of MOH only for two drugs – caffeine and opioid (narcotic) pain drugs. Triptans and NSAIDs have no such proof and in my 30 years of experience, they rarely cause MOH.

The daily use of triptans is the topic of my most popular post in the 15 years of writing this blog. It received about 400 comments. Many people commented how relieved they are that taking triptans daily can be safe and effective. They often lament that they can’t get their doctors to prescribe a sufficient quantity of pills.

I am not suggesting that taking triptans daily is the first or second option. It is always better to try Botox and non-drug approaches. Taking a triptan daily, however, is probably safer than taking FRA-approved epilepsy drugs such as topiramate (Topamax) or divalproex (Depakote), or even an antidepressant.

The article in Neurology describes a large study with over 700 participants who were “overusing” acute migraine medications. Half of them were taken off these drugs and started on preventive therapies and the other half were given preventive therapies without stopping acute drugs. Both groups did equally well. This goes against the old dogma that preventive therapies will be ineffective if the daily abortive drugs are not stopped first. The most common preventive treatments in this study were topiramate, Botox, and amitriptyline (Elavil).

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Yesterday I saw a 48-year-old man who has been suffering from migraine headaches since his teens. He did not respond to a wide variety of drugs and non-drug therapies, but Emgality has been very effective. The only problem is that the effect lasts three and a half weeks. During the week before the next shot, his migraine headaches become severe and frequent. Sumatriptan helps but his disability as measured by the MIDAS scale is in the moderate range. He is a high-level executive in a large corporation and needs better control of his migraines. He had tried the other two monoclonal antibodies for migraines – Aimovig and Ajovy – and they were less effective.

Fortunately, there is a good solution to his problem. I advised him to take Emgality injections every three and a half weeks. This is a higher frequency than what is recommended by the FDA and some doctors and patients may have concerns about the safety. The one-month interval is based on averages derived from large studies. People, however, are not average. Some metabolize drugs faster or need a higher or a lower dose of a drug. Another reassuring fact about Emgality is that it is approved at a much higher dose for cluster headaches. For migraine, we give a 240 mg loading dose and then, 120 mg monthly. Patients with cluster headaches get monthly injections of 300 mg.

I have patients who have the same problem of the short duration of effect with Aimovig and Ajovy as well.

A major obstacle to the more frequent use of these drugs is the fact that insurance companies will only pay for 12 shots a year. These drugs cost about $600 to $700 a dose, so the cost is a major factor for many people. The way I get around it is by providing patients with free samples. Because we have three similar competing drugs, we get samples of all three. If you are having a similar problem, ask your doctor for a free sample. Some academic centers and large hospitals do not allow doctors to receive samples but most doctors in private practice can get them.

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I recently saw a 32-year-old woman who never suffered from headaches until a year ago when she was given an injection of a COVID vaccine (J&J). Her headache started the day after vaccination and it has persisted unabated. Besides severe daily headaches, she developed profound fatigue, muscle aches, and brain fog, making her unable to work. Her headaches had all the features of chronic migraines and I recommended trying Botox injections along with a migraine medication that she has not yet tried.

I’ve seen a few dozen patients who developed less devastating headaches or whose preexisting migraines worsened after vaccination. Some developed a headache after the first or second shot and a few had it only after the booster. I am not suggesting that people should avoid the COVID vaccine. I’ve had three shots myself. I am writing about this because of a study just published by European researchers in the Journal of Headache and Pain“Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.”

They examined the results of 84 scientific reports that included 1.57 million participants, 94% of whom received Pfizer or Oxford-AstraZeneca vaccines. They discovered that vaccines were associated with a doubling of the risk of developing a headache within 7 days from the injection compared to people who received a placebo injection. They did not find a difference between the two different vaccine types. Some people developed a headache within the first 24 hours. In approximately one-third of the cases, headache had migraine-like features with pulsating quality, phonophobia, and photophobia. In 40 to 60% the headache was aggravated by physical activity, which is another migraine feature.

The majority of patients used some medication to treat their headaches. People reported that the most effective drug was aspirin, although the details about various treatments were not provided. We do know that in Europe doctors are much less likely to prescribe medications, including triptans. It is likely that early and aggressive treatment can prevent these headaches from becoming chronic and disabling.

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A patient recently asked me about trying chiropractic treatment for her migraines. This is a chapter on chiropractic from my last book, The End of Migraines: 150 Ways to Stop Your Pain.

Chiropractors can also relieve migraines if they are skilled and talented. Norwegian researchers conducted a study of chiropractic manipulation for migraine headaches in 104 patients. They divided patients into three groups. One group received real chiropractic manipulation of the spine, another one received a sham treatment that consisted of just putting pressure over the shoulders and lower back, and the third group continued their usual medication. The real and sham chiropractic groups received 12 treatment sessions over 12 weeks. Patients were followed for a year. After 12 weeks patients in all three study groups reported improvement. However, a year later, only the chiropractic groups still felt better. On average, they had about four migraine days a month, down from six to eight before the treatment started. Patients who continued their medications lost all of their improvement and their migraine frequency was back where it was at the baseline.

The results published in the European Journal of Neurology suggest that chiropractic is indeed effective in reducing migraine frequency. However, it also suggests that any hands-on treatment is equally effective. This probably explains the popularity of chiropractic, physical therapy, massage, reflexology, Reiki, energy therapies, and other hands-on treatments.

The same word of caution applies to chiropractic as to yoga. Avoid having high-velocity adjustments – sudden upward pulling and twisting of the head. These adjustments carry a small but not negligible risk of stroke due to a dissection of an artery which is described at the end of this book. I was once consulted on an older man in an emergency department who was found to have a subdural hematoma (bleeding inside the skull) after receiving a chiropractic neck adjustment.

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I am honored to speak (in person) at this patient advocacy event. My topic will be, When treatments stop working, what’s next?

Here is some information and a link:

RetreatMigraine 2022: April 1-3 at Hilton Charlotte University Place
RetreatMigraine is a conference specially designed by and for adults living with migraine disease. The multi-day event brings together patients, care partners and migraine experts to support and strengthen our community. In 2022 RetreatMigraine will be a hybrid event. In-person capacity is for 300+ attendees and virtual capacity is unlimited. The conference offers interactive sessions that provide disease and treatment education, advocacy training and complementary therapy experiences.
This conference is organized by CHAMP – Coalition for Headache and Migraine Patients.

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See Julie’s solo show at Shrine.nyc, 179 East Broadway, New York, NY

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Botox is one of the most effective and safest treatments for frequent and chronic migraines. One of the potential side effects of Botox is droopy eyelids. When injections are done correctly this happens in a very small percentage of patients. This is more common in older people partly because with age eyelids tend to sag naturally and partly because relaxing wrinkles makes the skin of the forehead relax down. Sometimes, what droops are not the eyelids (ptosis) but the eyebrows (brow ptosis). In either case, it can cause not only a cosmetic problem but can also interfere with vision.

If this happens, two types of eye drops can help lift the eyelids. Apraclonidine (Iopidine) is an old medicine for the treatment of glaucoma. It tightens the eyelid muscle and makes the eylid move up. Oxymetazoline (Upneeq) was approved by the FDA in 2020 to lift droopy eyelids that occur with age (acquired blepharoptosis). Although oxymetazoline is specifically approved for droopy eyelids, I mostly prescribe apraclonidine because of a large cost differential. Oxymetazoline is a branded product protected by a patent, while apraclonidine is an inexpensive generic drug.

Another way to provide temporary relief is to use double-sided eyelid tape.

For one of my patients, none of these methods worked. She developed droopy eyelids every time she had Botox injections even when injections were given high up in the forehead. And she needed those areas injected because her migraine pain was localized to the forhead. She solved this problem by having a plastic surgeon perform a surgical eye lift. This allowed her to continue Botox injections without any side effects.

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I am happy to announce that you can attend the Migraine World Summit free of charge. It is back on March 16-24, 2022 for its 7th annual virtual event. As one of the former presenters, I can tell you that you may greatly benefit from learning about the latest research on how to best manage migraine.

Migraine World Summit is a 9-day event where 32 of the world’s leading experts on migraine and headache research are interviewed on topics voted on by real patients. These interviews are online and can be accessed from anywhere in the world, but are only available free during the 9-day event.

Get your ticket today at MigraineWorldSummit.com

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Nerivio, an electrical stimulation device was cleared by the FDA to treat acute migraine attacks in adults almost three years ago. It was recently also cleared to treat migraines in adolescents. A new study sponsored by Theranica, the manufacturer of Nerivio shows that combining this device with relaxation and education improves its efficacy.

Remote electrical neuromodulation (REN) is the official term for passing an electrical current through the arm in order to treat migraine headaches. Theoretically, other painful conditions can be also treated by electrical stimulation applied outside of the area of pain. Currently, however, there is only only one such device, Nerivio, and it is used to treat migraine headaches.

I’ve prescribed this device (and it still needs a prescription) to hundreds of patients. About half of them find it effective and continue using it. Some of my patients have remarked that not only their migraine improves, but they also feel more relaxed. I was a bit surprised because they are supposed to crank up the current to the point just below where it becomes painful. But even if you don’t feel relaxed, it makes sense for all patients to try to relax during this treatment which typically takes 45 minutes.

Theranica sponsored a trial that combined electrical stimulation with what they call Guided Intervention of Education and Relaxation (GIER). This consisted of a 25-minute video played on the user’s smartphone during the treatment. It trains patients in three relaxation techniques: diaphragmatic breathing, progressive muscle relaxation, and guided imagery. It also provides pain education about migraine biology and electrical stimulation.

The results of this trial were just published in the journal Pain Medicine. The lead author, Dr. Dawn Buse is a psychologist and one of the leading headache researchers.

The results in the group that used only Nerivio were consistent with those found in previous controlled trials – 57% of patients had consistent pain relief in more than 50% of their attacks, 20% had complete elimination of pain, 53% had improvement in function, and 18% were able to return to normal functioning within 2 hours after treatment.

Patients who combined Nerivio with GIER did better. 79% had pain relief, 71% had improved functioning, and 38% returned to normal functioning.

Nerivio is used through an app that is downloaded into a smartphone. This gives the company a perfect opportunity to easily enhance the efficacy of its product.

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My previous post described a study that found no difference in efficacy among different types of psychosocial interventions for the treatment of chronic back pain. A recent 2020 Cochrane review concluded that there is strong evidence that face-to-face treatments based on cognitive behavioral therapy (CBT) have a small beneficial effect on reducing pain, disability, and distress in people with chronic pain.

A meta-analysis just published in the journal Pain examined the efficacy of CBT delivered via the internet. Australian researchers examined 36 studies with 5778 participants. Most participants were female, and most studies recruited participants from community settings through online advertisements in Western countries.

They concluded that “internet-delivered cognitive and behavioural interventions can result in small significant improvements in interference/disability, depression, anxiety, pain intensity, self-efficacy and pain catastrophizing. Guided interventions may result in greater treatment effects for key outcomes in pain management, including interference/disability, anxiety and pain intensity.”

The meta-analysis showed that guidance by a clinician improves the results. However, this guidance varied across the studies in terms of
how it was provided (e.g., via secure email, SMS messages, telephone calls), the timing and frequency with which it is provided (e.g., weekly, on demand, or at set time points), the amount provided (e.g., brief versus extended), and the professional qualifications and experience of those providing it (e.g., students-in-training, registered psychologists, non-health professionals). There was no difference between the traditional CBT and ACT (acceptance-commitment therapy), confirming the results described in my previous post.

There are several sites that offer CBT courses over the internet. ThisWayUp.org.au and moodGYM.anu.edu.au, online-therapy.com, and others. During the pandemic almost all social workers and psychologists switched to virtual appointments. Lower cost is the advantage of self-directed online CBT courses.

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