Newly FDA-Approved Topamax For Migraines Raises Concerns Over Serious Side-Effects

Topamax

Recently-approved Topiramate For Adolescents Needs A Look Into Serious Side-Effects (1)

The Food and Drug Administration of USA recently (end of March 2014) approved the use of chemical topiramate in the 12 – 17 years of age group to prevent migraines. Topiramate is manufactured by drug corporation Janssen and sold under the name of Topamax. Such adolescents who report to a minimum of migraine episodes every month and have been given a clinical diagnosis of migraines in the last 6 months qualify for receiving a prescription of Topamax from their doctors to be used as a prophylactic medication.

Topamax originally came into the market in 1996 to treat seizures experienced in epileptic patients and was later also extended to manage other conditions such as need to reduce weight in obese and overweight patients.

However, the initial euphoria of being able to avail of the benefits of this drug are now subsiding with concerns that have been put forward by analysts from consulting firm GlobalData, on the severe side-effects Topamax comes with and those that have long been known to occur in adult patients. They are likely to be experienced by the adolescent migraining population as well and require a serious risk-benefit analysis before receiving a prescription.

Topamax is known to cause side-effects such as tiredness, dizziness, coordination problems, speech problems, changes in vision and sensory distortion.(2) In some cases it may cause sudden loss inn vision, memory problems, problems remembering words, brain fog, decline in cognitive condition and behavioral changes and the like.

As per GolbalData analyst Alvina To, “Migraine is experienced by both children and adults alike. For children in particular, these symptoms can affect school performance, social interactions and family life. The good news is that Topamax proved safe and well-tolerated in this patient group. But as with all anti-epileptic drugs, Topamax may also increase the risk of suicidal thoughts and behaviors in patients, as well as boosting the chances of cleft lip and/or cleft palate development in infants born to women who take the drug during pregnancy. It is therefore essential that all associated risks and benefits of Topamax are carefully assessed.” (3)

Randomized and placebo-controlled tests on Topiramate as well as trials on safety for this young age group was conducted on 103 patients who were diagnosed with migraines. In 72% of these patients, migraines were significantly reduced compared to 44% who took placebos.

Thus instructions have been given to neurologists to dispense a Medication Guide that spells out the safety and what to expect from the drug at time of giving a prescription. According to Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, “Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices.” (4)

Topamax tablets are available in potencies of 25 mg, 100mg and 200 mg.

SOURCES:

  1. Image Credits: Topamax; Pharma Agora; Web April 2014; http://www.pharma-agora.com/product/detail/1524-topamax-sprinkle-25mg; http://www.pharma-agora.com/product/detail/1524-topamax-sprinkle-25mg
  2. Topamax Side Effects Center; Rx List; Web April 2014; http://www.rxlist.com/topamax-side-effects-drug-center.htm
  3. Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval; The Pharma Letter; Web April 2014; http://www.thepharmaletter.com/article/topamax-safety-concerns-as-a-treatment-for-migraines-in-adolescents-despite-recent-fda-approval
  4. FDA approves Topamax for migraine prevention in adolescents; FDA News Release; Web April 2014; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391026.htm

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Bridging the Gaping Divide With Pain Self-management Tools

Most migraineurs are aware that the medical fraternity has yet not arrived at the cause of migraines. We know of triggers and the way the pain unfolds or what happens inside of the brain hours before, during and after a migraine episode but are still clueless about what causes migraines and why or how the pain stops.

Though a good number of migraineurs do consult a ‘migraine specialist’ or a ‘headache specialist’ after enduring the onslaught of merciless pain years after they first experienced their episodes, they often take back selective important tips back from the doctor’s office. A relatively new program called painACTION.com developed by Inflexxion now offers many tools to the migraineur that can help them manage their symptoms better when they are out of the doctor’s office and back into their lives.

Better Pain Management With Online Self-help Application (1)

This free and non-promotional program is available online and is believed to be especially beneficial to those who are chronic migraineurs. The tool was studied by researchers at Inflexxion using 185 participants to test the clinical efficacy of this web-based program. The program uses various symptom-based management techniques and offers a wide range of tips on relaxation and on getting support groups, doing daily activities to do etc.

It was observed that those who used the program reported better stress and pain management skills, were more confident in their ability to handle an episode. The study as well as it’s findings were reported in the medical journal The Journal of Head and Face Pain, titled ‘A Randomized Trial of a Web-based Intervention to Improve Migraine Self-Management and Coping’. (2)

According to the lead author and researcher, Jonas Bromberg, PsyD, Director of Health Communications and Senior Research Scientist at Inflexxion, “Self-management training should help patients learn how to identify, avoid, and manage headache triggers, and learn to perform other essential prevention, management, and coping behaviors. The integration of behavioral support in the medical care of migraine is essential in helping people with migraine to manage their condition more effectively, safely manage their prescription pain medications, avoid disease progression, and reduce the high cost of migraine and migraine-related disability to individuals and society.” (3)

This free online program is particularly beneficial to those who live and work in areas which do not have easy or ready access to neurologists, mental health support services or behavioural experts.

SOURCES:

  1. Image by Jeroen van Oostrom; Freedigitalphotos.net; February 2012;  http://www.freedigitalphotos.net/images/view_photog.php?photogid=413
  2. Technical report of the study may be accessed at: A Randomized Trial of a Web-Based Intervention to Improve Migraine Self-Management and Coping; Wiley Online Library; February 2012; http://onlinelibrary.wiley.com/doi/10.1111/j.1526-4610.2011.02031.x/abstract
  3. Migraine Self-Management Improved And Migraine-Related Psychological Distress Reduced By painACTION.com; Medi Lexicon News; February 2012; http://www.medilexicon.com/medicalnews.php?newsid=241832

The web-based program may be accessed through this link: http://painaction.com/

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De-mystifying Migraines In Women

I was struck by the statistics on migraineurs worldwide published by the WHO. Apparently, 303 million people the world over suffer migraines, out of which women account for 70% of the patients. India alone has 100 million sufferers and the US has 30 million patients. The report went on to add that it is estimated that 20 million migraine attacks happen everyday!!!! Staggering by any scale.

Though a lot of cutting edge research has been done, especially in the last decade to control this beast, scientific reports still grapple with unknowns, and are still clueless on issues such as why or how magnesium release regulates calcium ions in the neurons or why a certain chain of events takes place in the cranium that bring on migraines or even why they wind up.

With so much still in the grey, one wonders when and if help will come from drugs that will be safe to consume in the long run or if there are any strategies out there to shake this neurological disease.

In my book, ‘Migraines for the Informed Woman’, I have attempted to simplify the esoteric jargon of research papers and scientific material on migraines. After more than one decade of trying most therapies, I have come to the conclusion, that some work and others that are not as effective. More importantly, I have come to realise that certain mixes of therapies done simultaneously work wonders.

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