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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New Guidelines from American Academy of Neurology On Reduction of Migraine Frequency

New guidelines or strategy if you will, have been chalked out and released by scientists at the American Academy of Neurology in conjunction with the American Headache Society on the approach migraineurs should take to reduce the frequency of their attacks. These guidelines have been released just this week and basically are a little different from the previous guidelines in terms that they reduce the ranking of certain migraine drugs (such as Verapamil and Gabapentin) which were highly recommended in the last guidelines due to evidence gathered against them. In addition, the new guidelines are based on evidence-based research on a larger population than were done for the last set of guidelines covering various demographics – gender, races etc. (1)

Want Fewer Migraine Attacks? Follow a Preventative Regimen Everyday (2)

As per the neurologists, almost 38% of all migraineurs should follow a preventative strategy to reduce the number of their migraine episodes. But only a third of that percentage followed a daily preventative regimen with the rest of them only resorting to band aid approaches and tackling the pain once they are in the throes of a migraine attack or are expecting one within a few hours. The approaches they often took were such as were not proven effective in scientific testing before.

According to Mark Green, MD, director of the Headache Center at Mount Sinai School of Medicine, in New York, “What the guidelines do is pinpoint first-line treatments based on evidence and effectiveness.  If these guidelines are used widely, we will be able to up the odds of reducing headaches by 50 percent. Moreover, the stakes may be high if we undertreat migraines. Evidence is building to suggest that if we allow migraines to progress, the frequency of attacks may increase, and they may also become harder to treat” (3)

Here’s a quick look at what the evidence-based preventative guidelines suggests to migraineurs:

  1. First line prescription drugs must be taken on a daily basis to bring down the number and intensity of the attacks.
  2. Effective For Prevention: Anti-seizure medications Divalproex sodium, Sodium valproate, Topiramate, Metoprolol, Propranol, Tumolol.
  3. Effective Herbal Preparations: Butterbur / Petasites.
  4. Probably Effective: Nonsteroidal anti-inflammatory drugs or NSAIDS such as Fenoprofen, Ibuprofen, Ketoprofen, Naproxen, Naproxen Sodium, Subcutaneous histamine, Complementary treatments, Magnesium, Riboflavin, Feverfew.
  5. Found Not Effective: Anti-seizure drug lamotrigine was not effective in preventing migraine.

SOURCES:

  1. New Guidelines Assert That Daily Preventive Therapies Significantly Reduce Migraines; Newswise; April 2012; http://www.newswise.com/articles/view/588495/?sc=rsmn&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+NewswiseMednews+%28Newswise%3A+MedNews%29
  2. Image by Ambro; Freedigitalphotos.net; April 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1499
  3. New Guidelines: Treatments Can Help Prevent Migraine; American Academy of Neurology (AAN); April 2012; http://www.aan.com/press/index.cfm?fuseaction=release.view&release=1062

Video of the 2012 AAN Conference may be accessed at:

  1. 2012 AAN Press Conference: New Guidelines on Preventing Migraine Headache; YouTube.com; April 2012; http://www.youtube.com/watch?v=LoKPwq9JcKE&feature=g-upl&context=G2423319AUAAAAAAAAAA

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