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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Why NICE (U.K) Will Not Recommend Botox As Migraine Preventative Any Time Soon

National Institute for Health and Clinical Excellence (NICE) in the U.K will not be endorsing the use of purified botulinum toxin A (Botox) as a preventative for migraineurs anytime yet. According to sources, there is not enough evidence that confirms the efficacy of Botox in pain management. This news comes as a bit of a surprise especially because back in the summer of 2010, Medicines and Healthcare Products Regulatory Agency (U.K) had approved the use of Botox in migraine management. Here is a news report that runs in News- Medical.Net written by Dr. Ananya Mandal MD (1):

Botox Being Injected Into a Migraineur (2)

“Botox – used as an anti-wrinkle agent – is unlikely to be recommended for the treatment of chronic migraines on the NHS in England and Wales. According to the National Institute for Health and Clinical Excellence (NICE) draft guidelines there is insufficient evidence that it works.

Migraines are severe headaches, which are often accompanied by nausea and vomiting and finding light or sound painful. Chronic migraines are defined as headaches at least 15 days a month, eight of which have to be migraines.

In July 2010, Botox was approved as a preventive treatment for chronic migraine in the UK by the Medicines and Healthcare Products Regulatory Agency. Botox is injected into at least 31 sites around the head and neck every 12 weeks. However, how the neurotoxin might prevent chronic migraines is unknown. The therapy uses a purified version of botulinum toxin A and it is thought to block overactive nerve impulses which trigger excessive muscle contractions.

NICE is deciding whether the injection should be offered across the NHS in England and Wales. NICE said the injections had been “shown to have some benefit” such as in a trial involving 1,384 patients, published in the journal Headache. However, it said the effect was small and may have been confused by the way the studies have been conducted. A review in the Drug and Therapeutics Bulletin in February 2011 said there is “limited evidence” for using Botox.

Prof Carole Longson, director of the health technology evaluation centre at NICE, said, “Our independent committee is asking Allergan to provide further information and analysis as part of this public consultation, so that it has sufficient evidence to develop sound advice for the NHS regarding the use of Botox for the prevention of headaches in adults with chronic migraine. Without this additional evidence, potentially we will be unable to advise the NHS that this drug is good value for money for these adults because there are currently too many uncertainties.” NICE estimated the cost to the NHS would be £349.40 for every 12-week cycle of treatment.

Allegan said it was “working constructively” and would provide new evidence to NICE which it said would demonstrate “that treatment with Botox is both a cost effective and clinically meaningful treatment option for patients suffering from this debilitating condition”.

The chief executive of The Migraine Trust, Wendy Thomas, told the BBC, “I’m a bit disappointed really. For these people with chronic migraine, they’ve already tried various preventative treatments which have failed. For these people their only hope is Botox. It doesn’t work for everybody – it can change people’s lives or not make very much difference.”

Joanna Hamilton-Colclough, director of Migraine Action, said using Botox for her headaches had “absolutely transformed my life”. She said, “I’ve been having chronic headaches for 40 years – I wake up every day with a headache. After my first Botox treatment I woke up the next day feeling ill. At lunchtime I realized that I felt different because I didn’t have a headache. I’ve been able to work without a headache and sleep properly for the first time.” She admitted it did not work for everyone but added that clinical trials also suggested a 50 per cent reduction in migraine days for some patients.

Mrs Hamilton-Colclough said, “We don’t think the treatment is expensive when you take into account the cost to the economy from people needing time off work for migraine and to the NHS from A&E treatment.”

Professor Anne MacGregor, a migraine expert at St Bartholomew’s Hospital, London, said she was concerned Botox might be used as a ‘quick fix’ for chronic headaches. She added, “It’s not a blanket treatment but it might be appropriate for a small number of patients.”

A decision from NICE is expected in June.”

SOURCE:
1. Botox efficacy uncertain in treating migraine says NICE; Medical News.Net; February 2012; http://www.news-medical.net/news/20120218/Botox-efficacy-uncertain-in-treating-migraine-says-NICE.aspx

2. Image by Ambros; Free Digitial Photos; February 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1499