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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Candesartan Gives Migraineurs New Hope: Study

cipsartan16mg

 

Candesartan seems to reduce incidences of migraines just as well as Propranolol (1)

Hope comes for migraineurs via a new study conducted by St. Olavs Hospital in Trondheim, Norway and the Norwegian University of Science and Technology. Migraine patients who have been prescribed propranolol, (a popular beta-blocker that also doubles up to reduce the number and severity of migraine episodes) as a migraine prophylactic but get no relief from taking it can now breathe a sigh of relief as the study demonstrates that chemical candesartan proves as if not more effective for migraine prophylaxis.

Though the theory of candesartan working as an effective migraine prophylactic had been propounded more than a decade ago, it has been proved only now that the drug actually works. In the study, the placebo administered showed a 20% ‘feel-better’ on patients but administering of candesartan exhibited an additional 20-30% patients’ ‘feel-better’. (2)

Candesartan is a blocker of the angiotensin II receptor. Angiotensin is a peptide hormone that constricts blood vessels causing the blood pressure to rise and the heart to pump blood harder. Blocking receptors that receive angiotensin hormone helps relax/dilate the blood vessels thereby lowering blood pressure and easing the heartbeat. (3)

The study which examined 72 migraineurs who had migraines at least twice every month, was a triple blind test in which neither neither patients nor doctors nor those who analyzed the results knew whether the patients had been given placebo or real medicine. The patients used each treatment (candesartan, propranolol or placebo) for 12 weeks, and also underwent four weeks before start and between the treatment periods without any medication at all. Thus every patient was part of the study for almost a year.

According to Professor Lars Jacob Stovner, leader of Norwegian National Headache Centre, “This gives doctors more possibilities and we can help more people.” (4)

Common side effects of candesartan are: dizziness, fatigue, abdominal discomfort, headache and reduced renal functions.

Atacand (AstraZeneca), Cipsartan (Cipla) are some popular brand names under which Candesartan is sold. Propranolol on the other hand is sold under the brand names Inderal, Inderal LA, InnoPran etc.

SOURCES

  1. Image Credit: Cipsartan-16 (Candesartan Cilexetil Tablets 16 mg) from Cipla; pharmacywebstore.com; Web January 2014; http://bit.ly/1aqwpIO
  2. New Hope for Migraine Sufferers; ScienceDaily.com; Web January 2014; http://sciencedaily.com/releases/2014/01/140113104841.htm
  3. Angiotensin II receptor blockers; Diseases and Conditions; Mayo Clinic; Web January 2014; http://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/angiotensin-ii-receptor-blockers/art-20045009
  4. University of Science And Technology – News’ Web January 2014; http://www.ntnu.edu/news/2014/migraine-help

For more details of the study, please visit:

A Comparative Study Of Candesartan Versus Propranolol For Migraine Prophylaxis: A Randomised, Triple-Blind, Placebo-Controlled, Double Cross-Over Study; Sage Journals – Cephalagia; Web January 2014; http://cep.sagepub.com/content/early/2013/12/11/0333102413515348

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Migraine Symptoms & Some Fixes

Besides the debilitating pain, migraineurs often experience some symptoms that precede and/or last during the time the migraine episode is on. Here’s a list of some of the symptoms a migraineur may experience before or during an attack:

  • Nausea
  • Dizziness
  • Sleep disturbances
  • Visual disturbances/aura
  • Hyper-sensitivity to sound
  • Hyper sensitivity to light
  • Increased sensitivity to odours
  • Frequent yawning
  • Frequent need to urinate
  • Constipation
  • Diarrhea
  • Non-visual aura
  • Confusion
  • Fatigue

Symptoms and Some Fixes (1)

The exact reason why a migraine attack begins is not yet clear to scientists. However, based on years of data gathered from cases that report for treatment assistance to clinics and hospitals, several migraine triggers have been identified.

Despite the extreme discomfort migraines give, it is possible to obtain symptomatic relief at least some extent. Here are a few tips at what can be done should you be in the grips of a migraine attack. However, it is important to keep in mind that the priority is get a medical help and consultation at the earliest. The tips below are to serve only till you are able to see a doctor. (2)

  • Excruciating pain

Pain may be tackled with NSAID (Non-Steroidal Anti Inflammatory Drugs) brufen, naproxen, diclofenac sodium etc. It may also be managed by analgesics such as paracetamols, spirins etc. However, it is recommended that you take any one of them as per the dosage and instructions on the label after a light meal of complex carbohydrates or some non-acidic foods. It is important that painkillers be taken at the first signs of migraine. Putting an ice pack on the painful area also helps. (3)

  • Nausea

Nausea may be tackled with taking of anti-emetic along with the analgesic in the prescribed dosage. It is also important to not stay on an empty stomach for long durations. A light snack taken frequently helps in stubbing the queasiness and helps by utilising the excessive bile migraineurs release during attack episodes.

  • Visual Aura

The best way to manage a visual aura is to stop or put down what you are doing and stand until you can get to a place where you can sit or lay down. It is dangerous to operate any machinery or drive at such times. Breathing in deeply and fully and massaging of temples with a balm may aid temporarily.

  • Light and sound sensitivity

Going to a dark room or one with curtains drawn and lights turned off helps. Wearing dark glasses helps when outdoors. Noise disturbances may be managed with an earplug or by putting cotton wool in the ears to keep out or dull the surrounding noises.

  • Constipation

Constipation may be helped by taking tepid fluids such as warm milk or ginger tea or warm water etc. It is also advisable to have allergy-free natural laxatives like flaxseeds and high fiber diet including wholegrain cereals if you are gluten tolerant.

  • Diarhhea

Yet another accompanying nuisance with migraines, diarrhoea may be managed by taking stomach-binding foods and avoiding those with high fibre content.

DIET INCLUSIONS:

Holistic Health Therapist recommended the inclusion of herbs such as feverfew, St. John’s Wort and butterbur in one’s diet. Conventional physicians are of the opinion that calcium and magnesium supplements help take the edge off migraines. Tryptophan and omega 3 rich foods and B vitamins are also advised by doctors.

Complementary Alternative Medicines offer support therapy that aid in the management of migraines. Help comes from the sciences of yoga, aromatherapy, massage, reflexology, shiastu, acupuncture, sujok, biofeedback, chiropractic, cranial osteopathy, homeopathy, ayurveda, reiki, Alexander technique, autogenic training etc

MAINSTREAM MIGRAINE MEDICATION

  • Excedrin Migraine

Excedrin is a leading non-prescription drug from Novartis from the acetaminophen or paracetamol family that uses a combination of paracetamol with caffeine and aspirin designed especially to tackle migraine pain. Excedrin is available in geltab, tablet and caplet forms. Dosage and frequency of drug intake should be as per label instructions or doctor’s advice. It is important to understand and comply by the contraindications and warnings mentioned on the label of Excedrin Migraine and all other drugs.

Other ABORTIVE MEDICATIONS sometimes used by doctors are:

  • Analgesics: Aspirin, Paracetamol/Acetaminophen
  • NSAIDs: Ibuprofen, Diclofenac sodium, Fenoprofen, Ketorolac, Indomethacin, Tolmetin, Celecoxib
  • Ergotamines: Dihydroergotamine mesylate, Ergotamine tartrate
  • Corticosteroids: Methylprednisolone, decsamethasone
  • Opiods: Morphine, Codeine, Oxycodone
  • Combination: Analgesics containing barbiturates, analgesics containing opiods/narcotics
  • Triptans: sumatriptan succinate, Elitriptan hydrobromide, Almotriptan malate, Frovatriptan, Naratriptan

SECONDARY PROPHYLACTIC DRUGS (those that would keep the symptoms from getting worse) could also be recommended by the doctor to manage migraines. Examples are:

  • Anti-depresants: Phenelzine, Nortriptyline, Amitriptyline
  • Beta Blockers: Propanolol, Atenolol, Verapamil
  • Anti convulsants: Topiramate, Divalproex sodium
  • MAO inhibiters: Phenezine sulfate
  • Calcium channel blockers: Flunarazine (4)

SOURCES:

  1. Image by Michal Marcol; Freedigitalphotos.net. April 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=371
  2. How Can We Manage The Common Symptoms At Home; Migraines For The Informed Woman (Book); April 2012; http://www.amazon.com/Migraines-Informed-Woman-Tips-Sufferer/dp/8129115174
  3. Migraine Awareness Group: A National Understanding For Migraineurs (M.A.G.N.U.M); Treatment and Management- Current Treatment Methods – General Pain Management; http://www.migraines.org/treatment/treatctm.htm; 2006
  4. MedicineNet.com; Migraine Headache; Dennis Lee, MD, Harley I. Kornblum, MD, PhD; http://www.medicinenet.com/migraine_headache/page6.htm; 2010

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