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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FDA Approves Hi Tech Headband That Prevents Migraines

CEFALY

The Cefaly Headband That Prevents Migraines (1)

Engineers and pharmacists at STX-Med from Belgium have come up with a sophisticated electronic device that excites precisely the sensitive nerve cells to treat pain and motor neurons to obtain muscle contraction or treat muscle spasms. Known as the Cefaly, it has now been approved for sale in the US by the FDA. The device is already in usage among migraineurs in France, Canada, Australia and elsewhere. This external headband that offers neuro-stimulation is worn in particular to treat both migraines and tension headaches. (2)

The Cefaly is a battery-powered headband that emits electric currents to stimulate the nerves that are involved in migraine episodes. Tests on 67 patients have shown that this device reduces not only the total number of migraine attacks per month but also decreases the intensity of an attack.

The device is based on TENS (or Transcutaneous Electrical Nerve Stimulation) technology that has been studied in the medical circles for over four decades. The usage of TENS techniques is however, contraindicated under certain situations. (3)

The Cefaly device is meant to be administered on migraine patients and those with joint pains who are 18 years and older and for no longer than 20 minutes a day. The medical device is both CE and ISO certified for safety and performance as well as effectiveness.

It is believed to be 25% more effective than any other migraine management options available through prescription and is also effective in conditions such as insomnia and anxiety.

About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use. (4)

For details of the study and a word from the doctors and developers, WATCH VIDEO: Migraine Relief Using New FDA-Approved Portable TENS Device ; Liberty Voice; Web March 2014; http://guardianlv.com/2014/03/migraine-relief-using-new-fda-approved-portable-tens-device/

SOURCES

  1. Image Credits: Cefaly Drug-Free Migraine Pain Relief; Cefaly; Web March 2014; http://www.cefaly.ca/
  2. FDA Approves Electric Headband to Prevent Migraine; ABC News; Web March 2014; http://abcnews.go.com/Business/wireStory/fda-approves-electric-headband-prevent-migraine-22866209
  3. FDA approves electric headband that prevents migraines; MedCity News; Web March 2014; http://medcitynews.com/2014/03/fda-approves-electric-headband-prevents-migraines/#ixzz2vj7F2HGq
  4. FDA Approves Electric Headband To Prevent Migraine; NPR; Web March 2014; http://www.npr.org/templates/story/story.php?storyId=289099411

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Implant To Pull The Plug On Migraine Pain

implant to cut off pain

 

Implant That Cuts Off Pain (1)

Another hand-me-down tool in the pain management kit for migraineurs but one that shows promise for the chronic migraineur. Patients who have tried almost all routes to seek relief from popping in painkillers and taking prescription opoids, having botox injected, trying hypnosis and biofeedback as well as other alternative therapies like shiastu and autogenic training but have turned to the doctor dismayed with the results now have hope. There appears to be one last technique/tool that some doctors may suggest to such patients. It is not meant for all migraineurs and is suggested on a case to case basis. It is yet to be approved by the Food and Drug Administration (FDA).

The device was designed for patients of chronic back pain. But now it is holding hope for migraineurs who have tried everything and have no other corner to turn. According to Jenny Bruner who had been dealing with the onslaught of pain for many years, “I went to a neurologist. I was hospitalized. Then they put me on preventative medicines.  We tried acupuncture, even botox. I tried biofeedback, and nothing was working. I didn’t see any hope.  It was so frustrating just living in constant pain. It’s unbearable because you are not able to eat because you are nauseated all the time.” (2) During her years with the neurological disease she tried as many as 62 different medications with little or no help from any.

However, she did in the course come across a management technique involving neuro-stimulation. The treatment was called Transforma and it gave her considerable relief like no other technique or medication had.

The system involved the implantation of tiny leads just below the skin. These sub-cutaneous leads are connected to a battery pack. This battery is implanted in the lower back of the patients. The battery sends electrical pulses of very low voltage to the areas of the brain that process pain and is involved in pain signalling. The beauty of the system is that the migraineur can adjust the voltage strength according to her/his needs or the level of pain being experienced in a migraine episode. The electrical pulses feel like a mild massage.

According to migraine specialist Dr. Jack Chapman, “We are turning on a small electrical signal to the nerve to basically shut off or change that nerves transmission of the pain that people interpret as a headache.” (3) To Bruner, this has been a life-changing treatment. She has retrieved bits of life that she had to let go off.

SOURCES

  1. Image Credit: Asian Girl With Headache; tokyoboy; Freedigitalphotos.net; web October 2013; http://www.freedigitalphotos.net/images/Healthcare_g355-Asian_Girl_With_Headache_p86098.html
  2. Relief for migraine sufferers thanks to small electronic device; ClickOrlando.com; Web October 2013; http://www.clickorlando.com/news/relief-for-migraine-sufferers-thanks-to-small-electronic-device/-/1637132/22282540/-/t3xan8z/-/index.html
  3. New treatment helping people with migraines; WNDU.com; Web October 2013; http://www.wndu.com/news/specialreports/headlines/New-treatment-helping-people-with-migranes-226347731.html

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FDA Grants Approval To Rizatriptan Benzoate ODT For Acute Migraine Treatment

Migraine Blog Rizatriptan ODT

Rizatriptan Benzoate ODT approved by FDA and launched in the market.  Image is not of said drug (1)

Pharmaceutical company Breckenridge’s drug Rizatriptan Benzoate has been given the green flag for immediate launch by the U.S Food and Drug Administration. The drug comes in the form of orally disintegrating tablet (ODT). It is available commercially in packs of potency/dosage 5 mg and 10 mg.

Breckenridge’s drug Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited. Just like Merck & Co. Inc’s Maxalt MLT, Rizatriptan Benzoate ODT is a prescription drug used in the management and treatment of acute migraine.

The FDA granted final ‘go ahead’ for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate ODT some nine months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).

‘Breckenridge’s patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.’ (2)

SOURCES:

  1. Image Credit: FreeDigitalPhotos.net; Yellow Tablet; Image by rakratchada torsap; Web July 2013; http://www.freedigitalphotos.net/images/agree-terms.php?id=10096441
  2. Breckenridge Pharmaceutical, Inc. Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets): BioSpace.com; Web July 2013;  http://www.biospace.com/news_story.aspx?StoryID=301892&full=1

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Cambia Approved For Migraines In Canada

Health Canada has given a notice of compliance/approval to Stellar Pharmaceuticals’ generic drug Cambia. Cambia is used for the treatment of acute migraines in adults with or without aura. The chemical composition of this oral solution comprises of diclofenac potassium. Cambia is actually manufactured by Tribute Pharmaceuticals, a wholly owned subsidiary of Stellar Pharmaceuticals. (1)

Cambia (R) – Diclofenac Potassium Approved In Canada For Migraineurs(2)

This is a relief to the Canadian migraineurs as the generic drug is affordable. In Canada Cambia will be marketed exclusively by Nautilus Neurosciences. Oral tablets of diclofenac potassium have been available to the U.S patients since May 2010 after FDA approval. Diclofenac Potassium is a non-steroidal anti-inflammatory drug (NSAID) and a benzeneacetic acid derivative.

Cambia and other brands of diclofenac potassium are contraindicated for use in persons with cardiovascular condition, peri-operative pain in the setting of coronary artery bypass graft and those with gastrointestinal sensitivity and conditions.

According to Rob Harris, President and CEO of Stellar Pharmaceuticals, “We feel that CAMBIA(R) represents a logical first line prescription treatment choice for acute migraine, especially when over-the-counter medicines that offer some relief with milder forms of migraine pain fail, and where side effects or tolerability issues with the triptan class of drugs becomes a concern. With CAMBIA(R), Canadian physicians now have a new treatment option with comparable efficacy to the oral triptans but with a faster onset of action.”(3)

SOURCES:

  1. Nautilus Neurosciences, Inc. Announces a New Approval for CAMBIA® for the Acute Treatment of Migraine; Marketwatch -PR Newswire; March 2012; http://www.marketwatch.com/story/nautilus-neurosciences-inc-announces-a-new-approval-for-cambia-for-the-acute-treatment-of-migraine-2012-03-19
  2. Image by Stuart Miles; Freedigitialphotos.net; March 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=2664
  3. Health Canada Approves CAMBIA(R) for the Treatment of Acute Migraine; Marketwatch – Marketwire- Press Release; March 2012; http://www.marketwatch.com/story/health-canada-approves-cambiar-for-the-treatment-of-acute-migraine-2012-03-16

 

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