Tagged: Retigabine

GSK’s Retigabine (Trobalt/Potiga) -Epilepsy Drug- Removed From The Market Due To Dangerous Side Effects..


So GSK are removing Retigabine (Trobalt/Potiga) after seven years on the market, because Retigabine causes serious eye problems, psychiatric side effects and other horrors… How come Seroxat/Paxil is still on the market?GSK… Helping you to do more, live longer and feel better…Yeah Right!..


3 Oct 2016

 

GlaxoSmithKline (GSK), the manufacturer of retigabine (brand name Trobalt), has announced it will permanently stop making this medicine from June 2017.

GSK says it is discontinuing this medicine for commercial reasons.

Only around 1,500 people worldwide currently take this medicine, and this number is getting smaller as doctors very rarely prescribe it.

GSK has advised doctors to start looking for other suitable medicines for any patients taking retigabine as soon as possible. It has told doctors that all patients should have stopped taking retigabine by the end of June 2017 at the latest.

If you take retigabine, your epilepsy specialist should talk to you about how to safely stop taking this medicine in plenty of time before June 2017. They may suggest switching you to an alternative treatment. If you are not due to see an epilepsy specialist in the near future, it is important to ask your GP to refer you.

 

 


 

The epilepsy drug Trobalt, also known as retigabine, is to be discontinued and will no longer be available after June 2017.

Trobalt, made by the pharmaceutical company GlaxoSmithKline (GSK) has been available in tablet form at 50mg, 100mg, 200mg, 300mg, and 400mg dosages.

Advice for healthcare professionals

Healthcare professionals are advised to begin seeking alternative medicines for existing patients as soon as possible and to ensure that all patients are withdrawn from this medicine by the end of June 2017 at the latest.

Patients’ treatment should be withdrawn with a gradual dose reduction over a period of at least three weeks, following current prescribing information. All patients should continue to receive safety monitoring in line with the local prescribing information while they remain on treatment with Trobalt. No new patients should now start on this treatment.

Safety issues

In 2013 GSK announced that there were safety issues around the drug as it could cause a blue discolouration of the skin and eye abnormalities. Doctors were urged to review patients prescribed the drug and to re-evaluate benefits versus risk.

However now, due to the very limited use of the medicine and the continued decline in new patients being prescribed Trobalt, GSK is discontinuing the medicine on a permanent basis.

Trobalt has been prescribed as an add-on treatment for drug-resistant partial onset seizures with or without secondary generalisation in people aged 18 or older.

More information

You can read more about anti-epileptic medication here.

Epilepsy helpline

Our confidential helpline is for anyone in the UK affected by epilepsy.

Call: 01494 601 400 (national call rate)
Daytime: Monday, Tuesday, Thursday and Friday 9am – 4pm
Extended hours: Wednesday: 9am – 8pm
Email: helpline@epilepsysociety.org.uk

Read more about the helpline here


 

https://www.gov.uk/drug-safety-update/retigabine-trobalt-indication-restricted-to-last-line-use-and-new-monitoring-requirements

Retigabine (Trobalt▼): indication restricted to last-line use and new monitoring requirements

Reports of pigment changes in ocular tissue, skin, lips or nails.

http://www.timeslive.co.za/world/2013/10/31/Glaxo%E2%80%99s-Anti-Seizure-Drug-Gets-Black-Box-Warning-on-Eye-Risk

Glaxo’s Anti-Seizure Drug Gets Black-Box Warning on Eye Risk

(Bloomberg) | 2013-10-31 19:47:21.0

GlaxoSmithKline Plc’s anti-seizure drug Potiga

GlaxoSmithKline Plc’s anti-seizure drug Potiga now carries a black-box warning in the US on risks including potential vision loss.

The warning, the most serious type the US Food and Drug Administration issues, underscores risks of abnormalities in the eye, vision loss and skin discoloration, all of which may become permanent, the FDA said in a statement today.

The revised label comes after the risks were flagged by the FDA in April.

Patients should have eye exams before starting Potiga and every six months during treatment, the FDA said. The drug accounted for 7 million pounds ($11 million) of the London-based company’s sales last year and is projected to bring in 39.5 million pounds this year, according to analyst estimates compiled by Bloomberg.

“In light of these reported adverse events, we have worked closely with regulators to update the medicine’s labeling to restrict its use to those patients where other appropriate medicine combinations have proved inadequate or have not been tolerated,” Glaxo said in an e-mailed statement today.

“We review the safety of all our medicines on an ongoing basis.”


 

https://www.epilepsy.org.uk/news/news/trobalt-update-%E2%80%93-last-line-therapy-63158

 

Trobalt: update – last-line therapy

5 Jun 2013

Blue pills

According to recent news reports, the epilepsy medicine Trobalt (retigabine) caused quite serious side-effects in some people. The European Medicines Agency has now issued a statement – advising that Trobalt become a last-line treatment

On 9 May, Epilepsy Today reported that the epilepsy medicine Trobalt (Potiga in the US) was causing some quite serious side-effects. These side-effects were experienced mostly by people with epilepsy who had been taking the drug over a long term.

The drug apparently causes a blue discolouration in the skin – in the fingernails and sometimes eye tissues. The effect on the eyes is the most worrying side-effect, since discolouration in the retina has been seen – which can lead to visual impairments.

A study is now being conducted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Fifty-five patients who have been taking the drug over a long period have now been examined. Out of those 55, 15 (over a quarter) had retinal pigmentation – discolouration in the light-sensitive part at the back of the eye.

Around a third of these 15 people also had evidence of visual impairment. The impairment was mild in most cases and it still unclear whether these people already had the impairment before their treatment with Trobalt. CHMP is also still looking into exactly how Trobalt may be causing this pigmentation.

CHMP considers the pigmentation in the eyes potentially serious, since it may lead to visual impairments. However, it also recognises that Trobalt may be effective in treating epileptic seizures that have not responded to other medicines.

Close-up of an eyeAs a result, the European Medicines Agency has advised that Trobalt only be used where no other medicine can control seizure activity. Any people with epilepsy being treated with Trobalt and who experience side-effects should discuss them with their doctor. After considering the risks and benefits, they should then decide whether to continue treatment.

The following advice was also issued to any people with epilepsy who are currently being treated with Trobalt.

  • Do not stop your treatment without talking to your doctor. Stopping epilepsy medicines may put you at risk of seizures (fits).
  • If you are currently being treated with Trobalt, your doctor may consider switching you to an alternative treatment.
  • During treatment with Trobalt, your doctor will request an eye examination for you at least every six months. If you experience changes in vision, talk to your doctor.
  • If retinal or vision changes are detected, the benefits and risks of continuing treatment with Trobalt will need to be re-assessed with your doctor.
  • Some people taking Trobalt have also had a blue-grey pigmentation of their nails, lips, or skin. If you notice such changes while taking the medicine, speak to your doctor.
  • If you have any questions, speak to your doctor or pharmacist.

A spokesperson from GlaxoSmithKline, who developed Trobalt, said: “Patient safety is our top priority and we review the safety of all our medicines on an ongoing basis. This includes the continued monitoring of patients who participate in our clinical trials after a medicine has been approved by regulators. In the case of retigabine (Trobalt), we have seen that after long-term treatment (generally occurring after 2 years of treatment) some of these patients have developed areas of blue-grey discolouration in eye tissues, including the retina, and/or of the nails, lips, and skin.

“Retigabine was initially approved for use as an add-on therapy for epilepsy patients whose condition was not adequately controlled on existing therapy. In light of the adverse events reported, we are currently working with regulators to update the medicine’s labelling to further restrict its use to those patients whose epilepsy cannot be controlled by other available combinations of medication.”

 

https://www.google.ie/search?q=trobalt&client=firefox-b-ab&tbm=isch&source=lnms&sa=X&ved=0ahUKEwibodrWounTAhUhDMAKHdcgB5wQ_AUIBigB&biw=1018&bih=651#tbm=isch&q=trobalt+eyes&imgrc=egFV_1ZTe-0DQM:

FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued 10-31-2013 and 6-16-2015.

View and print full Drug Safety Communication (PDF 145KB)

en Español

Safety Announcement

[04-26-2013]  The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration (See Photos) and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. All patients taking Potiga should have a baseline eye exam, followed by periodic eye exams. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available.

Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. It is not yet known whether the retinal pigment changes caused by Potiga lead to visual impairment, although several patients have been reported to have impaired visual acuity.

The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients (See Data Summary). In some cases, retinal abnormalities have been observed in the absence of skin discoloration.

In light of this new safety information, all patients taking Potiga or about to start Potiga should have an eye exam, followed by periodic eye exams thereafter (See Information for Health Care Professionals).  Potiga should be discontinued if ophthalmic changes are observed unless no other treatment options are available.  If a patient develops skin discoloration, serious consideration should be given to changing to an alternate medication.

Patients should not stop taking Potiga or any anti-seizure medication without talking to their health care professional, as stopping anti-seizure treatment suddenly can precipitate withdrawal seizures, a serious and life-threatening medical problem.

Facts about Potiga

  • Approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older.
  • From marketing in April 2012 through February 2013, approximately 10,900 prescriptions were dispensed1 and approximately 2,900 patients received a dispensed prescription for ezogabine from outpatient retail pharmacies.2  Based on sales distribution data, the majority of all ezogabine bottles (78% of ezogabine sales) were distributed to outpatient retail pharmacies.3

Footnotes

1 IMS Vector One®: National (VONA). April 2012-February 2013. Extracted March 2013.
2 IMS Vector One®: Total Patient Tracker (TPT). April 2012-February 2013. Extracted March 2013.
3 IMS Health National Sales Perspectives™. Year 2012. Extracted March 2013.

Additional Information for Patients

  • If you are taking Potiga and develop any changes in your vision or any discoloration of your skin, including of your lips and nail beds, contact your health care professional right away.
  • Do not stop taking Potiga without talking to your health care professional.  Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures.
  • Discuss any questions or concerns about Potiga with your health care professional.
  • Report any side effects you experience to your health care professional and the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Additional Information for Health Care Professionals

  • All patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG).
  • The latency of retinal abnormalities after treatment initiation is unknown, although all known cases of retinal abnormalities were reported after an exposure to Potiga of at least three years. It is not known if retinal abnormalities can begin earlier in treatment.  The rate of progression of retinal abnormalities, the best method of detection of these abnormalities, and the optimal frequency of periodic ophthalmologic monitoring are also unknown.
  • Approximately one-third of patients who had eye examinations have been found to have retinal pigment changes and approximately one-third of these patients had no skin discoloration.
  • Report adverse events involving Potiga to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Data Summary

To date, the retinal abnormalities and skin discoloration observed with Potiga have been reported only in patients who were originally enrolled in Potiga clinical trials, and who have generally taken the drug for a long period of time in two ongoing extension studies (extensions of the clinical trials; 555 patients) and an ongoing compassionate use study (50 patients).  Of the patients in the extension studies, 272 have received treatment for at least two years, and 212 patients have received treatment for at least three years.

The skin discoloration has generally occurred after long treatment intervals (mean: 4.04 years; median: 4.1 years; range: 0.8 to 7 years).  All but two patients were exposed for a period of two years or longer.  As of April 23, 2013, 38 patients had developed skin discoloration out of the estimated 605 patients (6.3%). All patients, however, have not yet been examined.  Of the 38 patients reported to have skin discoloration, 36 were treated with the drug for at least two years.

Of 89 patients still remaining in the ongoing studies, 36 had eye examinations that included a funduscopic and corrected visual acuity examination. It is not yet known how many of these 36 patients also had skin discoloration. Eleven of the 36 patients have been found to have retinal pigmentary abnormalities. Four of the 11 patients did not have skin discoloration at the time of exam. Five patients had worse than 20/20 visual acuity. One of these patients had visual acuity of 20/160 in one eye, while the remaining four had visual acuity of 20/25 to 20/40 in one or both eyes. No baseline visual acuity assessment is available for these patients.

One of the 11 patients with retinal pigmentary abnormalities had a full panel of diagnostic retinal studies, which revealed findings consistent with a retinal dystrophy.  In this patient, mild reduction of visual acuity was noted (20/25), and additional visual testing indicated abnormal electroretinography (ERG), bone spicule pattern on funduscopic exam, perivascular hyperfluorescence on fluorescein angiography, and decreased sensitivity on visual field testing.  In the other ten patients, complete data on retinal function have not yet been reported.

Information on the consequences, reversibility, time to onset, and pathophysiology of the retinal and skin abnormalities remains incomplete. Ophthalmologic and skin examinations on other patients exposed to Potiga in the studies previously discussed have been requested and will be reviewed.

The possibility of more extensive systemic involvement has not been excluded.

Photos

 

Discoloration of lips

 

Discoloration of nails

GSK’s Epilepsy Drug, Retigabine (Ezogabine/Trobalt/Potiga) To Be Restricted Due To Strange Side Effect


Yet another GSK success story…

http://www.reuters.com/article/2013/05/31/us-glaxosmithkline-trobalt-idUSBRE94U0EP20130531

EU agency calls for curbs on GSK, Valeant epilepsy drug

LONDON | Fri May 31, 2013 5:47am EDT

(Reuters) – Use of an epilepsy drug developed by GlaxoSmithKline and Valeant Pharmaceuticals should be restricted to patients for whom other anti-epileptic medicines have proved inadequate or not tolerated, EU regulators said on Friday.

The European Medicines Agency said the move followed cases of abnormal coloring of the skin, nails, lips and eye tissues, including the retina, in some patients who took Trobalt.

It recommended a comprehensive eye examination should be performed at the start of treatment and at least every six months during treatment. Among 55 patients receiving Trobalt in long-term studies examined so far, 15 had retinal pigmentation, the agency added.

Abnormal coloring of the retina can result in impaired vision.

The Food and Drug Administration issued a similar warning about the drug – which is sold in the United States as Potiga – last month.

(Reporting by Ben Hirschler)