Category: seroxat

Stewart Dolin’s Doctor Says (about Paxil) : ““I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”…


And why would he?

Why would anybody trust GSK? Would you trust a felon?

The Dolin trial opened a can of worms about Paxil/Seroxat, suicidality and akathisia which GSK would rather remained tightly in the can. It’s too late now though, the worms are already out…

See Dr. David Healy’s excellent new post about wider implications of the Stewart Dolin Paxil induced suicide trial.


“……The regulatory history of Paxil and the other SSRI’s was almost Byzantine.   For years they carried no warnings of a risk for suicide.  In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents.  A number of medical experts felt the warning should apply with equal urgency to adults.

However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new.  This was the “24 and under” label attached to both brand-name and generic Paxil in 2010.  This suited GSK just fine.  The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.

More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product.  In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide.  The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty…..”


https://davidhealy.org/change-in-chicago-dr-welby-on-the-witness-stand/

Change in Chicago:  Dr. Welby on the Witness Stand

May, 15, 2017 | 8 Comments

Chris Cornell’s Wife Issues Statement, Blames Anxiety Medicine for Suicide


Interesting article about the death of Soundgarden lead singer, Chris Cornell. I loved Soundgarden when I was a teenager. RIP Chris,

http://www.rollingstone.com/music/news/chris-cornells-wife-issues-statement-w483179

 

Statement, Blames Anxiety Medicine for Suicide

“When we spoke after the show, I noticed he was slurring his words,” Vicky Cornell says. “He was different”

Vicky Cornell, the wife of Soundgarden singer Chris Cornell, issued a statement Friday morning where she remembered her late husband, who died Thursday morning at the age of 52, and speculated whether his suicide was the result of taking too much of his anxiety medication.

“Chris’s death is a loss that escapes words and has created an emptiness in my heart that will never be filled. As everyone who knew him commented, Chris was a devoted father and husband. He was my best friend,” Vicky wrote.

“His world revolved around his family first and, of course, his music second. He flew home for Mother’s Day to spend time with our family. He flew out mid-day Wednesday, the day of the show, after spending time with the children. When we spoke before the show, we discussed plans for a vacation over Memorial Day and other things we wanted to do.”

However, following Soundgarden’s concert Wednesday night, Vicky noticed a change in her husband’s demeanor when they talked on the phone after the show.

“When we spoke after the show, I noticed he was slurring his words; he was different. When he told me he may have taken an extra Ativan or two, I contacted security and asked that they check on him,” she continued. “What happened is inexplicable and I am hopeful that further medical reports will provide additional details. I know that he loved our children and he would not hurt them by intentionally taking his own life.”

An attorney for the Cornell family, Kirk Pasich, reiterated Vicky’s belief that an extra dosage of Ativan, an anxiety medication often employed by recovering addicts, altered Chris Cornell’s mental faculties after the Detroit show. Pasich added that the Cornell family is “disturbed at inferences that Chris knowingly and intentionally took his life.”

“Without the results of toxicology tests, we do not know what was going on with Chris — or if any substances contributed to his demise,” Pasich said. “Chris, a recovering addict, had a prescription for Ativan and may have taken more Ativan than recommended dosages. The family believes that if Chris took his life, he did not know what he was doing, and that drugs or other substances may have affected his actions.”

Pasich added that side effects of Ativan include “paranoid or suicidal thoughts, slurred speech and impaired judgment”; Vicky Cornell noted her husband’s slurred speech following the Detroit concert in her statement.

She added, “The outpouring of love and support from his fans, friends and family means so much more to us than anyone can know. Thank you for that, and for understanding how difficult this is for us.”

Hours after Cornell’s death at a Detroit hotel, a medical examiner’s report confirmed that the singer had died by suicide.

Chris Cornell, lead singer for Soundgarden, has died at age 52. Watch here.

Professor John Reed: “Psychiatry sold its soul to the pharmaceutical industry”..


Just wanted to highlight James Moore‘s excellent Podcast series about psychiatric drug withdrawal and related issues.

Check them out on Youtube, below is an interview with Prof. John Reed and his views on psychiatric drugs and the pharmaceutical industry.

Another Seroxat Horror Story..


For the full story see link:

http://vox.gi/cms/local/10831-psychology-vs-psychiatry-what-can-happen-if-the-system-fails.html

“… This sense of inundation and doom moved me to see a GP. It is to be noted that this GP did not even refer me to the mental health team, but rather took it up himself to prescribe a drug called Seroxat. As we tend to do, I put my trust in a medical professional, and took the drug. After a couple of months, I went back and told this same GP that I felt like I was losing touch with reality because I was finding it increasingly hard to focus or control my behaviour, so he doubled the dose.

The result was my first psychotic episode that saw me run away, spend 24 hours walking around Gatwick Airport booking flights and not getting on them, and eventually being escorted out of the departure lounge. I was taken to see a psychiatrist in London who mistakenly diagnosed me with bipolar disorder based on those symptoms he was seeing.

Those were not symptoms of “ME”; they were a horrific side effect of Seroxat. Had I just been taken off that drug at this point, this is where the story would end. I was taken off it, but it was replaced with Lithium and Lamictal, drugs to treat bipolar disorder. As hard as it is to believe, I then spent about ten years continuing to have psychotic episodes and mood swings, which were taken by psychiatrists to be further evidence of my diagnosis, and having doses not only increased but, as the years went by and still having pschotic episodes, the drugs changed for others to find the ones that would work.

None worked. Why? Because the drugs were the problem; the drugs themselves, in my case, were triggering the psychotic episodes the whole time. I spent ten years, however, convinced I had bipolar disorder because the psychiatrists said so, and believed I must have such a severe case that, despite drugs, I was still having episodes. It was not until four years ago, having lost my 20s to chaos, that I became totally desperate and pleaded at a local psychiatrist to help me because I was at the end of my rope. The initial point of my visit was to say if the drugs aren’t working then please just take me off them. Little did I know that this is what I should have done years earlier. Had she taken this course of action, because ultimately it was up to me whether or not I took those drugs, the end result would have been the same and a shock: I am way better now without them. But this psychiatrist actually spent about two hours looking over my entire case history and asked me the only question no other psychiatrist had thought to ask me the entire time: “Had you ever had a psychotic episode before being put on any of these drugs?” And of course the answer was no…..”

Why Is Greg Thorpe The Only GSK Whistle-Blower Willing To Speak The Truth About GSK’s 3 Billion Quid Pro Quo (Sham-Fine) With The US Department Of Justice?…


Greg Thorpe originally blew the whistle on GSK’s fraudulent activity- and it was as a direct result of Greg’s actions- that GSK were fined 3 Billion in 2012 by the department of Justice. Greg regularly leaves comments on this blog, and they are always extremely interesting, particularly in relation to the department of Justice- GSK fine -debacle.

I call this scandal a debacle because I have long thought that GSK’s fine of 3 billion, and the corporate integrity agreement etc, was merely a little slap on the wrist for GSK. People died because of GSK’s various unethical shenanigans; crimes committed by GSK over many years: many patients were harmed, maimed or killed. GSK should have had its license to trade revoked, instead the department of Justice fined them 3 months profits and allowed to them continue on -business as usual. The executives all sailed off into the sunset, dripping with even more wealth and money than they had previously earned – golden parachutes all-round for the GSK top brass-despite being party to the biggest health care fraud of the 21st century.

Astounding isn’t it?

I’ve always felt that the whole thing stank to high heaven, and furthermore, I have always wondered, why is Greg the only whistle-blower willing to tell the truth about this sham fine?

There were, apparently, another 5 whistle-blowers- why do they not speak out about the quid pro quo? Why do they not criticize Eric Holder and the revolving door? Why do they not speak out about this grave travesty of justice to consumers and patients? Why do they not speak about this slap on the wrist for GSK? Why do they not tell the public that far from being a success for patients, this fine was merely a sleight of hand and a smokescreen?- as GSK were allowed to continue on- as evident by their China-Bribe scandal in 214, to commit more bribery and fraud in different countries, further afield.

Why do they not inform the public about the real scandals of this debacle?

Thankfully, we have people like Greg, he’s not afraid to speak out- here is his latest comment-

https://truthman30.wordpress.com/2017/05/12/interesting-comment-by-whistle-blower-greg-thorpe-about-gsks-lamictal-scandal/#comments

May 13, 2017 – 3:58 pm High Plains Drifter

There are hundreds if not thousands in the DOJ that are to say the least, are not interested in real justice or the truth. They are not in lockstep with Jeff Sessions to say the least. They regularly monitor this site. Truthman knows this. I hate to coin a phrase, but this swamp cannot be fully drained.

I have been threatened and put myself at risk with everything I say…they violated my constitutional rights by putting a gag order on me for 9 1/2 years…so GSK could continue to reap off label marketing profits and worst of all patients and physicians were kept in the dark. The law I filed under, the False Claims Act has no provision for this conduct, for such a length of time. They are allowed to seal the case only to investigate whether it has merit. I was interviewed under oath by the FBI…3 months after I filed. every government agency was present who had a stake in the case…DEA, HHS, FDA, DOD, IRS, CIA, VA ,DOJ, FBI and others…Shortly after that, I was informed through Counsel that DOJ had dozens of people on the case, and a entire floor at DOJ working on the case. I assume this was true. The False Claims Act seal is to only be extended after they decide to take the case, usually 6 months, for good cause. Obviously it became apparent after 9 years that the seal only remained in place so DOJ could secretly, without public knowledge cut a deal with GSK or go to trial. During this long, long period of time, I was never told that they had joined my complaint until the 11th hour AFTER the settlement was reached. They used this tactic to threaten me with non joining and tossing me out for 9 years plus. During this time, patients continued to receive prescriptions on the 9 drugs I reported …physicians were kept in the dark. In short, the carnage continued…I consistently objected but to no avail. The lead prosecutor told me after I demanded that this go to trial that they “would bankrupt the company, and nobody would get anything”…at the time I thought the statement may have merit, although I now know it was sheer B.S. It would be hard to bankrupt a company with a market cap approaching 200 billion dollars or more.. So I kept my mouth shut while people died, and that haunts me to this day. It included my mother who developed congestive heart failure while kept on Avandia, for diabetes. I did not know GSK had hidden data showing it caused CHF, until it was too late. Hundreds of thousands of patients suffered the same effect, and this was going on with all the drugs reported…but did the DOJ care. Hell no they kept all of this important data sealed from patients and physicians. Why ?

The only reason I know now was to negotiate a sweetheart deal for GSK under a former attorney for the company….ERIC HOLDER. Holder was supposed to have recused himself. I have no evidence that he did. I BELIEVE after he gave GSK the quid pro quo for his law firm, Covington Burling….IN A FINE THAT AMOUNTED TO 3 MONTHS OF COMPANY PROFIT..that he had his hand on the trigger. Supporting this is the fact that he returned to Covington Burling to what has been reported as a “hero’s welcome and a huge raise”.They were even nice enough to give him his old office back, supposedly saved for his return. Holder committed many acts as Attorney General which warrant investigation …but none of this caliber.
GSK lost 3 billion dollars…one month of profit. Nobody was prosecuted .
Nine and one half YEARS is a long time…especially to rob the taxpayers who fund these illegal prescriptions of 40-50 billion dollars, at least. This would not even be what the punishment calls for under the statute. People should be in prison and maybe the company should be bankrupt…they continued the crimes all over the world after the settlement, while under 3 corporate integrity agreements, which called for the so called “death penalty” meaning no Federal program Medicare, Medicaid, VA, etc could use ANY GSK drug..

Why? It defies anything I can come up with except massive criminal fraud and corruption at the highest levels of government. This is a huge story, what I saw and heard over ten years makes me literally sick…yet Nobody seemingly will say anything…the other , second to file whistleblowers, were a joke…copied my complaint, took their money and hid . Mere accomplices to the crimes in my opinion.

Do I fear retaliation for what I say…hell yes I do, but someone has to speak up on this.

I am hopeful someone in the DOJ will come forward, everyone cannot be corrupt or cowardly and I hope we will see under a new administration, something done.
As to the post about Jeff Sessions.. the answer is I don’t know what he can or will do. All I know is my son was in second grade when this began , now he is about to graduate from college. This hasn’t been easy for my family or me and I’m not sure if the swamp can ever be drained. I know a lot more, but someone in the DOJ has inside information…I hope they come forward. The lead investigator, Sara Bloom …would be a good start.

Interesting Comment By Whistle-Blower Greg Thorpe About GSK’s Lamictal Scandal..


“…Sir Andrew Witty, GSK’s chief executive, said the settlement brought a resolution to “difficult, long-standing matters for GSK” adding: “I want to express our regret and reiterate that we have learned from the mistakes we made.”

Critics point out that other executives directly named as having been told of concerns continue in top jobs, albeit in different companies.

Whistleblower Greg Thorpe first alerted the company to the entertainment offered to doctors and the culture that allegedly put profits above ethics in 2001. He raised his concerns with David Stout, who was then head of the US business, and Bob Ingram, GSK’s chief operating officer. When he was forced out of the company, he took his case to the regulators, which spent almost 10 years investigating the issues….”

“…..Eliot Spitzer, who as New York’s attorney general sued GSK over similar allegations eight years ago, told the New York Times that companies like GSK seem incorrigible. “What we are learning is that money [ie fines] do not deter corporate malfeasance. The only thing that will work in my view is chief executive officers and officials being forced to resign and individual culpability being enforced…….”

https://www.theguardian.com/business/2012/jul/08/pharma-misbehaviour-gsk-fine

The Guardian 2012




GSK whistle-blower Greg Thorpe left a really interesting comment on my blog – in relation to GSK’s Lamictal. Lamictal was one of the drugs mentioned in the US department of justice complaint- which eventually led to GSK’s 3 billion dollar fine in 2012. It was because of Greg’s bravery and tenacity that this fine came to fruition and GSK’s vast off label fraud and criminality was exposed to the world, however, as Greg has stated multiple times- the fine itself was paltry, as was the final settlement. It was not justice for patients nor was it adequate punishment for GSK. The CEO’s and top executives did not receive fines or jail time, in fact many of them were made multi-millionaires and now live in luxury, despite the fact that they were part of a massive fraud and bribery network which led directly to deaths and harm to tens of thousands of innocent trusting patients and consumers (as illustrated in the Dept of Justice complaint).

One such executive now living the high life off the backs of many years of GSK’s various unethical shenanigans is Bob Ingram. Bob Ingram was the US head of GSK for many years leading up to GSK’s 3 Billion felony crimes. Bob now enjoys showing off his Porshe collection all around the US. He’s probably worth tens of millions, and perhaps never gives a second thought to kids killed on Paxil, or any other folks harmed by GSK’s greed over the years?

Anyhow, here’s Bob talking about his Porshe collection..

Here’s Greg’s comment:

https://truthman30.wordpress.com/2017/05/11/woman-sues-gsk-for-horrific-lamictal-side-effect/

“….GSK DID NOT pay 3 billion dollars for Lamictal crimes…little to nothing was paid for Lamictal relative to the settlement…in spite of the fact that it was actively marketed for depression and bipolar disorders at least 6 years before any type of approval. This was a large part of the DOJ complaint I filed in 2003. In fact one woman died after treatment of her depression with Lamictal. It was reported to GSK and they covered it up. I reported this murder to DOJ in my complaint, it was ignored. GSK made hundreds of millions of off label dollars with this dangerous drug for years. There SHOULD HAVE BEEN AT LEAST a 3 billion dollar drug alone in fines and executives were informed, look up the Thorpe v GSK complaint. Career prosecutors under Eric Holder, former attorney for the company who Said he recused himself ….huh? allowed this quid pro quo to happen under corrupt career prosecutors…want names..Ask Jeff Sessions .
The taxpayers were robbed of Tens of billions of dollars by the Department of Injustice who took ten years to ruin my complaint…to give GSK a free pass=1 month of GSK profit.

This death occurred where I worked, they did nothing. Holder and his crew of career idiots and political hacks should be in jail, right along with Bob Ingram ,

JP Garnier, and all the planners and initiators of the fraud.
It is the most horrible, disgusting violation of everything proper, that should have concluded a 10 year investigation. It makes the current Russian scam a walk in the park.

I still cannot believe how bad and evil these deep state bastards in the DOJ
gave this free pass to what I reported.
Now Bob Ingram r, former CEO, COO, rides around in his choice of dozens of Porsches, that run on the blood of dead or maimed patients. Who will come forward at the DOJ ?
We’ll see….”

 

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

Woman Sues GSK For Horrific Lamictal Side Effect….


Khalia Shaw‘s skin was burned from inside out after dosage error. Picture: Journey of a Butterfly

Fox News

A GEORGIA woman who is three years into a painful recovery is suing after claiming she received the wrong dosage of a medication that caused her body to burn from the inside out. Khaliah Shaw, 26, spent three weeks in a medically induced coma while her skin slowly peeled off and wants to ensure that other patients are protected from pharmaceutical errors, 11Alive.com reported.

“This did not have to happen,” Ms Shaw, who lives in Snellville, northeast of Atlanta, told 11Alive.com. “This was not just some sort of fluke in my opinion. This happened as a directly (sic) result of somebody’s error.”

In 2014, Ms Shaw told her doctors she felt depressed and received a prescription for Lamictal, an anti-seizure medication sometimes used to treat bipolar disorders, the Tech Times reported.

Ms Shaw took the medication for two weeks before she started breaking out in blisters. Ms Shaw told the news outlet that her body felt like it “was on fire”.

Eventually, doctors diagnosed her with Stevens Johnson Syndrome, a rare skin disorder that is typically caused by an adverse reaction to medication, 11Alive.com reported.

“It essentially causes your body to burn from the inside out, and you pretty much just melt,” she told 11Alive.com.

Khalia Shaw was diagnosed with Stevens Johnson Syndrome. Picture: Journey of a Butterfly

Khalia Shaw was diagnosed with Stevens Johnson Syndrome. Picture: Journey of a ButterflySource:Supplied

 

The Palm Beach Post reported that others are also suing pharmaceutical company GlaxoSmithKline (GSK) for promoting Lamictal without advertising its risks in full. In July 2012, the pharmaceutical company pleaded guilty to criminal negligent charges for allegations of fraud and failure to report product safety data for the drug, the newspaper reported. GSK paid $3 billion total.

As for Ms Shaw, the young woman has come to resemble a burn victim. She has lost her fingernails and sweat glands, and she is slowly going blind, 11Alive.com reported.

“They’re telling me this could happen again, and they’re telling me if it did happen again, that it would be worse,” Ms Shaw told the news outlet.

The lawsuit claims her medical bills total upwards of $3.45 million and are expected to continue to grow as she continues receiving treatment.

“I never heard of Steven Johnson Syndrome until I was in the hospital with my skin melting off my body. That’s when I learned what it was,” she told the news outlet.

Ms Shaw’s lawyer told 11Alive.com that alleged errors by pharmacists continue to “happen at an alarming rate,” because staff are too rushed and too busy.

In telling her story, Ms Shaw wants to raise awareness about the dangers of prescription medication errors.

“It is difficult being in the spotlight, but I think it is worth it if it means someone is more educated about the medication that they are taking,” Shaw told The Palm Beach Post.

This article originally appeared on Fox News.