Search Results for: UK

The independentThe Lariam Scandal: Former head of army calls for ban on malaria drug
The Independent  (UK), Friday 27 September 2013

 

Effectiveness of malaria chemoprophylaxis against P.falciparum infection in UK travellers: Retrospective observational data. Zuckerman, Batty, Jones. Travel Med and Infectious Disease, Sept 2009.

bbc-blocks-dark[8/17/15 Today Programme] Call for Army to stop using malaria drug Mefloquine
By Sima Kotecha Today programme

BBC Radio 4BBC Radio 4 – The Lariam Legacy [3/31/2015 26 Minutes] An investigation into why the Ministry of Defence continues to use a drug that has been shown to cause psychosis, hallucinations, paranoia and confusion. Check BBC Website for alternate dates.

The independentHe told me of his Lariam dreams – then killed himself: The human cost of the UK’s suicide drug scandal. The Independent (UK), Jonathan Owen, Monday 07 October 2013

Neuropsychiatric Side Effects Confirmed by Latest Lariam Research

FOR IMMEDIATE RELEASE
Contact Jeanne Lese
February 2001

SAN RAFAEL, CA Five new studies, including a randomized, double-blind clinical trial, find significant scientific basis for the growing concern over side effects of mefloquine (Lariam®). Lariam is an FDA-approved antimalarial prescription drug from Hoffmann-La Roche. Four studies from the Netherlands, Sweden, Spain, and California find that Lariam causes significantly higher number of central nervous system and neuropsychiatric adverse events than other antimalarial drugs, especially when compared to its newest competitor Malarone® (atovaquone/proguanil). Roche defines “central nervous system” symptoms as “convulsions, depression, hallucinations, psychotic or paranoid reactions, anxiety, agitation, aggression, confusion, forgetfulness, hearing impairment, restlessness, sensory and motor neuropathies (including paresthesia), tinnitus and vestibular disorders, visual disturbances. Suicidal ideation has also been reported.” (Lariam Product Information, 1999). [emphasis added throughout]

The Studies

The randomized, double blind clinical trial from the Netherlands found that Lariam causes twice as many neuropsychiatric adverse reactions as Malarone:

Subjects receiving Malarone had a lower rate of treatment-related neuropsychiatric AEs [adverse events] compared to MFQ [mefloquine] (14% vs. 29%).” (D Overbosch et al., presented at the 40th annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, 19 Sept. 2000.)

California researchers found that one in five people taking Lariam experience side effects severe enough to make them stop taking the drug and, as a consequence, increasing their risk of illness:

“Data herein indicates 1 in 5 individuals prescribed mefloquine reported adverse events with significant rate of therapy discontinuation, placing the traveler at risk of contracting malaria.” (B Ward and D Mathison, Scripps Clinic Travel Clinic, June 1999.)

The Denmark study focused on central nervous system side effects from Lariam and two other antimalarial drugs, finding that:

“…symptoms related to the central nervous system are more prevalent in mefloquine users and when symptoms develop, they are perceived as more severe.” (E Peterson et al., Journal of Travel Medicine, March 2000; 7:79-84)

CDC changes advice, manufacturer revises Lariam information

Recent action by the Centers for Disease Control (CDC) and Lariam’s manufacturer flags the importance of these five new research studies.

On February 1, 2001 the CDC changed the advice it gives travelers about the drugs recommended for malaria prevention: “Alternatives for travelers who cannot or choose not to take mefloquine include doxycycline or Malarone(TM).” Previously Lariam was the CDC’s “drug of choice” for malaria prevention.

In August 1999 Hoffmann-La Roche massively expanded the Lariam product information sheet (“PI”). Additions to the PI include:

  • more contraindications about who should NOT take Lariam,
  • a more extensive listing of reported physical and neuropsychiatric adverse events,
  • first-time warnings of reports of central and peripheral nervous system disorders (e.g. loss of balance and other balance-related problems),
  • an entire new section of information for patients, and
  • new cautions about prescribing Lariam for children.

Furthermore, the PI acknowledges for the first time that “because of the long half-life of mefloquine, adverse reactions to Lariam may occur or persist up to several weeks after the last dose.” It was previously thought that Lariam’s side effects could only occur during the course of treatment or immediately thereafter. The manufacturer has not yet defined the exact duration of “several weeks.” Accumulating anecdotal evidence indicates that symptoms of Lariam toxicity can persist for years after the drug is discontinued.

Roche did not issue a “Dear Doctor” letter when the company revamped the Lariam PI. Without an official alert, physicians are likely to miss the changes. Roche similarly delayed notifying physicians of reports of serious depression and suicide involving its acne drug Accutane (a registered trademark). (Lariam can also cause depression and suicide). Only after Congressional pressure from Michigan Congressman Bart Stupak did Roche send a Dear Doctor letter about Accutane. The Congressman’s son BJ committed suicide while being treated with the acne drug.

Inadequate warnings about Lariam’s possible dangers

Most patients receive inadequate warnings about Lariam’s side effects. Product Information sheets are written for doctors. The only warnings the patient may receive will come from the prescribing physician and/or the pharmacy that fills the prescription. US health officials seriously underestimate the severity of Lariam’s side effects.

Lariam Action USA

Lariam Action USA is an information and support service. Travelers need to know ALL the risks and benefits of any antimalarial drug BEFORE they can make an informed decision about which one to take. More than 1,000 people have voluntarily reported significant Lariam side effects to us since 1997. There are Lariam interest groups in the US, UK, Canada, Denmark, Ireland, New Zealand, and Switzerland. New groups are expected soon in Australia and France.

– 30 –

Please contact Lariam Action USA at:

Lariam Action USA
64 El Pavo Real Circle
San Rafael, CA 94903-3521

info@lariaminfo.org

LARIAM: THE STORY IN THE UK

Lariam (also known as mefloquine) was licensed for use in the UK in 1990. In 1993, it became the main prophylaxis (ie. preventive drug) for people travelling to areas known to be resistant to chloroquine, including parts of Africa. Since then, the guidelines on its use have been revised several times (see below).

Why isn’t there a Lariam Action in the UK?

Since the mid-1990s there has been public concern in the UK about the possible side effects of the drug. A self-help support group, Lariam Action, was set up in 1995, but is now disbanded.

After television publicity on the BBC consumer programme ‘Watchdog’ on 6th November 1995, and subsequent press reports, nearly 1000 people contacted the Bristol-based solicitors Lawrence Tucketts thinking they had a case against Roche. Some of them were actively involved in Lariam Action.

Some had lost jobs, some were sectioned under the Mental Health Act, others were unable to work for years or more because of the physical and medical legacy, which they believe was a side effect of taking the drug.

Of the 1000 cases, lawyers decided 200 looked convincing enough to use in a court case against Roche. 70 of them were funded publicly through Legal Aid. When, in 1998 and after lengthy legal arguments (see below), Legal Aid was withdrawn, the legal action collapsed. Private clients, who were footing their own bills, had no choice but to pull out.

Roche didn’t actually win, as such, but it did strike a deal preventing those who had pursued the case from taking any further action against the company. Providing they did not pursue any further publicity against Roche, the company would not pursue the applicants for the costs of the case.

Lariam Action UK – led by Lorraine Traer-Clarke and Lance Cole – disbanded the same year, feeling they had taken the case as far as they could.

Why did the Legal Aid Board withdraw funding?

Lawyers had advised the Legal Aid Board, who decided on funding, that the chances of success were slim. The claimants would have had to show that Roche had failed to reveal all the information it had about the drug’s safety, that patients would not have taken the drug had they known of the side effects, and to prove the side effects were higher than those claimed by Roche.

What has happened since then?

Following the adverse publicity, UK experts have revised the advice on malaria prophylaxis several times, in 1997, 2001 and 2003.

In September 1997, the government’s Malaria Advisory Committee issued complex 16 page guidelines, fine-tuning Lariam’s use to certain parts of affected countries at particular times of year.

The gist of the changes was that travellers to East Africa for two-week package holidays, who were at a lower risk, should use chloroquine and proguanil.

Those travelling to West Africa, where the risk was considerably higher, should still use Lariam in June to December, when the transmission risk was at its peak. The rest of the year they could use chloroquine and proguanil.

Since then, the guidelines have been updated and revised again, once in 2001, and again in 2003. (Current guidelines)

The guidelines acknowledge that neuro-psychological effects are more likely in women than men.

They also spell out the alternative drug options currently available for malaria prophylaxis in the UK. These are doxycycline, Maloprim, and Malarone, as well as the more traditional chloroquine and proguanil. The guidelines are complicated: you are advised to seek the advice of a qualified doctor if you are in any doubt as to which is appropriate for your particular journey.

I think I suffered adverse reactions from Lariam, what can I do?

If you have suffered an adverse reaction which you think is due to taking Lariam, then please inform your doctor and ask them to fill in a Yellow Card reporting your fears to the Committee on Safety of Medicines. Only by doing this will your concerns be registered with the authorities who monitor drug safety.

You can find out more about the scheme look up ‘Yellow Card’ in the search engine at Medicines and Healthcare products Regulatory Agency.

Can I pursue legal action despite the collapse of the previous case?

The chances of getting public funding for a case against Roche are slim. But you may wish to check with AVMA for further advice about what you might do.

More Tips

Advice from the Mailing List

You are not going crazy. Your brain has been damaged by Lariam and its effects are cyclical and unpredictable; however, in time, you will get better.

I have become very withdrawn, finding crowed places too noisy

Much like you, I, too, cannot endure large crowds. Everything is reduced to a cacophonous babble that I cannot understand. It is opined that Lariam has stripped the myelin sheaths from the neurons in our brain, leaving us unable to filter out the billions of stimuli that bombard us every second of every day; stimuli that the normal brain can selectively filter out. E.g., strobe lights of any kind (to include the flash components of digital cameras) completely and totally shut down my brain and leave me unable to function at all. When I attend functions or events that involve large crowds, I always carry very dark sunglasses and special, sound-filter earplugs that allow me to hear the full range of sounds but reduce the volume to compensate for my brains deficiency.

[I] had a MRI yesterday under neurologist supervision but seems I should get some “balance system” tests done, which I will discuss with him when I go for my results.

Please do not be saddened at the results of these tests, especially when the doctor says that they’re normal and nothing wrong can be determined. Lariam’s damage to the brain is not revealed by such tests. However, I encourage you to undergo them anyway, just to reassure you that you are a healthy, vibrant person aside from the damage that Lariam has done to your brain. All of us have experienced doctors who observe our symptoms and then attempt to categorize them within the limits of their specialty. “Oh, your vertigo is definitely being caused by an anomalous problem within your inner ear, but the tests I performed cannot substantiate it for some reason.” When you then suggest to your doctor that, since all such anomalous inner-ear problems manifest themselves in a specific part of the brain, and, just perhaps, it is that part of your brain that is damaged, he then dismisses you with some snide remarks that indicate that you, the patient, could never know as much as he about such symptoms. Jill, we’ve all been there and have endured such frustrations at the hands of physicians of every specialty who just do not know enough about the brain to treat our problems.

Last week I suffered another serious vertigo episode that hospitalized me for a few hours one afternoon. The ambulance crew administered Zofran to ease my severe nausea and vomiting, and the ER doctor gave me a prescription for the same medicine. It really did ease my vertigo and helped me get on with my day. While I loathe the idea of consuming any chemicals whatsoever, I have always been an advocate for taking those medications that are necessary to bring my brain chemistry to a state of harmony. I’ve said it before on this site: when the brain’s 3 main chemicals – serotonin, dopamine and norepinephrine – are out of sync, it’s like one of the 3 tenors singing off key. It’s vital to your health and stability to do what is necessary to return these chemicals to a state of harmony before life can go on normally.

Can anyone please tell me now long I can expect these symptoms to last? How long does it take the brain to retrain itself and can it do this without treatment?

Unfortunately, Jill, there is no answer to those questions. However, I PROMISE you that you will get better over time. Treatment is necessary if your brain’s chemistry requires a rebalance. Only you will know how much. If, for example, you require medication to combat acute insomnia, take the medication. I personally believe that acute insomnia is the only life-threatening symptom of Lariam’s multiplicity of damaging effects. In addition to taking Ambien for sleep, I also had to take benzodiazepines for severe anxiety and panic attacks. Fortunately, I was educated about the addictive powers of benzodiazepines and knew that I had to wean myself off of them as soon as possible.

You definitely have been through the worst by now, Jill, and your brain will heal over time. But it is a slow and tedious process that requires patience and practice. Doing anything that maximizes the use of your brain, challenges it and teaches it new things will help over time.

E.g.: If you’re right handed, learn to become completely ambidextrous. Try studying a new language. Take up golf. But only do such things if they can be done in a positive manner. The first and most important challenge is to teach yourself once again how to be positive and happy in light of the brain damage that is now part of your life. That, too, can only be achieved with practice.

All the best,

—Jim (Lariam, ’00)

I took Lariam for seven weeks in 1995 and suffered an acute anxiety reaction including hyperventilation for about six months. Once this initial reaction had subsided I thought that the drug was completely out of my system and I could just put my problems down to experience and forget about it. However, for the next ten years I found that in certain situations my anxiety levels were greatly increased to a point that was terrifying and debilitating – mainly in certain social and performance situations (and in particular when I had to give a talk or presentation). I couldn’t understand why I was going through this, but never thought that it was to do with Lariam, because I believed that I had got over the effect of the drug.

In 2006 my problems with panic came to a point where I had to seek medical help. I was also suffering from severe abdominal pains, which I now believe are the result of a slightly malfunctioning nervous system (I have had numerous abdominal tests which have given me the all clear). Thankfully my doctor (or general practitioner as we call them here in the UK) was reasonably sympathetic and referred me to the London Hospital for Tropical Diseases, where a specialist (who actually thinks very highly of Lariam) acknowledged in writing that it is likely that I have been affected by this drug in the long-term.

I am not writing this to depress you, but to say that this “acknowledgment” that I “most probably” have been affected by Lariam is a source of great comfort to me, and it helps me in my dealings with my employer, who, as it happens, is also reasonably sympathetic.

The long-term problems come and go, and therefore, as others have written, are cyclical. At the moment I feel I am going through an easier part of the cycle. Life is made easier when you recognise how Lariam has affected your nervous system, and you acknowledge your limitations and learn to live within those limitations. It is a kind of disability that one has to work round.

I believe that Lariam has caused damage to some part of my brain stem with the result that nervous reactions are not synchronised as smoothly as they ought to be. It is analogous to the gears in the gear box of a car not engaging smoothly as you speed up and slow down – major changes in levels of activity can cause panic reactions (“the crunching and slipping of the gears”). So, for example, in situations where I need to be alert and focused (such as in giving a speech) I find that my nervous system does not cooperate – the correct neurotransmitter does not seem to “kick in” at the right time, as it used to in my pre-Lariam days. I can’t get into the right frame of mind, and so I panic. Once I succeed in getting “into gear” I am then fine.

I think that once we know what is wrong with us then the long-term problems can be managed, and from my experience I believe that life does get easier. The most important thing is to not be fobbed off by ignorant and complacent medics. There is so much evidence on the internet about the effects of Lariam, that there is no excuse for this kind of behaviour.

I hope my thoughts help, and most of all I wish you a speedy recovery.

—Allistair, UK

“In My Own Words”

Lariam Sufferers Describe Their Experiences

“After taking Lariam … I [developed] rapid heartbeat, paranoia, and panic.
I have since had episodes of severe panic, depression, sleep disturbances, shaking, flushing and feeling of foreboding …
This is by far the worst thing that has ever happened to me.
The psychotic episodes were nearly unbearable.”

“I know of one Marine … that committed suicide while we were in Mogadishu. I also know that there was another Marine [in Mogadishu] who had to be treated for a Lariam freakout … As for Me well … suicidal ideations … yes … never attempted it though. … the funny thing is we all had these symptoms in Somalia, as a matter of fact we joked about the rampant insanity that everyone seemed to be experiencing.”

“I was not warned of the dangerous side effects … ended up in a mental hospital by the end of the trip because no one could explain my manic behavior. My brother flew down from the States to get me because I called home several times stating that my boyfriend was trying to drug me and kill me.”

“Very ill since my first week of Lariam … been from doctor to doctor … after numerous blood tests, they find nothing wrong! … very frustrating and confusing … began to think that maybe nothing was wrong and that all my symptoms (tired and weak, nausea, headaches, dizziness, mood swings, insomnia, shortness of breath, rapid heartbeats) were psychological. I have been off of Lariam for almost 4 months now and just when I think the symptoms are getting better I will have a day when I am feeling bad again. What can I do to speed up the process? Is there any drug that will counteract this medicine? How can I make sure that no one else has to go through this?”

“My wife and I had adverse psychiatric reactions to Lariam while serving … in West Africa from 1989 to 1992. It resulted in documented severe depression attacks that lasted until 1996.”

“After having a ‘breakdown’ and panic attacks at work yesterday, and putting lack of concentration and ‘depression’ at work down to post holiday blues, I now realize that I am suffering from the effects of Lariam.”

“I felt my head was leaving my body and I was falling down rapidly into an unknown darkness … I was confused and afraid … [imagined I saw] arrows and other geometrical figures battling with each other … I saw myself looking at my body and I thought I had to throw away that body because it was not useful anymore. On the 16th floor of the hotel in Bangkok, I was afraid to go close to the window. I thought the window would open itself and then I might fly out of the window.”

“I served in Somalia in 1993 for 5 months. I took Lariam once a week for the entire tour. That was 8 years ago. I have been diagnosed with PTSD [Post Traumatic Stress Disorder] by the VA and received 100% disability. I have attempted suicide 10 times and have shot myself twice. I suffer from severe depression. I learned about Lariam on the Internet about 3 years ago but was just too depressed to do anything about it.”

“I went to Africa … in excellent physical condition … suffered intense chest pain on Mount Kilimanjaro … could not move … six porters carried me down the mountain on a stretcher for 6 hours in the dark. I continued having ‘attacks’ that included accelerated heart rate, numbness, tingling sensations in the extremities and face, shortness of breath, and dizziness. I was discharged from the hospital … and was told my heart was fine. Foolishly, I then took another Lariam pill and a few days later suffered another ‘attack.’ I returned to the Nairobi Hospital and was diagnosed with Lariam toxicity. The doctor told me that I would be suffering these ‘attacks’ for a couple more months. In total, I had 3 pills.”

“I am suffering from the harsh side effects of Lariam. …I just search and search for a solution not just for myself but everyone touched by this … I am ashamed to say that I have had to almost hold all my Doctors’ hands through this process to get anything done. My doctor was told by Roche that the side effects should last nine months from the last pill taken. I feel bothered … but I am also vindicated … I feel my Doctors never truly believed me and my Lariam-caused nightmare.”

“After taking my fifth pill (in Africa), muscles in my body began to tingle, grow weak and painful … unlike any common muscle pains … spread to my jaw and was followed a week later by extreme dry mouth and incredible nausea requiring a trip to the emergency room. The nausea, like the muscle weakness and pains, was different from any other illness or injury, however extreme, I had ever felt. All the tests the hospital performed came back normal. The nausea would decline over next 12 hours and then begin to cycle back through again a day later. I was also experiencing extreme anxiety. Although the emotional reaction was not rationally unfounded (foreign country, unprecedented and severe illness) it nevertheless seemed out of my control.”

“…in early December 1992 we took [Lariam] in Somalia. …ironically enough [it]did not prevent me and hundreds of [US military personnel] being diagnosed with malaria … I have … panic, anxiety, depression, migraine and even hallucinations. These were dismissed by [others] … I became more withdrawn and at times quite unstable … led to my separation from my [family] … I get depression and anxiety attacks … severe headaches practically on a daily basis and I never had any history or migraines or other headaches … need to know if my [experience] is similar to others exposed to this drug. It will at least give me some peace of mind.”

“My travel clinic and my doctors told me nothing of the Lariam debate … nor did they encourage me to educat[e] myself regarding this drug. I feel the US is highly undereducated regarding this controversial drug and its potential side effects.”

“I have been a Lariam sufferer for 4 years It has completely ruined all aspects of my life. My social life has been nonexistent, my family life has been affected, my career has been halted, and my mental state has now been affected … I could write a book on [Lariam] and would if I could concentrate for more than a few minutes at a time.”

“I took Lariam in March 22, 1999. On March 26, I had the first attach of acute vertigo with the room spinning and no ability to balance. Lasted two weeks, but I am left with lack of balance, disorientation, and a perception of after motion any time I move my head. Is there any relief from this? Does it go away in time?”

“A complete, do-it-yourself Dr. Jekyll and Mr. Hyde kit, all in five little bitty pills. I have been able to experience just about every psychological problem known to mankind in just three short days.”

“I am a physician who [was] in excellent health [until Lariam] … can’t focus … not sleeping … remain very anxious. My biggest fear is that although the half life is supposed to be 21 days, that it will take considerably longer to get rid of the effects of the drug. … I have this sick sense that this may be a permanent problem. … I feel like my brain … has been fried … have grave concerns that my career is ruined. …was never advised of
side effects … the [Lariam] package insert was not included….”

“Since [taking Lariam ] three years ago, my brain hasn’t worked the
way it used to. It’s as if someone has gone in [to my head] and
rearranged the furniture. I would give anything to feel like I did,
be the person I was, before Lariam.”

“Three years ago I took Lariam for three weeks. The result was immediate psychological terror and a near suicidal experience. I had hives all over my body, hourly temperature fluctuations and hallucinations. I would sit in the
corner of a room, shaking and shivering, and nobody could help me.
I was forced to end my trip early and return to the US,
where NO doctor could assist me.”

“[a physician] took Lariam in November 1995. …after the 4th dose I began to experience adverse reaction … extensive neurologic impairment, severe nausea, vomiting, intermittent fever, chills, insomnia, depression, anxiety, numbness in both lower extremities, no feeling below my knees … that persists to this day … Only after extensive research here [US] and internationally, over $30,000 in medical costs, and numerous talks with tropical medicine experts in the UK, did I realize I was suffering from Lariam toxicity.”

“Within a few days [of taking Lariam] I developed a spot on my cheek … a pea-sized open area that would not heal. …[I developed] more patches, itching, redness … open sores that scabbed over, peeled and bled … The day I left Africa my face was 98% inflamed, with welted circular patches that intensely itched and wept so badly that I carried a towel with me to stop the dripping.”

“After two years … I feel as if I am going to collapse, my legs turn to jelly … feel I’m completely drained of all my energy … that everything around me is about to start spinning … loss of coordination … panic attacks … nausea … broken nights and unsettled sleep … stomach pains … disturbed vision. I am a thirty-year-old male and before [Lariam] I regularly played
rugby and football. [Now] no doctors are able to give me any indication as to
when or if I will ever get better.”

“Violent dreams … every few nights … My friends … were having similar dreams and they’d say, ‘I had another mefloquine dream last night.'”

“I took Lariam three years ago. I have a fever of over 100 degrees while typing this, am incredibly dizzy, my back aches, my eyes spin and are blurry, my ears hurt, my arm and leg hurt, my heart is doing funny things ….”

Lariam product information (Summary of Product Characteristics, SPC) Roche UK, August 2009

“It’s not a benign drug- it has ruined my life” The Guardian, October 24, 2002