Lyrica Once Again Shown To Be Ineffective

Today's post from vancouversun.com (see link below) will come as no surprise to may neuropathy patients who have been both disappointed by the ineffectiveness of pregabalin (Lyrica) and damaged by its side-effects. The fact is that it rarely works for neuropathic pain. However, because of aggressive marketing, it's the world's number one treatment for nerve pain! To be fair to Pfizer, they did withdraw their own recommendation for Lyrica for many disease-related neuropathies in March 2013 but that was forced by litigation and so much protest that it was inevitable. The FDA's warnings about the drug were that last straw. So why is it still so widely prescribed, despite the inherent dangers of side effects? Who knows! Apparently the marketing goes on and unscrupulous drugs company reps will prioritise getting rid of current supplies as quickly as possible. If you are prescribed Lyrica (pregabalin) for your neuropathic symptoms, please have a serious discussion with your doctor and maybe try to arrange an alternative. This article highlights the dangers if you don't.

Common drug for diabetic foot pain isn’t effective, B.C. researchers say
Erin Ellis, Vancouver Sun 01.18.2016

A report by the Therapeutics Initiative at UBC suggests Lyrica only helps about one in 10 of the people to whom it is prescribed.JB REED / BLOOMBERG NEWS

A pain medication that rarely works as promised had a 17-fold increase in prescriptions over a decade, says the latest research from the Therapeutics Initiative at the University of B.C.

Its report says only about one in 10 patients will gain relief from pregabalin (trade name Lyrica), which is used to treat peripheral neuropathy — usually foot pain caused by diabetes — and other discomfort. Therapeutics Initiative is think-tank that reviews the usefulness of prescribed drugs and offers advice to B.C.’s doctors and pharmacists.

The latest work released Tuesday concludes that pregabalin, and two other painkillers studied, gabapentin and duloxetine (Cymbalta), all have little effect on pain despite extensive marketing campaigns promoting them.

Co-author Dr. Tom Perry, a clinical assistant professor in the department of anesthesiology, pharmacology and therapeutics at UBC, says doctors often tell patients to take these medications in higher doses and for a longer time than the evidence supports. Patients should know within days whether the medications are working for them, he says.

“These drugs are intended to make someone feel better; if you’re not feeling better, why take it?”

Perry and co-author Aaron Tejani, a clinical assistant professor in Pharmaceutical Sciences, looked information on gabapentin, pregabalin and a number of other medications gathered by Cochrane Reviews which evaluate scientific research from around the world. They found expectations of the drugs’ effectiveness far outstripped the evidence and likely drives an increasing number of prescriptions.

In B.C., pregabalin prescriptions rose 17 fold from 2005 through 2014, compared with a 1.8-fold increase in people receiving gabapentin.

Gabapentin is now available as a generic drug, but was formerly trademarked medication called Neurontin manufactured by Pfizer. The pharmaceutical giant agreed to pay $430 million in U.S. fines in 2004 after marketing it for unapproved uses such as migraine headaches and pain.

Combined costs of gabapentin, pregabalin, and duloxetine were over $52 million in British Columbia during 2014, says the Therapeutics Initiative report, of which Pharmacare paid over $13 million, mostly for gabapentin.

Pregabalin, also manufactured by Pfizer for neuropathic pain, is not covered under B.C.’s publicly funded Pharmacare following a recommendation by a national drug advisory committee in 2005. As a result, patients either pay for it out-of-pocket or through private health insurance,

Worse than simply buying a medication that’s not working, Perry says pregabalin is often prescribed to older adults who may become drowsy or lose their balance because of it.

Therapeutics Initiative is funded by the B.C. Ministry of Health through a grant to UBC.

eellis@vancouversun.com

http://www.vancouversun.com/health/common+drug+diabetic+foot+pain+effective+researchers/11662999/story.html

Lyrica Pregabalin Side Effects

Today's post from peoplespharmacy.com (see link below) adds to the ever-growing discussion about Lyrica (pregabalin) as a treatment for nerve pain. It may be worth stating here that in May 2012, the makers Pfizer, withdrew their positive advice for Lyrica, with regard to people with HIV-related or diabetes-related neuropathy. Many doctors across the world have chosen to ignore the hint and continue to prescribe the drug widely for both sorts of neuropathy patient. Like all other treatments for nerve pain it's a drug that can have significant side effects, so it's always worth discussing seriously with your doctor whether it's appropriate for you. Opinions seem to be divided but if Pfizer themselves will not promote their own best-seller for two types of neuropathy, it's certainly worth questioning if it's the right treatment for you. Other articles on Lyrica can be found by looking at the alphabetical list on the right of this blog.

Lyrica Side Effects and Withdrawal are Worrisome
August 1, 2013 in People's Pharmacy Alerts

Have you been seeing the ad blitz for Lyrica (pregabalin)? A LOT of money is being spent trying to convince the American public that Lyrica is the answer to diabetic nerve pain. One of the most compelling commercials stars a retired policeman:

"Hi, I'm terry and I have diabetic nerve pain. I worked a patrol unit for 17 years in the city of Baltimore. When I first started experiencing the pain it's hard to describe because you have a numbness but yet you have the pain like thousands of needles sticking in your foot."

Sounds awful and indeed people with diabetic neuropathy suffer terribly. Symptoms can include:

SYMPTOMS OF DIABETIC NEUROPATHY
Burning, tingling or a feeling of needles sticking into your skin
Numbness in toes and feet; an inability to sense a needle prick; reduced sensitivity to temperature change
Difficulty walking either because of numbness, pain or weakness
Intense stabbing jolts of pain, especially in the evening
Other complications of nerve damage include sexual dysfunction, swallowing difficulties, poor stomach emptying leading to feelings of fullness and bloating, bladder problems and dizziness on standing.

It's hardly any wonder that patients with neuropathy and nerve pain would be looking for help. A commercial like the one with Terry, the retired Baltimore police officer, is very appealing. When Terry says the "pain started subsiding" after taking Lyrica, we imagine that lots of viewers might think that they too might benefit from this drug. Are they paying attention, though, when the voice-over announcer says:

"Lyrica is not for everyone. It may cause serious allergic reactions or suicidal thoughts or actions. Tell your doctor right away if you have these: new or worsening depression or unusual changes in mood or behavior, or swelling, trouble breathing, rash, hives, blisters, changes in eye sight including blurry vision, muscle pain with fever, tired feeling or skin sores from diabetes. Common side effects are dizziness, sleepiness, weight gain, and swelling of hands, legs and feet. Don't drink alcohol while taking Lyrica. Don't drive or use machinery until you know how Lyrica affects you."

While you listen to the on-air announcer speed through this long list of complications you see Terry working in his backyard planting and watering pretty flowers. Somehow, the scary side effects seem less worrisome in such a bucolic setting.

Here are some real stories from our website to bring the side effects into focus:

This comes from LCB:

"I started taking Lyrica 10 days ago for RLS [restless leg syndrome] and fibromyalgia. I was taking gabapentin but it had stopped working. I gained 14 pounds on the gabapentin, and now I've gained 5 pounds more on the Lyrica. I have edema [fluid retention] as well. I'm sleepy for most of the day and I feel like I'm dragging my body around. I have no energy. My husband tells me I'm irritable with the kids, and that I can't seem to remember things anymore.

"All of this is quite a drastic change from my usual energetic, tireless self. I don't like how I feel, and to make the most important point: Lyrica doesn't seem to help much. I still have tons of pain, and RLS at night. So, I have an appointment with my doctor to ask for a change. I believe that these medicines work very well on some people, but we are all so different. It doesn't work for me."

T. had a very scary story to share:

"After almost eight years on Cymbalta, it had lost the effectiveness. My doctor added Lyrica to help with fibro. Soon after, I started to have a deep depression and wanted to end the pain that I have lived with for so long. The stress of life was so great, that I attempted suicide. I was put in the hospital for four days.

"At that point, no more meds! The symptoms are what everyone has described. I feel alone and lost in my own brain fog hell. Not one of my family has a clue what a nightmare this is."

Kathy listed these complicatons:

"I was on the drug eight months for fibromyalgia prescribed by a rheumatologist. I, too, started having problems with eyesight (my eye doctor could NOT update my lenses due to Lyrica causing severe blurriness). I also had memory loss, anxiety, and trouble sleeping. I suffer from chronic constipation due to diverticulitis, and the Lyrica was making this worse. I weaned off over a three-week period. OMG! The withdrawal was/is terrible.

"I am 9 weeks into it, and still have terrible throbbing ongoing headaches, difficulty swallowing, and went from 134 lbs to 118! I feel like I'm dying most of the time. I went to my current neurologist today and was told there were no such symptoms from Lyrica withdrawal!

"Google it, doctor! Please, if anyone reading this is considering taking Lyrica, reconsider! If you have side effects like I did, then decide to go off; you may be looking at a long recovery and NO help from a doctor. They are all denying any problems with this medication. Please read the "Lyrica Withdrawal" posts first!"

Getting off drugs that affect the central nervous system can sometimes be challenging. As we mentioned recently with our post on Abilify, the track record of psychiatry and neurology has been abysmal when it comes to studying sudden withdrawal from commonly prescribed medications. It took years for researchers to discover that when patients suddenly stopped benzodiazepines such as alprazolam (Xanax), diazepam (Valium) or lorazepam (Ativan) they often experienced very unpleasant withdrawal symptoms. Ditto for antidepressants like citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), sertraline (Zoloft) and venlafaxine (Effexor).

The story of Lyrica (pregabalin) withdrawal is also murky. There is very little in the medical literature on this topic. The prescribing information does mention, though, that some patients report symptoms such as insomnia, nausea, headache, anxiety, sweating or diarrhea if they stop suddenly. The advice: taper the dose over at least a week rather that stopping suddenly. We fear that such information is not always that helpful, especially since there is not much practical information about actual dosage reduction.


LYRICA SIDE EFFECTS:

Vertigo, dizziness, unsteadiness, coordination problems, abnormal gait
Sleepiness, fatigue
Confusion, abnormal thinking, difficulty with attention and concentration, accidental injury
Dry mouth
Fluid retention in hands or feet, edema
Blurred vision, difficulty with eyesight
Weight gain,
Constipation, gas
Pain
Skin reaction, rash, dermatitis (requires immediate medical attention!)
Depression, suicidal thoughts or actions
Muscle breakdown (rhabdomyolysis), tremor
Blood disorders
Withdrawal symptoms, discontinuation syndrome, seizures

We recognize that some people with hard-to-treat neuropathy or fibromyalgia may do quite well on Lyrica and not suffer side effects. That's great. But some patients don't get much benefit and do suffer complications. For them, Lyrica is not a blessing.

To learn about some other approaches to neuropathy, you may want to check these links about benfotiamine and alpha lipoic acid.

Please share your own story about Lyrica, neuropathy and what has worked or caused problems for you below in the comment section so others can benefit from your experience.

http://www.peoplespharmacy.com/2013/08/01/post-11/

Questionable Guidelines Promoting Lyrica For Neuropathy

Today's post from pulsetoday.co.uk (see link below) is an alarming example of how forces beyond the patient's understanding can promote and push for a particular drug to be prescribed when there are serious arguments for that to be a big mistake. Pfizer's patent on Lyrica (pregabalin) has recently expired, which means that if it's suitable for you, generic (and thus cheaper) pregabalin should be being prescribed as a matter of course and of course sound financial management. However, it seems that in the UK, the National Health Service is pressuring doctors to only prescribe the named version (Lyrica) and not the cheaper generic version. There are two huge problems for both diabetics and people with HIV-related neuropathy here. Two years ago and under pressure from the American FDA, Pfizer withdrew their own recommendation for Lyrica as a treatment for these forms of neuropathy a) because it was proved to be ineffective and b) because the side effects were causing all kinds of law suits. So you have to ask yourself why a national health authority such as the NHS is bringing so much pressure on doctors to prescribe the named drug for neuropathy as a whole and therefore including diabetes and HIV-related neuropathy. The advice here if you have diabetes or HIV and neuropathy, is to take heed of Pfizer's own negative advice and the FDA's warnings and have a serious discussion with your doctor if they wish to prescribe Lyrica for your problems. There is something evidently not right with what is described in this article and it may not be in your (the patient's) interest - you don't have to be subject to pharmaceutical market forces -  there are plenty of alternatives!
More articles on this subject can be found by using the search facility to the right of this blog.

GPs told to carry out review of patients taking pregablin 'as soon as possible'
6 March 2015 | By Caroline Price

CCGs will issue guidance to GPs instructing them to carry out an urgent review of patients taking pregabalin following a High Court ruling.

The guidance – which NHS England said CCGs must send out to all GP practices by today – advises practices they should review all patients on long-term prescriptions of pregabalin for neuropathic pain and make sure any on a generic version of the drug are switched to the branded form Lyrica.

In addition, NHS England said GPs should from now on make sure to stipulate Lyrica on any new prescriptions of pregabalin they write for patients being given the drug for pain.

GPs are free to continue prescribing generic versions of the drug for other conditions.

The move comes after a recent High Court ruling that the NHS should stop promoting generic pregabalin for neuropathic pain.

The guidance states: ‘When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible): prescribe by reference to the brand name Lyrica and write the prescription with only the brand name “Lyrica” and not the generic name pregabalin or any other generic brand.

‘When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin.’

And in a ‘frequently asked questions’ document accompanying the advice, NHS England explains that for new patients the guidance should be implemented ‘immediately’ and ‘when reasonably possible’ for repeat prescriptions.

But leading GPs criticised NHS England’s response, arguing it was not GPs’ role to take action and that practices were too overloaded to take on the work.

Dr Andrew Mimnagh, NHS Sefton CCG lead on urgent care, said it was up to dispensing pharmacists to resolve the issue.

Dr Mimnagh told Pulse: ‘Asking me to change a prescription for non-clinical reasons is not part of my professional duty of care or contractual obligation – I am not a contracted dispensor.

‘It is my belief NHS England are using GPs as the no-cost errand boy to sort their problem out, without regard for the intolerable workload pressures decimating the profession.’

An NHS England spokesperson told Pulse: ‘The NHS is committed to ensuring the best outcome for every patient. The primary objective for this unique case has been to ensure that practitioners are aware of new guidance when dispensing certain pain medication. Information will be provided to CCGs outlining this advice.’

The basic patent for Lyrica and regulatory data protection has expired. However, Pfizer has a second medical use patent (new therapeutic use) protecting the use of pregabalin in pain until July 2017.

Drugs company Pfizer holds the patent on pregabilin for use in neuropathic pain.

Pfizer said in a statement: ‘Pfizer is aware this is a relatively unusual exclusivity situation that has led to some confusion among prescribers and pharmacists. This is a legal matter not a clinical one. It is for this reason that we have been actively seeking to provide this essential guidance for prescribers and pharmacists by engaging with a broad range of stakeholders over the past six months, including the Department of Health, commissioning bodies, pharmacy associations as well as NHSE and other NHS devolved bodies.’

It continued: ‘In line with the measures sought by Pfizer to help prevent infringement of the pain patent, NHSE issued guidance on 27 February 2015 for prescribers via Clinical Commissioning Groups (CCGs) and pharmacists via NHS Business Services Authority (BSA) that directs the prescription and dispensing of Lyrica®, by brand name only, when pregabalin is used for the treatment of neuropathic pain. The NHSE guidance issued on Friday 27 February requests that the CCGs and NHS BSA distribute the notice on or before Friday 6 March 2015.’

The statement added: ‘The patent at issue, EP (UK) 0934061, expires in July 2017. A full hearing on the infringement and validity of the patent is scheduled to begin on 29 June 2015. Pfizer takes no issue with the supply of generic pregabalin products for use in the treatment of epilepsy or generalised anxiety disorder.’

http://www.pulsetoday.co.uk/clinical/prescribing/gps-told-to-carry-out-review-of-patients-taking-pregablin-as-soon-as-possible/20009393.article#.VPqtXC4tH7A

Capsaicin Patches Beat Lyrica Hands Down

Today's post from nationalpainreport.com confirms the obvious as far as this blog's concerned, as the disadvantages of Lyrica for certain neuropathy patient groups has been obvious for years (not least because of the fact that, under duress from the FDA, Pfizer themselves withdrew recommendation for it in relation to neuropathy and haven't changed their minds since). That capsaicin patches prove more effective is therefore no surprise here. That said, capsaicin patches have been on the market for years and although effective, need extreme care with application (preferably from a qualified medical practitioner) because of the possibility of painful burning side effects. However, with help, they can certainly reduce your nerve pain considerably and compared to the side effects of pregabalin (Lyrica), it's pretty much a no-brainer.

Capsaicin “Chili Pepper” Patch Beats Lyrica for Peripheral Neuropathic Pain
Posted on November 25, 2015 in Pain Medication 

A skin patch containing a synthetic version of capsaicin, the active ingredient in chili peppers, offers pain relief compared with Lyrica, but with faster pain relief, fewer side effects and greater treatment satisfaction, a new study concludes.

In a head-to-head study published in the European Journal of Pain, researchers compared capsaicin 8% patch (QUTENZA) with pregabalin capsules (Lyrica) in adults with peripheral neuropathic pain (PNP).

The study included 559 adults with moderate-to-severe PNP. Participants received either a single treatment with the capsaicin 8% patch or daily administration of an optimized dose of oral Lyrica.

Fifty-five percent (55%) of those using the capsaicin 8% patch achieved 30% or greater pain relief, compared to 54% of those using pregabalin, showing “non-inferior” pain relief.

But, what differed was how the patch offered faster pain relief. Those taking the patch achieved pain relief in 7.5 days compared to 36 days with pregabalin.

“This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day,” said Professor Maija Haanpää, Principal Study Investigator, Department of Neurosurgery, Helsinki University Central Hospital, Helsinki.

“Some patients may still receive inadequate pain management and have to balance effective pain relief and the side effects of their medication. The capsaicin 8% patch is applied topically and hence has shown less systemic side effects than seen with oral medications. There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain,” commented Dr. Andreas Karas, Senior Director, Medical Affairs, Astellas Pharma EMEA.

Peripheral neuropathic pain is a problem with the functioning of the nerves outside the spinal cord. Symptoms of peripheral neuropathy may include numbness, weakness, burning pain (especially at night), and loss of reflexes.

Lyrica is approved by the FDA to treat chronic pain associated with fibromyalgia, epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury.

The Qutenza (capsaicin) 8% patch is FDA approved to treat long-term pain associated with shingles attacks.

http://nationalpainreport.com/capsaicin-chili-pepper-patch-beats-lyrica-for-peripheral-neuropathic-pain-8828365.html

Pregabalin Lyrica Once Again Ineffective

Today's post from sciencedaily.com (see link below) takes another look at pregabalin (lyrica) and although this article reveals its shortcomings when treating lower back pain, people with neuropathy who take lyrica should not be disheartened or suprised if it doesn't work for you. Apart from the fact that Pfizer themselves have withdrawn recommendations for taking lyrica for both diabetic and HIV-related neuropathy (which should be warning enough), many doctors still prescribe it for all nerve damage related symptoms. There is growing evidence to show that it is frequently ineffective and that's not to mention the potential side effects, which have led people to take Pfizer to court and have resulted in the company withdrawing its own positive support for certain conditions. Gabapentin (also not without its critics) or cymbalta may be a better option in most cases where it has failed but people living with diabetic and HIV-related neuropathy should really have a serious talk with their doctors before even beginning with Lyrica (pregabalin) - it's possibly not the wisest option!
 

Commonly prescribed painkiller not effective in controlling lower back pain
Source: University of Rochester Medical Center  Date: December 10, 2014

Summary:

Pregabalin is not effective in controlling the pain associated with lumbar spinal stenosis, the most common type of chronic lower back pain in older adults, a study concludes. Pregabalin, which is marketed by Pfizer under the name Lyrica, is approved to treat chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. However, it is also commonly prescribed as an "off label" treatment for chronic low back pain syndromes like lumbar spinal stenosis.

A new study out in the journal Neurology shows that pregabalin is not effective in controlling the pain associated with lumbar spinal stenosis, the most common type of chronic lower back pain in older adults.

"Chronic low back pain is one of the most common reasons why older adults go to the doctor and lumbar stenosis is the leading indication for surgery in this age group," said John Markman, M.D., director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery and lead author of the study. "While physicians have increasingly looked for medication alternatives to opioid pain medication like gabapentin and pregabalin to help these patients manage their pain, until now there has been no credible evidence as to whether or not these treatments are effective for this problem."

Pregabalin, which is marketed by Pfizer under the name Lyrica, is approved to treat chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. However, it is also commonly prescribed as an "off label" treatment for chronic low back pain syndromes like lumbar spinal stenosis.

Lumbar spinal stenosis is brought about by a narrowing of the spinal canal caused by the degeneration of the vertebrae, discs, muscles, and ligaments that comprise the spinal column. This results in a compression of nerve roots that can trigger pain, tingling, and numbness in the lower back, buttocks, and legs. The pain is most commonly experienced when a person is upright or walking and can be lessened by bending forward at the waist, which is often why one sees older adults hunched over with a cane or a walker.

While some narrowing of the spinal canal occurs with normal aging and does not always cause pain, more severe compression of nerves limits mobility and leads patients to try stronger pain medications and epidural steroid injections in an attempt to control the pain that is associated with walking and standing.

Patients also often decide to undergo surgery that removes a portion of the bone or disc to give the nerve roots more room. The procedure -- called a lumbar laminectomy -- is the most common reason for spine surgery in people over the age of 60. While the surgery is initially highly successful, the pain often returns after a number of years. Also, for some patients, surgery is not an option.

For a long time, physicians have attempted to expand the arsenal of medications available to treat this condition. In fact, it is estimated that more than two thirds of the pain treatment regimens currently being used for lumbar spinal stenosis consist of drugs like pregabalin that are not approved by the Food and Drug Administration for the condition.

The new study employed a novel approach to evaluating the effectiveness of pain treatments. Because the pain associated with the lumbar spinal stenosis is present when a person is upright or walking, the researchers asked individuals with the condition to report their pain levels while walking on a treadmill. They found there was no significant difference in the levels of pain experienced by those taking the drug and those that received a placebo.

"Given the cost and potential side effects associated with pregabalin, it is critical that we understand the efficacy of this drug," Markman said. "This study convincingly demonstrates a lack of relief with pregabalin for the walking pain associated with lumbar spinal stenosis."

Story Source:

The above story is based on materials provided by University of Rochester Medical Center. Note: Materials may be edited for content and length.

Journal Reference:
J. D. Markman, M. E. Frazer, S. A. Rast, M. P. McDermott, J. S. Gewandter, A. K. Chowdhry, K. Czerniecka, W. H. Pilcher, L. S. Simon, R. H. Dworkin. Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication. Neurology, 2014; DOI: 10.1212/WNL.0000000000001168
 
http://www.sciencedaily.com/releases/2014/12/141210162318.htm

Pregabalin Lyrica

(...Treatments 1)

This is an example of a drug working better for diabetic patients, than for HIV patients, with neuropathy. Like everything else, the study is not definitive but it may be worthwhile discussing these findings with your neurologist or HIV specialist. Because it seems to perform much better against the placebo in the short term, that may be the reason why many HIV patients see the benefits of Lyrica but the findings suggest that the success falls away over a longer period of time.

IAC: Pregabalin Fails to Control HIV Neuropathic Pain Better than Placebo
By Ed Susman, Contributing Writer, MedPage Today
Published: August 08, 2008
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

MEXICO CITY, Aug. 8 -- The anti-convulsant pregabalin (Lyrica) did better than placebo in controlling HIV-related neuropathic pain in the short term, but not over the long haul, researchers found.

Treatment with pregabalin produced a significant reduction in neuropathic pain at two weeks, reducing the NRS-Pain score by two points compared with a 1.5-point decrease in scores among placebo patients (P<0.05), David Simpson, M.D., of Mount Sinai School of Medicine in New York, reported at the International AIDS Conference. However, he said, at the end of the 12-week period the pain reduction among pregabalin patients was about 3.2 points compared with 2.5 points among placebo patients -- a difference that did not reach statistical significance. "The effect of pregabalin on neuropathic pain in this study was similar to the effect observed in diabetic neuropathy and in post-herpetic neuropathy studies, but in this study there was a far larger placebo effect than the other studies." That negated the difference, Dr. Simpson said. "Placebo effects in these neuropathy studies always cause problems as far as having a successful trial is concerned," said John Mellors, M.D., of the University of Pittsburgh. He said that patient expectation and increases in endorphin levels can interfere with outcomes, especially in trials in which subjective measures of pain are the endpoints. In the pregabalin trial, patients with moderate to severe neuropathic pain secondary to HIV infection or treatment -- 6.7 on a scale of 1 to 10 -- were randomized into two arms, each with 151 individuals. About 80% of the patients were men, with an average age of 48; about 58% were white and about 31% were black. The mean years with an HIV diagnosis was about 13, and patients had complained of neuropathy symptoms for about six years. Although pregabalin was unable to show a difference from placebo in this neuropathy patient population, the drug has also received approval for treatment of pain in diabetic neuropathy patients. The study was sponsored by Pfizer, Inc.
Dr. Simpson has disclosed relationships with Cephalon, NeurogesX, Pfizer and Eli Lilly.
Dr. Mellors has disclosed relationships with Abbott Laboratories, Achillion Pharmaceuticals, Bristol-Myers Squibb, Agouron Pharmaceuticals, Boehringer-Ingelheim, Gilead Sciences, GlaxoSmithKline, Intelligent Therapeutic Solutions, Merck, Noviro/Idenix, Pfizer, Pharmasset, Triangle Pharmaceuticals, Trimeris, Virco-Tibotec and Visible Genetics.

http://www.medpagetoday.com/MeetingCoverage/IAC/10489

How Much Longer Will Lyrica Be A First Choice Neuropathy Drug

Today's post from sciencedaily.com (see link below) needs to be taken seriously, if only because it comes from sciencedaily.com, which is one of the most trusted medical sites on the internet. You may wonder what an article about birth defects has to do with neuropathy but the common link is the drug pregabalin (Lyrica). Despite Pfizer withdrawing its own recommendation for Lyrica for many forms of neuropathy as long ago as 2013 and despite the mounting evidence of the harm it can do, it remains one of the most widely prescribed mainstream drugs for nerve pain across the whole world. The reasons for this are unclear but you have to suspect the mass marketing of the drug still goes on and of course doctors still make use of so-called 'off-label prescribing because the right information is not getting through. This particular article looks at the evidence of the potential for birth defects due to pregabalin but this is just the latest in a long line of contra-indications for Lyrica. If it is prescribed for your neuropathy symptoms, you should probably have a serious discussion with your doctor and maybe take along some of the evidence you can find here on the blog (type 'pregabalin' in the search box to the right of the page) because there's a distinct possibility that it may do you more harm than good.

Drug used for pain, anxiety may be linked to birth defects 
Date: May 18, 2016 Source: American Academy of Neurology (AAN)

A drug commonly used to treat pain, epilepsy, anxiety and other brain health disorders may be associated with an increased risk of major birth defects, according to a study published in the May 18, 2016, online issue of Neurology®, the medical journal of the American Academy of Neurology.

The drug pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy or pain after shingles or spinal cord injury. It is also used for generalized anxiety disorder and other mental health issues. This is called off-label prescribing.

For the study, information was collected in seven countries from 164 women who took pregabalin during a pregnancy and 656 pregnant women who were not taking any anti-seizure drugs. The women or their practitioners were then contacted again after their expected date of delivery.

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of the women who did not take anti-seizure drugs. Seven of the 116 pregnancies in women taking anti-seizure drugs, or 6 percent, had major birth defects, compared to 12 of 580 pregnancies, or 2 percent, in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the central nervous system than women who were not taking the drug, with four CNS defects out of 125 pregnancies, or 3.2 percent, compared to three CNS defects out of 570 pregnancies, or 0.5 percent.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis, five were taking it for epilepsy and one was taking it for restless leg syndrome.

A total of 77 percent of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22, or 13 percent, were also taking another anti-seizure drug.

"We can't draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy," said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.

Winterfeld said, "Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted."

Story Source:

The above post is reprinted from materials provided by American Academy of Neurology (AAN). Note: Materials may be edited for content and length.

Journal Reference:
Ursula Winterfeld, Paul Merlob, David Baud, Valentin Rousson, Alice Panchaud, Laura E. Rothuizen, Nathalie Bernard, Thierry Vial, Laura M. Yates, Alessandra Pistelli, Maria Ellfolk, Georgios Eleftheriou, Loes C. de Vries, Annie-Pierre Jonville-Bera, Mine Kadioglu, Jerome Biollaz, and Thierry Buclin. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology, May 2016 DOI: 10.1212/WNL.0000000000002767

https://www.sciencedaily.com/releases/2016/05/160518170014.htm