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Fda Approved Drugs For Diabetic Neuropathy

Treating Painful Diabetic Peripheral Neuropathy: An Update

Treating Painful Diabetic Peripheral Neuropathy: An Update

Painful diabetic peripheral neuropathy occurs in approximately 25% of patients with diabetes mellitus who are treated in the office setting and significantly affects quality of life. It typically causes burning pain, paresthesias, and numbness in a stocking-glove pattern that progresses proximally from the feet and hands. Clinicians should carefully consider the patient's goals and functional status and potential adverse effects of medication when choosing a treatment for painful diabetic peripheral neuropathy. Pregabalin and duloxetine are the only medications approved by the U.S. Food and Drug Administration for treating this disorder. Based on current practice guidelines, these medications, with gabapentin and amitriptyline, should be considered for the initial treatment. Second-line therapy includes opioid-like medications (tramadol and tapentadol), venlafaxine, desvenlafaxine, and topical agents (lidocaine patches and capsaicin cream). Isosorbide dinitrate spray and transcutaneous electrical nerve stimulation may provide relief in some patients and can be considered at any point during therapy. Opioids and selective serotonin reuptake inhibitors are optional third-line medications. Acupuncture, traditional Chinese medicine, alpha lipoic acid, acetyl-l-carnitine, primrose oil, and electromagnetic field application lack high-quality evidence to support their use. Painful diabetic peripheral neuropathy (DPN) occurs in approximately 30% of patients with diabetes mellitus who are hospitalized and in 25% of patients with diabetes who are treated in the office setting.1 It develops as a late manifestation of uncontrolled or long-standing diabetes.1 As many as 12% of patients with painful DPN do not report symptoms, and 39% of patients with the disorder do not receive any Continue reading >>

Fda Approves Tapentadol Er For Diabetic Neuropathy

Fda Approves Tapentadol Er For Diabetic Neuropathy

FDA Approves Tapentadol ER for Diabetic Neuropathy August 29, 2012 The US Food and Drug Administration (FDA) has approved tapentadol extended-release (ER) (Nucynta, Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time. It is the first opioid to receive this indication, the company notes in a statement today. DPN, the most common type of neuropathy, affects an estimated 16% of the more than 25 million Americans who have diabetes. The condition is often unreported and untreated, with an estimated 2 out of 5 cases not receiving care. Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states. "Although the clinical relevance is unclear," the company notes, preclinical studies showed that it acts as both a mu-opioid receptor and a norepinephrine reuptake inhibitor. The supplemental New Drug Application for this indication was based on data from 2 randomly assigned withdrawal, placebo-controlled phase 3 trials showing that among patients who had at least a 1-point reduction in pain intensity during 3 weeks of treatment with tapentadol ER, those who continued on the same dose titrated to balance individual tolerability and efficacy (100 to 250 mg twice daily) for an additional 12 weeks experienced significantly better pain control compared with those who switched to placebo. The research also demonstrated that tapentadol ER was generally well tolerated. The most common adverse reactions, affecting 10% or more of Continue reading >>

Lyrica New Fda Drug Approval | Centerwatch

Lyrica New Fda Drug Approval | Centerwatch

Lyrica (pregabalin) is a modulator of voltage-gated calciumchannels, designed to affect neurological transmission in multiplesystems. Lyrica is specifically indicated for the treatment ofneuropathic pain associated with diabetic peripheral neuropathy,and postherpetic neuralgia. It is also indicated as an adjunctivetherapy for the treatment of adult patients with partial onsetseizures. Lyrica is supplied as a hard-gelatin capsule for oraladministration. Recommended initial dosing for the treatment ofneuropathic pain associated with diabetic peripheral neuropathy is50 mg thrice daily, with escalation permissible to 100 mg thricedaily within 1 week in patients with creatinine clearance of atleast 60 ml/min, based on tolerability and efficacy. For thetreatment of postherpetic neuralgia, recommended initial dosing is75 mg twice daily or 50 mg thrice daily (in patients withcreatinine clearance >60 ml/min), with escalation to 150 mgtwice daily or 100 mg thrice daily (in patients with creatinineclearance >60 ml/min) permissible. For the adjunctive treatmentof epilepsy, recommended initial dosing is 150 mg daily (as 50 mgthrice daily or 75 mg twice daily), with escalation to a maximumtotal daily dose of 600 mg (200 mg thrice daily or 300 mg twicedaily) based on efficacy and tolerability. On conclusion of Lyricatherapy, dosing should be tapered over at least 1 week. Neuropathic Pain associated with Diabetic PeripheralNeuropathy Approval of Lyrica for the treatment of neuropathic pain associatedwith diabetic peripheral neuropathy was based on results of 3double-blind, placebo-controlled multicenter trials. Two of thesestudies investigated the maximum recommended dose of the drug: Study DPN 1: This study enrolled 337 patients, whowere randomized to receive one of 3 doses of the dr Continue reading >>

Antidepressants, Seizure Meds Ok For Diabetic Neuropathy Pain

Antidepressants, Seizure Meds Ok For Diabetic Neuropathy Pain

For the treatment of diabetic peripheral neuropathy pain (DPN), certain antidepressants and anticonvulsants ranked best, according to a systematic review. Published in the journal Neurology, the medical journal of the American Academy of Neurology (AAN), the findings by lead author Julie M. Waldfogel, PharmD, of Johns Hopkins Hospital in Baltimore, and colleagues showed that the serotonin-norepinephrine reuptake inhibitors (SNRIs) duloxetine and venlafaxine were more effective at reducing DPN pain compared with placebo, based on moderately strong evidence. Lower-grade evidence found that pregabalin and oxcarbazepine were also more effective at reducing pain due to DPN versus placebo. Similar findings were reported for tricyclic antidepressants, atypical opioids, and botulinum toxin. "Our results generally support the effectiveness of the three drugs approved by the FDA for the treatment of DPN pain: duloxetine, pregabalin, and tapentadol, which is not surprising," Waldfogel told MedPage Today via email. "Our results also continue to suggest that other medications such as oxcarbazepine, TCAs [tricyclic antidepressants], venlafaxine, and tramadol may be effective." The findings add to the latest treatment guidelines, published in 2011 by the American Association of Neuromuscular and Electrodiagnostic Medicine, the AAN, and the American Academy of Physical Medicine & Rehabilitation, which recommended pregabalin as an established effective treatment method based on the strongest evidence of research. The current guideline also notes that venlafaxine, duloxetine, amitriptyline, gabapentin, valproate, capsaicin, and opioids including morphine sulfate, tramadol, and oxycodone controlled-release are also potentially effective treatment methods, based on lower-grade evidence. "T Continue reading >>

Patient Education: Diabetic Neuropathy (beyond The Basics)

Patient Education: Diabetic Neuropathy (beyond The Basics)

DIABETIC NEUROPATHY OVERVIEW Neuropathy is the medical term for nerve damage. Neuropathy is a common complication of type 1 and type 2 diabetes; up to 26 percent of people with type 2 diabetes have evidence of nerve damage at the time that diabetes is diagnosed [1]. A generalized type of neuropathy, known as polyneuropathy, is the most common type of diabetic neuropathy. Other types of neuropathy can also affect people with diabetes, but will not be discussed here. Signs and symptoms of diabetic neuropathy include loss of sensation and/or burning pain in the feet. Early detection of diabetes and tight control of blood sugar levels may reduce the risk of developing diabetic neuropathy. Treatments for diabetic neuropathy are available, and include several elements: control of blood glucose levels, prevention of injury, and control of painful symptoms. DIABETIC NEUROPATHY RISK FACTORS In people with type 1 or type 2 diabetes, the biggest risk factor for developing diabetic neuropathy is having high blood sugar levels over time. Other factors can further increase the risk of developing diabetic neuropathy, including: Coronary artery disease Increased triglyceride levels Smoking High blood pressure DIABETIC NEUROPATHY SYMPTOMS The most common symptoms of diabetic neuropathy include pain, burning, tingling, or numbness in the toes or feet, and extreme sensitivity to light touch. The pain may be worst at rest and improve with activity, such as walking. Some people initially have intensely painful feet while others have few or no symptoms. Diabetic neuropathy usually affects both sides of the body. Symptoms are usually noticed first in the toes. If the disease progresses, symptoms may gradually move up the legs; if the mid-calves are affected, symptoms may develop in the hands. Continue reading >>

Medications For Diabetic Peripheral Neuropathy

Medications For Diabetic Peripheral Neuropathy

Other names: Diabetic Nerve Damage; DPN Drug name Rx / OTC Pregnancy CSA Alcohol Reviews Rating Popularity gabapentin Off Label Rx C N X 38 reviews 6.0 Generic name: gabapentin systemic Drug class: gamma-aminobutyric acid analogs For consumers: dosage, interactions, side effects For professionals: A-Z Drug Facts, AHFS DI Monograph, Prescribing Information Off Label: Yes Lyrica Rx C 5 X 49 reviews 6.0 Generic name: pregabalin systemic Drug class: gamma-aminobutyric acid analogs For consumers: dosage, interactions, side effects For professionals: AHFS DI Monograph, Prescribing Information Cymbalta Rx C N X 33 reviews 6.0 Generic name: duloxetine systemic Drug class: serotonin-norepinephrine reuptake inhibitors For consumers: dosage, interactions, side effects For professionals: AHFS DI Monograph, Prescribing Information Topamax Off Label Rx D N X 4 reviews 9.0 Generic name: topiramate systemic Drug class: carbonic anhydrase inhibitor anticonvulsants For consumers: dosage, interactions, side effects For professionals: AHFS DI Monograph, Prescribing Information Off Label: Yes Nucynta ER Rx C 2 X 8 reviews 8.0 Generic name: tapentadol systemic Drug class: narcotic analgesics For consumers: dosage, interactions, side effects For professionals: Prescribing Information pregabalin Rx C 5 X 51 reviews 6.0 Generic name: pregabalin systemic Brand name: Lyrica Drug class: gamma-aminobutyric acid analogs For consumers: dosage, interactions, side effects For professionals: A-Z Drug Facts, AHFS DI Monograph duloxetine Rx C N X 36 reviews 6.0 Generic name: duloxetine systemic Brand names: Cymbalta, Irenka Drug class: serotonin-norepinephrine reuptake inhibitors For consumers: dosage, interactions, side effects For professionals: A-Z Drug Facts, AHFS DI Monograph, Prescribing Information Continue reading >>

Treating Diabetic Peripheral Neuropathic Pain

Treating Diabetic Peripheral Neuropathic Pain

Diabetic peripheral neuropathic pain affects the functionality, mood, and sleep patterns of approximately 10 to 20 percent of patients with diabetes mellitus. Treatment goals include restoring function and improving pain control. Patients can realistically expect a 30 to 50 percent reduction in discomfort with improved functionality. The main classes of agents used to treat diabetic peripheral neuropathic pain include tricyclic antidepressants, anticonvulsants, serotonin-norepinephrine reuptake inhibitors, opiates and opiate-like substances, and topical medications. Physicians should ask patients whether they have tried complementary and alternative medicine therapies for their pain. Only two medications are approved specifically for the treatment of diabetic peripheral neuropathic pain: pregabalin and duloxetine. However, evidence supports the use of other therapies, and unless there are contraindications, tricyclic antidepressants are the first-line treatment. Because patients often have multiple comorbidities, physicians must consider potential adverse effects and possible drug interactions before prescribing a medication. Peripheral neuropathy is a common complication of diabetes mellitus, occurring in 30 to 50 percent of patients with the disease.1 It involves the loss of sensation in a symmetric stocking-and-glove distribution, starting in the toes and progressing proximally. Approximately 10 to 20 percent of patients with diabetes have diabetic peripheral neuropathic pain, which is a burning, tingling, or aching discomfort that worsens at night.1,2 Patients with diabetic peripheral neuropathic pain may also experience allodynia and hyperalgesia. Diabetic peripheral neuropathic pain interferes with sleep quality, mood, and activity level. Initial management goals Continue reading >>

What Is Diabetic Neuropathy?

What Is Diabetic Neuropathy?

Manufacturer Pfizer has issued a voluntary recall of two strengths of Lyrica (pregabalin). Lyrica is a popular medication used to help relieve nerve pain, and in combination with other medications for some kinds of seizures. This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. August 21, 2014 It’s now one of the 10 most prescribed drugs in the United States. Lyrica (pregabalin) is a medication that is chemically and structurally similar to Neurontin (gabapentin) and is used for a wide variety of things: seizure disorder, pain and anxiety. So what is this Lyrica you hear so much about? Pain. Real tooth-achy nerve pain. Lyrica is approved for the treatment of neuropathic pain. Nerve pain is burning, sharp, stabbing and numbing pain. December 12, 2013 Depression, anxiety, chronic pain, fibromyalgia, neuropathy and hot flashes are some of the many issues Cymbalta helps you tackle. The cost, however, has been a real issue for patients. Now, you’re good. The Food and Drug Administration (FDA) has approved the first generic versions of Cymbalta, duloxetine delayed-release capsules. Several different drug companies had their generic versions accepted so there will be many folks making duloxetine; this should lower the cost quite a bit. Continue reading >>

Treatment Of Neuropathic Pain

Treatment Of Neuropathic Pain

Jeffrey Fudin, PharmD, DAAPM, FASHP, FCCP; Jeffrey Bettinger, PharmD Candidate; and Erica Wegrzyn, BA, BS, PharmD Chronic pain has been defined by the International Association for the Study of Pain (IASP) as pain that persists beyond the normal tissue healing time of 3 months, and it may be classified into 3 distinct categories: nociceptive, neuropathic, and a mixture of the two.1,2 Neuropathic pain is somatosensory system disease or damage, which can be caused by a wide variety of nerve-damaging diseases or medications affecting the peripheral or central nervous system.2 There are many FDA-approved and off-label therapies for the treatment of neuropathic pain that provide effectiveness through a variety of mechanisms and differ vastly in their pharmacokinetic and pharmacodynamic profiles. Definitions and Pathophysiology of Neuropathic Pain Neuropathic pain has been described as pain initiated or caused by a primary lesion, dysfunction, or transitory perturbation in the peripheral or central nervous system.1 Several mechanisms have been identified in the pathogenesis of neuropathic pain, but it is a lesion to afferent pathways that must be present for the syndrome to even develop.2 These lesions may lead to spontaneous ectopic nerve impulse generation within damaged and neighboring nociceptive fibers (C-fibers and Alpha-delta-fibers); upregulation of voltage-gated sodium channels, which contributes to changes in membrane excitability; central sensitization development as a consequence of ectopic activity; or constant release of excitatory amino acids and neuropeptides throughout the peripheral afferent fibers that leads to excitation of several receptors, such as N-methyl-D-aspartate (NMDA) and alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic.2-6 These varying mech Continue reading >>

Medications To Treat Diabetic Peripheral Neuropathy

Medications To Treat Diabetic Peripheral Neuropathy

Medications are used to control the pain associated with peripheral diabetic neuropathy. Unfortunately, at this time, there aren’t any medications to treat and prevent diabetic nerve pain (another name for diabetic neuropathy); the only way to do that is through careful control of blood glucose levels. There are many medication options to relieve pain associated with peripheral nerve damage. You should work carefully with your doctor to figure out what medications are best for you. If you’d like to learn more about treatments for the other types of diabetic neuropathy, this section of the article reviews treatment options for autonomic, proximal, and focal neuropathy. Medication Warning Because of the possible interactions and side effects, always discuss medications with your doctor—even if they’re “just” over-the-counter. This is particularly important when you have diabetes because these over-the-counter medications may have interactions with other medications you’re using. Over-the-counter Medications for Diabetic Peripheral Neuropathy For people in the early stages of diabetic neuropathy—when the pain isn’t severe—over-the-counter medications may be enough to relieve the pain. However, people with more advanced nerve damage may not find over-the-counter medications helpful. For diabetic neuropathy, you may want to try: Acetaminophen: This is a painkiller, also known as an analgesic. Tylenol is an example of acetaminophen, and it works by blocking pain messages to the brain. In essence, acetaminophen makes it harder for the “pain” signal to travel through the nerves and to the brain, and therefore, the brain doesn’t know that it should be feeling pain. Possible side effects include liver damage, but that’s after taking large quantities fo Continue reading >>

Fda Approves New Neuropathy Pain Drug

Fda Approves New Neuropathy Pain Drug

The US Food and Drug Administration has approved US sales of NUCYNTA ER (tapentadol), a twice-daily extended-release oral analgesic for the treatment of pain from diabetic peripheral neuropathy. The drug, produced by New Jersey-based Janssen Pharmaceuticals, Inc., provides around-the-clock management for moderate to severe chronic neuropathic pain. Janssen says that it is currently the only opioid on the US market that has been approved for treating the condition. An estimated 8 million people in the United States suffer from diabetic peripheral neuropathy, a condition in which high blood sugar inflames and damages nerves in the extremitiesarms, hands, legs, feet, and toes. The most common symptoms are numbness, burning, tingling, or tickling sensations in the affected areas. However, those symptoms often give way to extreme pain. Treatment for diabetic neuropathy pain can involve the use of several drug agents, including anti-seizure medications, antidepressants, lidocaine topical patches, and opioids used to treat pain in general. All drugs used to treat the condition have side effects, the most common being dizziness and drowsiness. Janssen states that most common adverse reactions reported by patients treated with NUCYNTA ER were nausea, constipation, vomiting, dizziness, headache, and sleepiness. Because the active ingredient in NUCYNTA ER, tapentadol, is classified as a controlled substance, it will be available by prescription only. The twice-daily pill will come in strengths of 50, 100, 150, 200, and 250 mg. Janssen has listed certain cautions about the drug, including the potential for abuse because of the drugs opioid nature, the possibility of life-threatening respiratory depression if the drug is ingested improperly (such as crushing the pill so that its ex Continue reading >>

Peripheral Neuropathy Could Be Reversed By Fda-approved Class Of Drugs

Peripheral Neuropathy Could Be Reversed By Fda-approved Class Of Drugs

Treatments for peripheral neuropathy, the numbness and pain most commonly felt in the fingers, arms and legs due to nerve damage, tend to focus on managing pain. But an international team may have found an alternative approach that could potentially reverse symptoms with a class of drugs already in use for other conditions. Addressing the underlying condition behind neuropathy—such as diabetes—is a major part of alleviating symptoms, but there is no approved treatment that focuses on nerve degeneration. While studying mechanisms involved in neuron growth and regrowth, scientists from UC San Diego and the University of Manitoba, alongside colleagues from St. Boniface Hospital and the National Institute of Diabetes and Digestive and Kidney Diseases, identified a pathway that stunts the outgrowth of neurites, which connect neurons to other neurons. The activation of muscarinic acetylcholine receptors inhibits the growth of sensory neurons. The team found that blocking this pathway reversed the effects of peripheral neuropathy in mouse models of Type 1 and 2 diabetes, HIV and chemotherapy-induced neuropathy. Their findings were published in the Journal of Clinical Investigation. The best part? A number of antimuscarinic drugs, such as atropine and pirenzepine, are already approved and on the market for other indications, ranging from incontinence to peptic ulcers. This could lead to a potentially speedy path to clinical use. Paul Fernyhough of the University of Manitoba and St. Boniface Hospital, Nigel Calcutt of UC San Diego and Lakshmi Kotra of the University of Toronto have cofounded the company WinSanTor to continue working on this approach. The biotech has exclusively licensed the technology from the researchers and has come up with a repurposed and reformulated ve Continue reading >>

Diabetic Neuropathy

Diabetic Neuropathy

Are You Sure the Patient Has Diabetic Neuropathy? History: It is important to unveil the presence of risk factors (e.g., poorly controlled hyperglycemia; tall stature; associated dyslipidemia with elevated triglycerides; hypertension; and history of recent falls, which may reflect gait and balance disorders). Symptoms: May vary due to the type of sensory fibers involved Pain - most common symptoms that would prompt seeking medical care; intensity may vary from dull to lancinating and disabling; often is worse at night and disrupts sleep Dysesthesia - unpleasant sensations of burning, tingling, excessive sensitivity to touch; in same areas as peripheral nerve lesions Numbness - feeling as feet of hands are asleep Weakness - less common, usually minor; occurs later in the disease process Anatomic distribution of symptoms and signs is a very important clue: The most distal portion of the longest nerves is affected first. Early symptoms typically involve the tips of the toes and fingers. This proceeds proximally, resulting in a "stocking-glove" pattern of pain and sensory loss. Symptoms of autonomic neuropathy occur, in general, late in the course of the disease and varies based on the form of autonomic neuropathy. Symptoms associated with orthostatic hypotension: Sensory loss is defined in terms of extent and distribution, and involves assessment of: A potentially quick, inexpensive, and accurate screening instrument to evaluate high-risk patients in the clinic is the Michigan neuropathy screening instrument (MNSI) and includes assessment for: Loss of vibration sense (using a 128-Hz tuning fork) is tested at the big toe. (Image) Vibration sensation should be assessed with the big toe unsupported. Vibration sensation should be tested bilaterally by placing the tuning fork Continue reading >>

Pharmacological Treatment Of Diabetic Peripheral Neuropathy

Pharmacological Treatment Of Diabetic Peripheral Neuropathy

Pharmacological Treatment Of Diabetic Peripheral Neuropathy Kenneth Cohen , PharmD, PhD, CGP, Nataliya Shinkazh , PharmD, BCPS, CDE, Jerry Frank , MD, FAAFP, Igor Israel , MD, and Chris Fellner Dr. Cohen is an Associate Professor of Pharmacy Practice at Touro College of Pharmacy in New York, New York. Dr. Shinkazh is an Assistant Professor of Pharmacy Practice at Touro College. Dr. Frank is a Clinical Assistant Professor in the Department of Family Medicine at SUNY Stony Brook School of Medicine in Stony Brook, New York. Dr. Israel is Associate Medical Director at the Parker Jewish Institute in New Hyde Park, New York. Chris Fellner is Editor of PTCommunity.com at MediMedia Managed Markets in Yardley, Pennsylvania. Disclosure: The authors report no commercial or financial interests in regard to this article. Diabetic peripheral neuropathy (DPN) has been recognized as a major complication of diabetes since the mid-1800s. 1 Dyck et al. described the disorder as a symmetrical sensorimotor polyneuropathy attributable to chronic hyperglycemia, associated metabolic derangements, cardiovascular risk covariates, and microvessel alterations. Abnormal nerve conduction appears to be the first objective indication of DPN. 2 Both vascular and metabolic factors are involved in the development of DPN. 3 , 4 Patients with the disorder typically experience the loss of nerve fibers due to impaired blood flow, resulting in impaired nerve sensitivity or pain. 5 7 Patients with DPN also develop vascular deformities and hypertrophy as well as reduced oxygen tension compared with normal individuals. 5 These effects underscore the relationship between vascular and neurostructural changes in patients with DPN. 8 Further, elevated intracellular glucose levels in both vascular and neural tissues Continue reading >>

Diabetic Neuropathy Treatments

Diabetic Neuropathy Treatments

Diabetic peripheral neuropathy is the most common and most painful type of diabetic neuropathy, which is nerve damage caused by diabetes. To find pain relief from diabetic peripheral neuropathy, you have several medication options. Before starting any medication—even over-the-counter medications—you should discuss the medication with your doctor. It may have side effects you’re unaware of, or it may have interactions with other medications you’re taking. Especially since you have diabetes, you should talk to your doctor about medication options. Medications for diabetic peripheral neuropathy cannot, unfortunately, prevent more nerve damage. To do that, you should work hard to keep your blood glucose levels near normal. Frequent blood glucose monitoring, as well as careful meal planning, exercise, and diabetes medications or insulin, can help you control your blood glucose levels. Over-the-counter Medications for Diabetic Peripheral Neuropathy If your diabetic peripheral neuropathy is in the early stages, over-the-counter medications may provide pain relief. But remember, check with your doctor before taking these. For nerve pain relief, you can try: topical medications: People who have foot pain from diabetic peripheral neuropathy sometimes use topical medications, which you apply directly to your skin. Capsaicin cream, for example, can temporarily reduce pain. Prescription Medications for Diabetic Peripheral Neuropathy There are several prescription medications that can be used to treat more severe diabetic peripheral nerve pain. Your doctor will explain your medication options to you and help you find the best option for you. It may be necessary to take more than one medication to deal with the effects of nerve pain. Three prescription medications are FDA-appr Continue reading >>

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