Featured Items: pregabalin (Lyrica) approved for neuropathic pain in spinal cord injury; gabapentin enacarbil (Horizant) approved for postherpetic neuralgia; OPANA ER conversion to crush-resistant tablets; supplement Reumofan-Plus recalled for undeclared drugs.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.
Pregabalin (Lyrica® Capsules CV) - Approved for Neuropathic Pain Associated with Spinal Cord Injury
U.S. Food and Drug Administration officials gave Pfizer a June 2012 approval to market Lyrica Capsules CV for the management of neuropathic pain associated with spinal cord injury. A priority review was granted for this indication following 2 randomized, double blind trials in more than 350 patients comparing flexibly-dosed pregabalin — 150 mg/d to 600 mg/d — with placebo. The studies, which primarily treated patients with traumatic spinal cord injuries, also included a small number of nontraumatic spine-injured patients. Results showed significant reductions in neuropathic pain between baseline and trial end (12 or 16 weeks depending on the study protocol) for treated patients compared with those receiving placebo. Some treated patients experienced significant pain relief at week 1 that continued throughout the trial, and more patients receiving pregabalin reported 30% to 50% reductions in pain than placebo participants. Treatment was also associated with improved sleep and reduced anxiety. Common adverse effects for pregabalin were somnolence, dizziness, dry mouth, fatigue, and peripheral edema. Healthcare providers should advise patients that antiepileptic drugs, including pregabalin, can increase the risk of suicidal thoughts or behaviors. See the Lyrica Prescribing Information and Medication Guide for full administration and safety instructions.
Gabapentin Enacarbil (Horizant®) –Approved for Postherpetic Neuralgia
GlaxoSmithKline and Xenoport, makers of Horizant Extended-Release oral tablets, announced the June 2012 FDA approval of their extended-release gabapentin enacarbil for the adult treatment of postherpetic neuralgia. Because the pharmacokinetics of Horizant differ from other gabapentin drugs, the two products are not interchangeable. One 12-week safety and efficacy trial and 2 supportive studies in a total of 570 patients in 3 countries met primary endpoints for pain reduction. The drug is initially prescribed at 600 mg daily for 3 days, then increased to 600 mg twice daily beginning on day 4. Patients with impaired renal function must be evaluated for potential dose adjustments. The most commonly reported adverse effects were somnolence, dizziness, and headache. Dosing should be reduced for 1 week prior to discontinuation to minimize the risk of a withdrawal seizure. Healthcare providers should advise patients that antiepileptic drugs, including gabapentin enacarbil, can increase the risk of suicidal thoughts or behaviors. Horizant Extended-Release is available in 300 mg and 600 mg tablets. For complete administration and safety information, see the Medication Guide and Prescribing Information.
Opana ER – Complete Conversion to Crush-Resistant Tablets
Endo Health Solutions made a June 2012 announcement that all strengths of the original formulation of OPANA ER have been replaced by the newer crush-resistant tablet. While the tablets have been designed to resist tampering, the active ingredient oxymorphone remains the same and OPANA ER is available in 5 mg, 10 mg, 20 mg, and 30 mg dosages. The old formulation has been discontinued. The full Prescribing Information and Medication Guide can provide administration and safety data.
Reumofan-Plus Recall — Undeclared Drug Ingredient
In June 2012, the FDA notified patients and healthcare professionals that Reumofan-Plus, manufactured in Mexico by Riger Naturals, contains several active pharmaceutical ingredients not shown on the label. The product is sold in retail stores and on the internet as a dietary supplement for pain relief as well as a treatment for arthritis, osteoporosis, bone cancer and other disorders. FDA laboratory analyses identified that Reumofan-Plus contained diclofenac sodium, an NSAID, which can increase the risk of gastrointestinal bleeding, ulceration, or perforation. The product also contained methocarbamol, a muscle relaxant that can cause dizziness, low blood pressure, or enough sedation to cause mental or physical impairment. Reports of adverse effects — including liver injury, sudden changes in glucose control, leg cramps, and swelling — have been reported to the FDA in association with the use of Reumofan-Plus. Healthcare providers are encouraged to ask patients who use this product to stop using it and evaluate patients for drug interactions or adverse effects. See the Recall Announcement for additional information and a MedWatch reporting form.
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3 comments:
I know hundreds of pain patients. Every person that I have spoke with about the new Opana ER says it is in effective since the new formula change. This a a lot of people. It unfortunate that Opana ER will not be making the money they once did. The new formula oxycontin is not as effective either but the Opana is down right horrible. They are so hard, that it seems they do desolve in the stomach or the intestines. I have heard reports of them being expelled in the stool whole. Not ghost coatings. I mean whole. So, don't waste money, good money on this medication. This has been ruined. I have also heard of reports of this medication causing edema, indigestion, and nausea. Nausea in a way that they have never had with this medicine before. The formula before was not injectable and actually worked very well for chronic pain. So save your self some pain and money, don't even try it. You will be right back at the doctor in less than a week. It's a real shame that we are now catering to addicts instead of patients. If medications are not made effectively, we are going to be in a lot of pain in near future.
I had to change to Opana because of my pain doctor. The medication made me so sick, I ended up at the emergency room!! The doctor kept telling me that I was going through withdrawal. It wasn't withdrawal, but I had to call Endo Pharmaceuticals and talk to their pharmacist to find out that I had to be OFF of their medication ASAP!! This is what the DEA has done to pain patients. I can also no longer take Oxycontin which was a miracle drug for me for years. Now I have horrible reactions to the "new" formulations. Pretty soon, there will be NO pain medication that doesn't have new "crush proof" formula's REGARDLESS of what it does to a human life!! Who cares about the millions of pain patients who are suffering because of the DEA!!
All I know is that when I first started taking Oxycontin, life changed for the better. It was the first time I and slept through the night (well.... 5 straight hours), in YEARS! I couldn't believe how much better I felt. I had a steady state of medication in me, but didn't feel "medicated" at all. I had NO side effects. I couldn't BELIEVE how much my pain had decreased, and how much more I could do. Prior to that, just get g out of bed was at least a 30 minute process & I usually couldn't have a conversation with anyone for a while. Even though I was taking medication for pain, mornings were particularly BRUTAL for me. THEN....something awful happened. I had NO idea that the medication had changed, as the pills were the same color, and size. I spent almost three months SICK as a dog. I had severe stomach pain, headaches, anxiety, sleeplessness, BOWEL incontinence (first time EVER), and was irritable and depressed. I thought I was really sick, or had caught a strange virus. FINALLY, when talking to my doctor who prescribes my medication, I starting crying, telling him something was WRONG with me. SO, thankfully, he called my pharmacist right then. I told him the weekend that it all started. Well...guess what? I had picked up my first RX of the new formula on a Friday (almost 3 months prior), and my symptoms started the next day! So, that was it. The pharmacist told him that I was not alone in my suffering. Almost all of his customers on it, had complained of bad symptoms. I have been off of it since. I called the pharmaceutical company, and the FDA. Both sent me letters telling me that they were sorry to hear that I "perceived" the medication that way.....blah blah. My pain hasn't been controlled as well since. SO..... The media only talks about "narcotics", "deadly painkillers" , and all the abuse of them, and the pharm companies change their medication to better suit the abusers! What is wrong with this picture?
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