Is Extended-Release Lyrica Any Safer For Nerve Pain Patients Than The Versions Before It?

Today's short but slightly alarming post from pharmacytimes.com (see link below) reveals that the American FDA has approved a new, slow-release and once daily version of pregabalin (Lyrica) for certain types of neuropathic pain (diabetic neuropathy and post-herpetic neuralgia) but not for others. Now despite the many law suits surrounding side effects and the FDA's own rejection in 2013 of pregabalin for most types of neuropathy, Pfizer will regard this as a major victory. The danger is however, that doctors who may have begun to have their doubts may now see this as blanket approval of Lyrica for all types of neuropathy displaying the same symptoms and continue prescribing it on the scale they did before. The tests and trials were short-term and addressed pain reduction but didn't look at side effects, or the effects of long term use, that have been so damaging for Pfizer in the past. If you follow the link to Pfizer's own report of this new approval of the once daily drug, you'll see the following:

Important Safety Information
Prescription LYRICA CR is not for everyone. Patients should tell their doctor right away about any serious allergic reaction that causes swelling of the face, mouth, lips, gums, tongue, throat, or neck or any trouble breathing, rash, hives, blisters or skin redness. LYRICA CR may cause suicidal thoughts or actions in a very small number of people. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If patients have suicidal thoughts or actions, they should not stop LYRICA CR without first talking to their doctor. LYRICA CR may cause swelling of the hands, legs and feet. Some of the most common side effects of LYRICA CR are dizziness and sleepiness. Patients should not drive or work with machines until they know how LYRICA CR affects them. Other common side effects are tiredness, headache, nausea, blurry vision, weight gain, and dry mouth. Also, patients should tell their doctor right away about muscle pain along with feeling sick and feverish, or any changes in eyesight including blurry vision or any skin sores in patients with diabetes. There may be a higher chance of swelling, hives or gaining weight in patients also taking certain diabetes or high blood pressure medicines. Patients should not drink alcohol while taking LYRICA CR. Patients may have more dizziness and sleepiness if taking LYRICA CR with alcohol, narcotic pain medicines, or medicines for anxiety. Patients who have had a drug or alcohol problem may be more likely to misuse LYRICA CR. Patients should tell their doctor if planning to father a child, if pregnant, or planning to become pregnant. Breastfeeding is not recommended while taking LYRICA CR. Patients should talk with their doctor before they stop taking LYRICA CR or any other prescription medication.

Now the question you have to ask yourself is this: having read their own warnings, do you feel confident taking this drug? It must be worth at least a serious discussion with your doctor!

FDA OKs Pregabalin Extended-release Once-Daily Tablets for Neuropathic Pain
OCTOBER 12, 2017

Officials with Pfizer have announced that the FDA has approved pregabalin (Lyrica) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). The tablets did not get approval for managing fibromyalgia, however, according to a press release from Pfizer.

The efficacy and safety of the tablets was established in a randomized placebo-controlled clinical trial conducted in 801 patients with PHN who entered single-blind treatment. As both pDPN and PHN are peripheral neuropathic pain conditions, the PHN data was supportive of both the pDPN and PHN indications.

The randomized trial included a 6-week single-blind, dose optimization phase followed by a 13-week double-blind phase. In the PHN study, 73.6% of patients in the LYRICA CR group achieved at least a 50% improvement in pain intensity compared with 54.6% in the placebo group.

The most common adverse reactions reported with LYRICA CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.

Reference

U.S. FDA APPROVES LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS CV [news release]. Pfizer website. http://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv. Accessed October 12, 2017.

http://www.pharmacytimes.com/product-news/fda-oks-pregabalin-extendedrelease-oncedaily-tablets-for-neuropathic-pain-