Pregabalin (Lyrica) is moved to prescription group B

Pregabalin  –  prescription group B

The Danish Medicines Agency moves pregabalin from prescription group C to prescription group B from 1 June 2018. The purpose is to remind doctors about the risk of addiction when using pregabalin.

Pregabalin received marketing authorization in Norway in 2004. As early as 2007, 21,000 patients used pregabalin. The number of users has been stable.

Approved indications:
Peripheral and central neuropathic pain in adults. Additional treatment for epilepsy in adults with partial seizures with or without secondary generalization. Generalized Anxiety Disorder (GAD) in adults.

The Pharmaceutical Handbook states: “Pregabalin is a GABA analogue without direct GABA-erg effect. It works by binding to a component of voltage-dependent calcium channels in the CNS. There is a proven effect in focal seizures with or without generalization and neurological pain. Effect is also documented by anxiety states ».

The active substance was placed on the surveillance list in 2010 due to reports of addiction, abuse and discontinuation reactions. Following a comprehensive investigation, the Swedish Medicines Agency has decided that pregabalin is now moved to prescription group B.

Pregabalin on white prescription
When pregabalin becomes “B preparation”, it means that the doctor can no longer reiterate white prescriptions on the drug. As a transitional scheme, it is decided that rehearsal of pregabalin prescriptions issued before 1 June is still valid.

Pregabalin on “blue prescription”
Vesicles on pregabalin can be reiterated as before.
The blueprints issued before June 1 are still valid.
In the treatment of epilepsy, pregabalin is refunded as before on blue prescription (§2).
Individual benefits already granted from Helfo can still be used.

Application for individual benefit (§ 3) for new patients
It applies to your own requirements for individual benefit to addictive drugs. Following a change in prescription status, these requirements will mainly apply to pregabalin.

In the application for individual benefit for pregabalin, the doctor must document:

That the danger of addiction is considered.
That there is a plan for the treatment.
That pain analysis has been done (when the application concerns chronic pain).
Planned maximum daily dose.
In addition, the current terms and conditions for individual benefits will be continued. Among other things, this requirement applies to trying gabapentin first with strong neuropathic pain.

See ​​for more details about conditions for individual benefit to pregabalin.

The application must be obtained from the relevant specialist or doctor at the relevant hospital department. In the treatment of resolved chronic severe pain, the GP may also apply.

Pharmacy Advice:

– Inform patients about the background of the change in prescription status for pregabalin. Pregabalin prescriptions issued prior to 01.06.18 are still valid.
– After 1 June, the doctor can no longer reiterate white prescriptions.
– Vesicles on pregabalin can be reiterated as before.
Individual benefits already granted from Helfo are still valid.
– Pregabalin will then be subject to the same rules for storage and safety as for other drugs in prescription group B.

Advice for patients and relatives:

– Remember that a regular (white) prescription for pregabalin (Lyrica) is only valid for one extradition from 1 June 2018. Recipes issued before 1 June may be used as before.
– There are no changes for the delivery of pregabalin (Lyrica) on blue prescription. It can be collected for 1 year of use if the doctor decides.
– Individual benefits already granted from Helfo are still valid after 1 June 2018.

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Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

The Food and Drug Administration (FDA) has approved an expanded indication for Lyrica (pregabalin; Pfizer) to include adjunctive therapy for the treatment of partial onset seizures in patients as young as 4 years old.

The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4–<17 years of age. Compared with placebo, patients treated with Lyrica 10mg/kg/day had, on average, a 21% greater reduction in partial onset seizures (P= .0185), while those treated with Lyrica 2.5mg/kg/day had, on average, a 10.5% greater reduction (P= .2577).

In addition, the responder rate (≥50% reduction in partial onset seizure frequency), a key secondary efficacy parameter, was 40.6% for Lyrica 10mg/kg/day, 29.1% for Lyrica 2.5mg/kg/day, and 22.6% for placebo. Somnolence, weight gain, and increased appetite were found to be the most common adverse reactions associated with treatment.

Lyrica, a gabapentinoid, is also indicated for the management of: neuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; fibromyalgia, and neuropathic pain associated with spinal cord injury.

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Pregabalin and pregnancy

Pregabalin and pregnancy

Dear Dr. Roach • I’m 13 weeks pregnant, and I am on pregabalin (prescribed off-label for anxiety). I asked my GP if it is safe to continue to be on it while pregnant, and he was very dismissive and hurried me out the door without really telling me anything. I read about a very small study that was conducted that seemed to show a risk of birth defects, but due to its small size, it didn’t really help me either. I was wondering if you know anything about pregabalin and pregnancy. — G.H.

Answer • While I understand the demands of a busy practice, your physician should have found time to talk to you about this important issue.

A study from Boston in 2017 looked at a large database and found no statistically significant increase in major congenital abnormalities in women taking pregabalin during pregnancy, but it could not exclude the possibility of a small risk of a harmful effect. Anxiety itself isn’t good for the baby, so the best option would be treatment that is effective but at lowest risk.

In your case, given the large number of medicines for anxiety that are better studied in pregnancy, I would talk to your doctor about a different choice during pregnancy. Benzodiazepines (including Valium, Ativan and others) are seldom my first choice for anxiety, but they are the first choice among many experts in treating anxiety during pregnancy.

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Proposed Mechanism of Action

LYRICA is thought to help by rebalancing neurotransmitters—reducing substance P and glutamate levels and restoring the release of norepinephrine.

Pregabalin binds presynaptically to the alpha2-delta subunit of the voltage-gated calcium channels in central nervous system tissues located in the brain and spinal cord. The mechanism of action has not been fully elucidated but studies suggest that pregabalin produces a disruption of calcium channel traficking or a reduction of calcium currents. The inhibition of subunits of voltage-gated calcium channels reduces calcium release which in order inhibits the release of several neurotransmitters. Studies also suggest that the descending noradrenergic and serotonergic pathways originating from the brainstem may be involved with the mechanism of pregabalin. Interestingly, although pregabalin is a structural derivative of inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA or benzodiazepine receptors.

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Clinical studies

Clinical studies with Lyrica (pregabalin) in epilepsy

Clinical studies with oral Lyrica (pregabalin) suggest it is at least as effective as gabapentin as adjunctive therapy in patients refractory to one or more conventional antiepileptic drugs. In large-scale, placebo-controlled studies of 12 weeks’ duration, add-on therapy with oral Lyrica (pregabalin) reduced seizure frequency by up to 75%. In these studies doses of Lyrica (pregabalin) ranged from 150mg to 600mg daily.

Clinical studies with Lyrica (pregabalin) in neuropathic pain and anxiety disorder

Neuropathic pain is chronic pain that arises from damage to sensory nerves. It can include:

  • Pain arising from trapped or compressed nerves
  • Drug-induced nerve damage
  • Diabetic neuropathy
  • Post-herpetic pain
  • Phantom limb syndrome following limb amputation
  • Peripheral neuropathy
  • Fibromyalgia

Neuropathic pain generally does not respond to treatment with opioid or non-steroidal anti-inflammatory drugs (NSAIDs). At high doses gabapentin has proven effective against neuropathic pain induced by diabetic neuropathy and postherpetic neuralgia. Data from clinical studies show that Lyrica (pregabalin) shares this analgesic effectiveness. Efficacy has been demonstrated in a number of clinical studies, including those in patients with diabetic neuropathy and fibromyalgia. Treatment of neuropathic pain is seen as the drug’s leading indication.

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