LYRICA SIDE EFFECTS AND INDICATIONS
Lyrica (pregabalin) capsules is
FDA-approved to treat painful
peripheral neuropathy and
postherpetic neuralgia - the two
most common forms of
neuropathic, or nerve pain.
LYRICA INDICATIONS

In June, 2005, Lyrica was approved by FDA for a new use which is to treat partial onset
seizures in adults with epilepsy. Pregabalin (Lyrica) was approved by FDA for the
management of diabetic peripheral neuropathy and postherpetic neuralgia in December
2004.

PREGABALIN (LYRICA) CLINICAL TRIALS

Pregabalin (Lyrica)  was tested in three trials including nearly 1,000 patients. Before the
treatment with pregabalin (Lyrica), patients had approximately 10 seizures a month,
even though they were taking one to three other antiepileptic medications. During the
Pregabalin (Lyrica) treatment, their frequency of partial seizures was roughly cut in half,
with a 51% reduction.

PREGABALIN (LYRICA) SIDE EFFECTS

The most common side effects in Lyrica's trials were dizziness, sleepiness (somnolence),
dry mouth, peripheral edema, blurred vision, weight gain, and difficulty with
concentration/attention.

PREGABALIN (LYRICA) PHARMACOKINETICS SUMMARY

Plasma and/or tissue concentrations were determined in mice, rats, and monkeys
following Pregabalin (Lyrica) administration. Pregabalin (Lyrica)  was found to be rapidly
absorbed in animals and mainly excreted in urine as unchanged. Pregabalin (Lyrica)  
renal clearance and volume of distribution in humans are well predicted by pre-clinical
species. A minor metabolite in mouse and rat urine was identified as the N-methyl
metabolite. In dogs, approximately 45% of the pregabalin (Lyrica)  dose was excreted in
urine as N-methyl metabolite. No significant inhibition of human CYP1A2, 2A6, 2C9,
2C19, 2D6, 2E1, or 3A4 was observed in vitro at Pregabalin (Lyrica)  concentrations up
to 1000 mM, suggesting low probability for Pregabalin (Lyrica)  to elicit drug-drug
interactions through inhibition of CYP450 isozymes.

Pregabalin (Lyrica)  exhibited potent activities in rats in the maximum electroshock seizer
test for epilepsy, in chemical allodynia models for neuropathic pain, and in Vogel conflict
test for anxiety. The estimated EC50 values ranged from 1.9 ?3.7 mg/mL in the  rat
models, which are consistent with the steady state average Pregabalin (Lyrica)  
concentrations (1.6 - 5.6 mg/mL) in humans at efficacious doses of 150 - 600 mg/day. [2]

POSSIBLE ADVERSE EFFECTS AFTER WITHDRAWAL FROM LYRICA (PREGABALIN}

A case of brain swelling, or cerebral edema, after abrupt withdrawal from pregabalin
(Lyrica) was reported. [1] In a study testing the drug for the severe pain of shingles, or
postherpetic neuralgia, a 80 year old female patient suffered nausea, headache and
loss of balance after abruptly discontinuing the drug. A week later, she started to
experience hallucinations and delirium. Researcher found swelling in the same part of
the brain that is affected in some epileptic patients who also suddenly stop their
medications. However, a single case can not constitute proof of these adverse effects
linked to the abrupt withdrawal of the Lyrica (pregabalin). It might be just coincidental.
Anyway, when a patient stops an medication, he or she should stop it under physician
guidance. [1]

DOSING

Lyrica can be given to patients two or three times a day. It's classified as a controlled
substance.

REFERENCES

[1] NICHOLAS BAKALAR Case Raises New Concern Over Withdrawal of Drugs The New
York Time.Com July 19, 2005 [2] R. Feng et al, Pregabalin: Pharmacokinetics,
Pharmacodynamics and Interspecies Scaling FDA Abstract Review Board Number: A-17
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