Methylphenobarbital (INN), also known asmephobarbital (USAN,JAN) andmephobarbitone (BAN), marketed underbrand names such asMebaral,Mephyltaletten,Phemiton, andProminal, is adrug which is abarbiturate derivative and is used primarily as ananticonvulsant,[2] but also as asedative andanxiolytic. It is theN-methylated analogue ofphenobarbital and has similar indications, therapeutic value, and tolerability.
1935 – Mebaral was introduced by Winthrop Pharmaceuticals.
2001 – Methylphenobarbital discontinued in the UK.
2003 – Mebaral was acquired by Ovation Pharmaceuticals (a specialty pharmaceutical company that acquired under-promoted branded pharmaceutical products).
2009 – Ovation was acquired byLundbeck, which now markets Mebaral.
2012 – Lundbeck announced that they were abandoning the product in the US as of January 6, 2012. The stated reason was because "the company thoroughly evaluated all avenues for keeping Mebaral available to patients, but ultimately concluded that no matter what steps they [i.e. Lundbeck] took, patients would be forced to transition to a new therapy."
The company further stated in a letter on its website[3] that under the FDA'sUnapproved Drugs Initiative, FDA is no longer willing to allow the drug to be grandfathered. Anew drug application would have needed to have been submitted to gain marketing approval, which would have taken an estimated five years, during which time patients would be required to change their therapies in any case. The last available tablets bore anexpiration date of March 31, 2012, and the drug will no longer be available in the US when supplies are depleted.[citation needed]
Symptoms of overdose of mephobarbital include confusion, decrease in or loss of reflexes,somnolence,fever, irritability, hypothermia, poor judgment, shortness of breath or slow/troubled breathing, slow heartbeat, slurred speech, staggering, trouble in sleeping, unusual movements of the eyes, weakness.
^Aksamija A, Habek D, Stanojević M, Ujević B (2009). "Fetal malformations associated with the use of methylphenobarbital and carbamazepine during pregnancy. Two case reports and review of the literature".Fetal Diagnosis and Therapy.25 (1):79–82.doi:10.1159/000201945.PMID19218807.
