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Paxil (paroxetine hydrochloride hydrate)：　Submission of a written request entitled “Revision of the Package Insert and Need of Patient Information Leaflets on Antidepressant Paxil Tablets for Pregnant Women.”

2009-10-21

Paxil antidepressant tablets (manufactured and distributed by GlaxoSmithKline K.K.) are a type of SSRI (selective serotonin reuptake inhibitor) which came out on the market in November 2000 in Japan. It is now widely used as an antidepressant, and was the top-earning antidepressant in the Japanese market (50 billion yen) in 2007.

However, if a pregnant woman is treated with Paxil during her first trimester, there is a high risk of congenital anomalies, particularly cardiovascular disorders (primarily ventricular septal defects and atrial septal defects). Also, if Paxil is taken after 20 weeks of her pregnancy, there is a data showing that the risk of drug withdrawal syndrome and persistent pulmonary hypertension in newborns increases.

Given that women only notice their pregnancy after first trimester passes, and that patients are inclined to be dependent on Paxil, women who are pregnant or those at child-bearing age should not, as a general rule, take this medication, and should not start treatment unless no alternative treatment is available.

In addition, even if it is inevitable to treat patients with Paxil, the patient's informed consent should be obtained after a full explanation of the dependency and the risk of congenital anomalies in newborns.

Therefore, in October 2009, we sent a request letter entitled "Revision of the Package Insert and Need of Patient Information Leaflets on Antidepressant Paxil Tablets for Pregnant Women" to GSK and the MHLW.


<　Our Request Outline　>

1.　The Warnings section of the package insert should be revised to include the above risks

2.　Patient Information Leaflets should be provided at medical practice in order to call sufficient attention to the risks in newborns; and

3.　 A research group to look into the data on the use of Paxil by pregnant women, as well as any related facts concerning cardiac malformations in newborns should be established.