Japan's MLHA calls for PI revisions for SSRIs and SNRI

Japan's Ministry of Health, Labor and Welfare says that the Pharmaceutical and Medical Device Agency has investigated the causal  relationship between three selective serotonin reuptake inhibitors, one  serotonin norepinephrine reuptake inhibitor and aggressive behaviors  including excitement, aggression and irritability as adverse reactions.  As a result, the MHLW recommends that package inserts of SSRIs,  including GlaxoSmithKline's Paxil (paroxetine), Pfizer's Zoloft  (sertraline), Meiji Seika's Depromel and Astellas' Luvox (fluvoxamine),  and one SNRI, Asahi Kasei Pharma/ Janssen Pharma's Toledomin  (milnacipran) should be revised to draw attention to the possibility of  these ARs.

Teruhiko Higuchi, president of Japan's National Center of Neurology and  Psychiatry, who attended the meeting as a witness, said that a committee  within the Japan Society of Mood Disorders will discuss ways of  promoting proper use of antidepressants and providing physicians and  patients with appropriate information in collaboration with the MHLW.

Last December, Bayer Yakuhin, the Japanese subsidiary of Germany's Bayer  HealthCare, revised the precautions in the package insert for Nexavar  (sorafenib), a treatment for renal cell cancer, because four cases of  acute pulmonary disturbances, including two of interstitial pneumonia,  were reported among about 2,000 events from April through December 2008.  These occurred after a six-month post-marketing survey.