Children born to mothers who used SSRI (selective serotonin reuptake inhibitors) antidepressants during pregnancy may be at a higher risk of speech or language disorders. Researchers examined data on more than 845,000 births in Finland. The mothers of the children were divided into 3 groups: Those who purchased an SSRI during pregnancy; those diagnosed with a mental illness 1 year before or during pregnancy but did not purchase an antidepressant; and those with no mental illness who never used an antidepressant. Mothers who purchased antidepressants at least twice during their pregnancy had a 37% increased risk of speech or language disorders in their offspring compared with mothers in the other 2 groups. Posted October 12, 2016. Via JAMA Psychiatry.
The FDA has approved a new biologic treatment, Lartruvo (olaratumab), for the treatment of soft tissue sarcoma. The approval is the first for a front-line soft tissue sarcoma drug in 40 years. Lartruvo, an injection, is designed to be given in combination with doxorubicin, a common chemotherapy agent. Lartruvo was given fast-track status and granted accelerated approval by the FDA based on 1 Phase II trial. Eli Lilly, Lartruvo’s developer, will need to conduct a Phase III trial while the biologic is on the market to confirm its efficacy. Lartruvo does carry some serious risks, including infusion-related reactions and embryo-fetal harm. Posted October 19, 2016. Via FDA.
The FDA is looking into the deaths of 10 infants that may be tied to the use of teething tablets and gels. The development comes just weeks after the agency issued a safety alert warning parents not to use the products due to potential side effects including difficulty breathing and even seizures. The tablets are produced by companies including Hyland’s and CVS. CVS has said it has pulled all products from its shelves and Hyland’s has stopped distributing teething tablets and gels. In 2010, an FDA analysis found inconsistent amounts of belladonna, a plant that has sedative properties, in Hyland’s tablets. Posted October 18, 2016. Via The New York Times.