A commonly prescribed tablet to treat asthma in children has been linked to psychiatric effects, including instances of suicidal thoughts and depression based on case reports in Australia. Between January 2000 and March 2016, the country’s Therapeutic Goods Administration received almost 90 reports of psychiatric adverse events in children and adolescents taking Singulair (montelukast). Among these were 8 patients with suicidal thoughts and 8 cases of patient depression. The labeling for Singular in the US includes a warning that neuropsychiatric events have been reported with the drug and patients should be on alert to recognize them. It goes on to note that post-marketing reports of Singular include instances of agitation, aggressive behavior, hallucinations, irritability, depression and suicidal thinking. Posted September 5, 2016. Via Australian Broadcasting Corporation.
Many antibacterial soaps sold to consumers will become unavailable after the FDA determined that they are not proven to be effective and may even be harmful. The agency’s final rule, which goes into effect on September 6, 2017, bans 19 active ingredients, including two of the most popular, triclosan and triclocarban. The FDA said it is instituting the ban because the manufacturers did not demonstrate the ingredients are safe for long-term use and are more effective than plain soap and water. The rule does not impact hand sanitizers or wipes. The rule was first proposed in 2013 after the FDA received reports that soaps containing the ingredients could lead to antibacterial resistance or hormonal effects. Posted September 2, 2016. Via FDA.
The FDA is telling women to avoid ovarian cancer screening tests since it may give them a false sense of security. The tests are said to help predict whether a woman may be at risk for or have ovarian cancer based on a levels of certain proteins in the blood. However, the FDA says that no such test is reliable, leading to false-positive or false-negatives. As a result, women may either get unnecessary treatment, including surgery, or avoid actions that could mitigate future risk. Women at menopause, who have a family history of ovarian cancer, and certain genetic mutations have the highest risk for developing ovarian cancer. Posted September 7, 2016. Via FDA.