change in licence terms
UK regulator caution on Valproate
To protect public health, the United Kingdom’s Medicines and Healthcare products Regulatory Agency has changed the licence for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of child-bearing potential unless they are on the pregnancy prevention programme (PPP), it said. Valproate is a treatment for epilepsy and bipolar disorder. Children born to women who take valproate during pregnancy are at significant risk of birth defects and developmental disorders.
crackdown on cholera
Largest vaccine drive
A spate of cholera outbreaks across Africa has prompted the largest cholera vaccination drive in history, with more than two million people across the continent set to receive oral cholera vaccine (OCV), the World Health Organisation said. The vaccines, funded by Gavi, the Vaccine Alliance, were sourced from the global stockpile and are being used to carry out five major campaigns in Zambia, Uganda, Malawi, South Sudan and Nigeria. The campaigns will be completed by mid-June.
non-surgical option
FDA okays new endoscopic device
The US Food and Drug Administration has permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. “The device provides a non-surgical option to treat upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed,” said Binita Ashar, in the FDA’s Center for Devices and Radiological Health.
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