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New rules for valproate by MHRA

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Valproate must no longer be pre-scribed to women or girls of childbearing potential unless they are on a pregnancy prevention programme, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

The agency has changed the license for valproate medicines in an effort to minimize the number of birth defects and persistent developmental disorders among children who were exposed to valproate in the uterus. According to MHRA, up to 40% of babies born to mothers who used valproate are at risk of developmental disorders. Around 10% of babies are at risk of birth defects.

By September 2018, a visual warning symbol will be added to valproate medicine packs. This will depict a pregnant woman in a red circle with a line through it, accompanied by warning text about the risks of valproate and information about the new regulatory measures. The MHRA is recommending that pharmacists dispense valproate in whole packs whenever possible, to ensure that patients see the warning symbol and receive the new information.

Packs of valproate medicines with a detachable patient card will start to be available from December 2018.

The MHRA's announcement, which comes into force on April 2018, follows the European Medi.cines Agency's endorsement, on 23 March 2018, of enhanced regulatory measures for valproate. The National Institute for Health and Care Excellence is also amending its valproate guidelines to reflect the new regulatory changes.

Source: The Pharmaceutical Journal [online, 24 April 2018].

New drugs in India

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The Central Drugs Standard Control Organization (CDSCO) has approved three new drugs for clinical use in the last month.

Cadexomer iodine topical powder and topical ointment has been approved for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic foot ulcers, infected traumatic and surgical wounds. In this formulation, iodine is impregnated in hydrophilic beads of cadexomer which allows a slow release of iodine into the wound and absorption of fluid, bacteria, and other substances from the wound.

Dalfampridine 10mg extended release tablets has been approved to improve walking in patients with multiple sclerosis (MS). Dalfampridine is a potassium channel blocker which improves conduction in focally demyelinated axons by delaying repolarization and prolonging the duration of action potentials. The drug is usually given in a dose of 10mg twice daily.

Ulipristal acetate 5mg tablet is the other drug approved by the CDSCO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermit-tent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal is a progesterone receptor modulator with antagonist and partial agonist effects. It inhibits or delays ovulation, alters the endometrial epithelium, and can reduce fibroid size.

Source: www.cdsco.nic.in [online, 10 Apr 2018]