Here are 2 summaries of the safety news for your quick update & further reading.
• Risk of Birth Defects – Valproate Sodium & Related Products
• Diclofenac Sodium 1% Topical Gel - Labelling Changes on Hepatic Effects
• Risk of Birth Defects – Valproate Sodium & Related Products
On Dec 3, 2009, The US FDA notified health care professionals & patients about the increased risk of neural tube defects & other major birth defects, such as craniofacial defects & cardiovascular malformations, in babies exposed to valproate sodium & related products (valproic acid & divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, & consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.
Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits & risks of valproate & encourage patients to discuss options with their healthcare professional.
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• Diclofenac Sodium 1% Topical Gel - Labelling Changes on Hepatic Effects
The US FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings & precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with & without jaundice, & liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first & subsequent transaminase measurement are not known. Based on clinical trial data & postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.
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