Here are some current short drug & patient safety news for your quick reference:
• FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia
• MHRA recommend against concomitant use of St John’s wort and all antiepileptics
• Fibrates:new prescribing advice from MHRA
• Ceftriaxone: incompatibility with calcium-containing solutions

• FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia
Agency says drug to remain on market, while safety assessment continues. The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

For more information:
www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

• MHRA recommend against concomitant use of St John’s wort and all antiepileptics

In the most recent issue of its Drug Safety Bulletin, the MHRA has reminded healthcare professionals that any antiepileptic medicine may interact with St John’s wort, and that their concomitant use is therefore not recommended.

The first warnings that some antiepileptic medicines interacted with St John’s wort were issued in 2000; these were based on the metabolism of these medicines and the known induction and inhibitory effects of St John’s wort on various cytochrome P450 enzymes. The MHRA has continued to receive reports of possible interactions between antiepileptics and St John’s wort, including those previously not known to interact. The Herbal Medicines Advisory Committee and the Commission on Human Medicines Pharmacovigilance Expert Advisory Group have considered the interaction between St John’s wort and antiepileptic medicines by routes other than the recognised cytochrome P450 pathway, and both have recommended that the current warnings about interactions should extend to include all antiepileptic medicines.

St John's wort preparations have shown efficacy in treating clinical depression. Several studies and meta-analyses have found it to be effective in the treatment of mild to moderate depression, with fewer side effects than many conventional antidepressants. Other studies, including a major NIH study that focused on moderate to severe depression, have shown no improvements.

• Fibrates:new prescribing advice from MHRA

Keywords: bezafibrate, fenofibrate, gemfibrozil, ciprofibrate, statins, lipids,triglycerides, cholesterol, cardiovascular disease, risk-benefitKey message:Fibrates should be used as first-line therapy onlyin patients withisolated severe hypertriglyceridaemia. In patients who also have raised cholesterol,fibrates may be considered only when a statin or other effective treatments arecontraindicated or not tolerated.

Advice for healthcare professionals:

• Fibrates should be considered as first-line therapy only in patients withisolated severe hypertriglyceridaemia
• For patients with mixed hyperlipidaemia, fibrates may be used only when astatin or other effective treatments are contraindicated or not tolerated
• In patients with primary hypercholesterolaemia, the use of gemfibrozil may beconsidered, but only when a statin or other effective treatments arecontraindicated or not tolerated
• Combination therapy with a statin and a fibrate should be used with cautionand only when the benefits are expected to outweigh potential risks.
• Avoidconcomitant use of gemfibrozil with a statin.

• Ceftriaxone: incompatibility with calcium-containing solutions

Keywords: ceftriaxone, Ringer’s, Hartmann’s, incompatibility, precipitation, calcium,neonate, newborns, contraindicated.

Key message: Ceftriaxone is contraindicated in newborns who need calcium treatment. It should not be mixed with, or given at the same time as, calcium-containing solutions because of a risk of calcium precipitation.

Advice for healthcare professionals:

• Ceftriaxone is contraindicated in newborns who need calcium treatment because of a risk of precipitation of ceftriaxone–calcium salt 
• In all patients, ceftriaxone must not be mixed with calcium-containing solutions, and must not be given to any patient simultaneously with calcium-containing solutions—even via different infusion lines

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