Latex-containing packagings

The Pharmacovigilance Office of the Italian Medicine Agency (AIFA) required all pharmaceutical companies to check that a warning regarding the presence of latex rubber in the primary packaging material or in medical devices supplied with some medicines is duly reported in the PIL of medicinal products.

The warning, provided for by the guideline Excipients in the label and package leaflet of medicinal products for human use, is the only way to protect patients suffering from allergies to latex. Italian hospitals have recently reported cases of latex-related anaphylactic shock and the AIFA pointed out that, although latex is not considered as an excipient, it is often contained in vials’ stoppers or in plungers of pre-filled syringes.

The warning states the following: “The container of this medicinal product contains latex rubber. May cause severe allergic reactions”.

In case such warning is not reported, the Company will have to submit a variation application to the Competent Authority as soon as possible, in any case no more than 30 days from the receipt of this communication, according to Regulation EC no. 1234/2008, in order to include this warning in the PIL.

Red yeast rice: alert from France

The French Agency has launched an alert on food supplements containing red yeast rice, often labelled with claims on control of blood cholesterol. 

The Agency underlined that although containing monacolin K (also known as lovastatin) showing the same chemical characteristics of statins, products containing red yeast rice should not replace the therapies prescribed by the physician against cholesterol. Besides, after some reports of adverse events related to the use of such supplements, they should not be recommended to patients already under pharmaceutical treatment. 

These reports led to a review by ANSES (the French food safety agency) which assessed all the risks due to the consumption of these supplements. For the moment only few cases were reported, but the undesirable effects detected were similar to those listed for statins used in pharmaceutical products, such as increased frequency of muscular pain and increased hepatic enzymes with signs of jaundice. 

Therefore, the Agency has warned patients against the replacement of anti-cholesterol therapies with food supplements containing red yeast rice, especially in case of statin intolerance, since the undesirable effects are the same. Patients already treated with an anti-cholesterol therapy or receiving medicinal products interacting with statins should not take these supplements. Also grapefruit and grapefruit juice consumption should be avoided since this can increase the exposure to lovastatin with consequential overdose risk. 

Finally, patients were reminded that the therapy for hypercholesterolemia should always be accompanied by an appropriate low-fat regime and physical exercise.