March 12, 2013 | By Márcio Barra
The Pharmacovigilance Risk Assessment Committee has issued the meeting highlitghts from their 4-7 March 2013 reunion, where safety reviews where the main topic at hand.
In short, EMA’s review of Diane 35 and its generics is still ongoing, and four new safety reviews started in this meeting, bringing the number of referrals started by the PRAC to a total of 17 ever since it started its operations.
The following products will be reviewed: Kogenate Bayer, Helixate Nexen, Domperidone – containing medicines, Flupirtine – containing medicines and nicotinic acid and any related substances.
The review of Kogenate Bayer and Helixate Nexen (from Bayer Pharma AG), two medicines containing human coagulation factor VIII (octocog alfa), a protein needed to form blood clots, will be conducted to assess in light of new information as whether the benefits of these drugs still outweigh their risks in patients with Haemophilia A, a bleeding disorder. This review was due to recent results from a study done in 574 untreated children with haemophilia A, who were given different factor VIII drugs. The study showed that children who were given second generation factor VIII drugs like Koenate and Helixate were more likely to develop antibodies than those who were given third generation products like Advate from Baxter.
The review of Flupirtine – containing medicines was prompted by the German medicines regulatory agency after reports of an increasing number of liver problems associated with the use of flupirtine, from asymptomatic to full blown liver failure. The German agency also expressed concerns over the lack of data supporting the effectiveness of flupirtine in the relief of long term pain. Flupirtine is an aminopyridine, a centrally acting non-opioid, non-NSAID, non-steroidal analgesic, which works by opening potassium channels on the surface of nerve cells, reducing the excess of electricity that leads to pain. Flupirtine-containing medicines are all authorized nationally, and so the PRAC recommendation will be sent to the Co-ordination Group for Mutual Recognition and Decentralized Procedures – human (CMDh).
As for domperidone, it’s a substance found in many over the counter medicines like Motilium (Janssen), Mirax (Berlin), and Domper (Opalia, YSP, and Yung Shin), used to relive symptoms of nausea and vomiting, fullness, abdominal discomfort and heartburn. Owing to concerns of adverse effects on the heart, like QT prolongation and arrhythmias, the Belgian medicines agency stated that drugs containing domperidone should no longer be used on patients with certain heart conditions, and requested a risk-benefit evaluation from the PRAC. It’s worth noting that The US Food and Drug Administration (FDA) has not approved domperidone for any indication, under safety concerns.
The review of nicotinic acid and related substances acipimox and xantinol nicotinate is the big one here, after the HPS2-THRIVE results, presented at the ACC in San Francisco this past saturday. Back in January EMA withdrew Merck’s Tredaptive marketing authorization over safety concerns. This new review follows new data revealed from the study which found that the combination of nicotinic acid and laropiprant did not reduce the risk of major vascular events, and was in fact associated with a higher frequency of non-fatal but serious side effects. Follow this link for more information, or read this excellent article by Matthew Herper.