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Meta
Category Archives: EMEA
Bevacizumab (Avastin) and breast cancer
After reviewing all available data relating to the use of Avastin to treat metastatic breast cancer, the FDA has decided the risks of bevacizumab outweigh its benefits in breast cancer. They are recommending the loss of the breast cancer indication: … Continue reading
Sibutramine withdrawn (Reductil)
Sibutramine has been withdrawn. The European-wide review of the anti-obesity drug sibutramine (Reductil) has concluded and an opinion reached recommending the suspension of the licence for the medicine across Europe. Evidence suggests that there is an increased risk of non-fatal … Continue reading
Efalizumab (Raptiva): Recommendation to suspend marketing authorisation
The MHRA reports on an EMEA decision on Efalizumab (Raptiva): The European Medicines Agency has completed a review of efalizumab (Raptiva) after concerns about its safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the … Continue reading
Rimonabant (Accomplia®) withdrawal
Rimonabant’s marketing licence has been suspended by the Eurpean Medicines Evaluation Agency because of an increased risk of psychiatric disorders, and concerns about its effectiveness: Following the assessment of the available information on the benefits and risks of Acomplia including … Continue reading
Varenicline (brand name Champix) European wide review
EMEA have issued a warning about suicidal ideation and suicide attempts associated with varenicline [PDF]: The European Medicines Agency (EMEA) has concluded that updated warnings to doctors and patients are needed to increase awareness of cases of suicidal ideation and … Continue reading
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Withdrawal of lumiracoxib
EMEA have withdrawn lumiracoxib from the European market due to its effects on the liver [PDF]: The liver safety of lumiracoxib has been monitored continuously since its launch in 2005. In August 2007, the product information was updated with contraindications … Continue reading
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Thiazolidinedione safety
Following review, The European Medicines Agency has concluded that the benefits of the thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) continue to outweigh their risks in the approved indications. They have also suggested that further studies should be carried out in … Continue reading
Aprotinin (Trasylol®): UK licences suspended
The Commission on Human Medicines (CHM) has now advised that the UK marketing authorisations (licences) should be suspended pending the outcome of a full Europe-wide review of the balance of risks and benefits of aprotinin . This review is expected … Continue reading
Strontium ranelate (Protelos) and severe allergic reactions
The MHRA have responded to the European Medicines Agency statement on strontium ranelate: Women taking Protelos should be alert to the risk of severe allergic reactions and if they develop a rash, they should stop taking the medicine and consult … Continue reading
lumiracoxib (Prexige) and the liver
Following consultation with the MHRA and other European regulators, the manufacturer of the osteoarthritis drug lumiracoxib (Prexige), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. Concern was raised worldwide after rare reports … Continue reading