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21 July 2011 /Side effects and trials
Update on Pandemrix® and narcolepsy
As mentioned in the announcement from 30 June, the case about Pandemrix® and narcolepsy was to be re-evaluated by the member states' experts at the meeting in the European Medicines Agency (EMA), this week. The latest evaluation has resulted in the following recommendation: Pandemrix® should not be used in persons under the age of 20 unless there is no seasonal flu vaccine that protects against influenza H1N1. In Denmark, the seasonal flu vaccine will protect against influenza H1N1.
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21 July 2011 /Side effects and trials
EMA recommends to restrict the use of a particular diabetes medicine
The European Medicines Agency EMA reacts to information stating that diabetics who are treated with the medicine pioglitazone have a slightly increased risk of bladder cancer.
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21 July 2011 /Side effects and trials
EMA concludes benefits of the smoking cessation product Champix® (varenicline) still outweigh risks
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has assessed a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiovascular events.
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11 July 2011 /Side effects and trials
Electronic clinical trial applications do not meet format requirements
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility. Unfortunately, quite many of the applications do not comply with the requested format.
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11 July 2011 /Side effects and trials
New list clarifies requirements for amendments to clinical trials
The Danish Medicines Agency receives many questions regarding which amendments to clinical trials are to be notified to the Danish Medicines Agency, in particular because the European guideline CT 1 has been revised.
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11 July 2011 /Side effects and trials
Acne product isotretinoin not to be used during pregnancy
Women of child-bearing age must not use the acne product isotretinoin, unless a number of criteria are met. This contraindication has been in force since 2003 and applies to all medicines with the active substance isotretinoin. Even so, it still occurs that women fall pregnant even though they are treated with isotretinoin. A recent European report shows that since 2003, the European database of side effects has received reports of more than 80 pregnancies involving the original isotretinoin product (Roaccutan®, no longer marketed in Denmark) and several hundreds of pregnancies involving all isotretinoin products (Roaccutan® as well as generic versions).
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07 July 2011 /Side effects and trials
Risk of the rare but serious adverse reaction methemoglobinemia from the use of benzocaine-containing products used to relieve teething pain
Following a review of data, the U.S. Food and Drug Administration (FDA) has warned against the use of medicines containing the local anesthetic benzocaine in children less than two years of age. The reason is the risk of the rare but potentially serious adverse reaction, methemoglobinemia.
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06 July 2011 /Side effects and trials
Recent study suggests risk of cardiac events associated with the smoking cessation product Champix® (varenicline)
The Danish Medicines Agency is aware of a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiac events.
