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14 June 2011 | Updated 17 June 2011 /Side effects and trials
Risk of venous thromboembolism (blood clots) from use of 4th generation contraceptive pills
Women who use 4th generation contraceptive pills should read and follow the instructions of the package leaflet supplied with the contraceptive pills and contact their own doctor if unsure about the treatment.
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16 June 2011 /Side effects and trials
Problems with dispatching adverse reaction reports and acknowledgement messages (ACK) on 15-16 June
In connection with a clean up of failed adverse reaction reports Thursday morning 16 June 2011, some reports may have been dispatched more than once.
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16 June 2011 /Side effects and trials
Risk of heart malformations in children of mothers treated with an antidepressant of the SSRI type
Epidemiological studies have shown a small increased risk of malformations in the cardiovascular system in newborns of mothers who have taken antidepressants containing fluoxetine or paroxetine in the beginning of pregnancy. In addition, the Danish Medicines Agency has received a few reports of the same type of malformations from treatment with citalopram and sertraline. Physicians are advised to follow the applicable restrictive recommendations and carefully weigh the risks and benefits of using antidepressants during pregnancy and to consider prescribing the medicines in consultation with specialists within the field (psychiatrists and/or obstetricians).
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16 June 2011 /Side effects and trials
Guide to getting started in clinical research
The Danish Ministry of Interior and Health has published a guide to getting started in clinical research, which is intended to make it easier and more attractive to engage in clinical research in Denmark. The guide is in Danish, but an English version is under way, and will be posted here on this page as soon as it is available.
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10 June 2011 | Updated 14 June 2011 /Side effects and trials
Diabetes medicine withdrawn in France while awaiting EU review
Since March 2011, the EU has been engaged in reviewing the benefits and risks of diabetes medicines which contain the substance pioglitazone. Pioglitazone is being investigated due to suspicion of an increased risk of urinary bladder cancer. The French drug regulatory authorities have chosen to temporarily remove diabetes medicines that contain pioglitazone from the market, while we are awaiting the outcome of the EU review. In Denmark, the Danish Medicines Agency is awaiting an early, common EU decision on pioglitazone. Danish patients should not change their treatment at the present time.
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24 May 2011 /Side effects and trials
Ask your doctor for advice if you are in doubt about the use of antidepressants during pregnancy
Today, the Danish media have focused on pregnant women's use of antidepressants. If this has caused you to worry, the best thing you can do is to contact your doctor for advice.
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17 May 2011 /Side effects and trials
Hospital doctors report more side effects than presumed
In April, the Danish Medicines Agency published the results of its nationwide campaign "React when serious and unexpected side effects occur" targeting Danish hospital doctors. The results showed that hospital doctors had put more focus on identifying and reporting side effects, and that the number of reports submitted by hospitals across Denmark had increased by 8 % from 2009-2010. It now turns out that the results are even better, and that the hospital doctors have put even greater efforts into correcting the underreporting which characterises the pharmacovigilance area.
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16 May 2011 /Side effects and trials
Increased risk of new blood clots due to pain-relieving medicine
Persons who have previously had a blood clot in the heart have a significantly increased risk of getting another blood clot if they take pain-relieving medicine of the NSAID type such as Ipren® and Voltaren®.
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10 May 2011 /Side effects and trials
The Danish Medicines Agency prefers clinical trial applications on CD-ROM or sent via Eudralink
In future, the Danish Medicines Agency will prefer to receive clinical trial applications on CD-ROM or online via Eudralink. This is because we have migrated to digital processing and consequently scan all incoming post, which is then distributed electronically internally.
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18 April 2011 /Side effects and trials
Bisphosphonates may cause atypical fractures
Treatment with bisphosphonates may cause atypical fractures of the femur – especially in patients who have received long-term treatment for osteoporosis; concludes the European Medicines Agency, EMA, on the basis of a review it recently completed.
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11 April 2011 | Updated 18 April 2011 /Side effects and trials
Report side effects from medicines, herbal medicines and food supplements
At the Danish Medicines Agency, we receive reports of side effects from doctors, medicine users and relatives. You can report side effects from any type of medicines and herbal medicines, and it is of no importance whether you bought the product over the counter or on prescription.
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15 April 2011 /Side effects and trials
EMA recommends interim changes to the summary of product characteristics of Pandemrix®
The European Medicines Agency, EMA, recommends that the product information for the influenza vaccine Pandemrix® should be amended to advise prescribers to weigh the benefits against the risks when considering the medicine for a child or adolescent.
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05 April 2011 | Updated 14 April 2011 /Side effects and trials
Danish hospitals are stepping up side effect reporting
As a result of the Danish Medicines Agency’s campaign “React when serious and unexpected side effects occur”, hospital doctors have more than ever contributed with information and thus given us a better basis to regularly assess the safety of the medicine on the market: Hospital doctors have put more focus on identifying and reporting side effects, and the number of reports submitted by hospitals across Denmark has increased on average.
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12 April 2011 /Side effects and trials
Implementation of MedDRA version 14.0
MedDRA is updated every six months, and on 1 March 2011, MedDRA version 14.0 was released. Therefore, MedDRA version 14.0 will be implemented the night before Monday 2 May 2011.
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05 April 2011 /Side effects and trials
Cases of narcolepsy in adolescents after vaccination with Pandemrix® in France
The French medicines agency (Afssaps) has announced that they have received more reports of the sleep disorder narcolepsy than expected, among adolescents aged 10 to 15 who have received the influenza vaccine Pandemrix®. The French health authorities consider it to be a slight signal of possible problems with Pandemrix®, which is still watched closely.
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01 April 2011 /Side effects and trials
Companies' (MAH) handling of adverse reaction reports received via E2B from the Danish Medicines Agency
When the Danish Medicines Agency sends adverse reaction reports via E2B to marketing authorisation holders (MAHs), it sometimes happens that an MAH returns the adverse reaction report to Danish Medicines Agency via E2B.
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01 April 2011 /Side effects and trials
Public access to EU clinical trials register
The register will, in time, cover all clinical trials in the EU, Iceland, Norway and Liechtenstein. The register provides knowledge about purpose and content of the thousands of ongoing or completed trials in Europe.
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28 March 2011 | Updated 01 April 2011 /Side effects and trials
Reports of blood clots from the use of Vivaglobin®
The Danish Medicines Agency has been made aware of a few post-marketing reports of severe cases of blood clots associated with the use of Vivaglobin® manufactured by CSL Behring. None of the reports are from Denmark.
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29 March 2011 /Side effects and trials
Acknowledgement Message (ACK) for receipt of an adverse reaction report
The Danish Medicines Agency's new pharmacovigilance system now dispatches ACKs in batch runs. That is why you will no longer receive an ACK immediately after you have submitted an adverse reaction report to the Danish Medicines Agency.
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29 March 2011 /Side effects and trials
Swedish study increases suspicion about link between Pandemrix® (the pandemic vaccine) and the sleep disorder narcolepsy in children and adolescents
A recently completed Swedish registry study indicates that children and adolescents under the age of 20 have a four times higher risk of developing the sleep disorder narcolepsy if they have received the influenza vaccine Pandemrix® compared to those who are not vaccinated. The results from this study are in line with the results of a similar Finnish study.
