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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.
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30 June 2011 /Side effects and trials
Swedish study increases suspicion about link between the pandemic vaccine Pandemrix® and the sleep disorder narcolepsy in children and adolescents
The Swedish Medical Products Agency has published the result of an epidemiological study which increases suspicion about a link between the sleep disorder narcolepsy in children and adolescents and vaccination with Pandemrix® against influenza A(H1N1). There are still no known Danish incidents of narcolepsy in children and adolescents vaccinated with Pandemrix.
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29 June 2011 /Side effects and trials
Problems with dispatching acknowledgement messages (ACKs) for adverse reaction reports from comapanies
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway. Unfortunately, as a result of our problems with the gateway, a considerable number of reports have piled up (backlog). Therefore, there will most likely be delays in dispatching ACKs. We hope to straighten out the situation by the end of the weekend.
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23 June 2011 /Side effects and trials
Need for further review of the risks related to diabetes medicines
Over the past few days, the European Committee for Medicinal Products for Human Use (CHMP) has fast-tracked the results of a new French study. The study shows a small increased risk of bladder cancer in diabetics treated with pioglitazone-containing diabetes medicines. However, the CHMP could not completely confirm an increased risk. Therefore, the Danish Medicines Agency advises Danes to continue their treatment with pioglitazone (contained in the diabetes medicine Actos®).
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23 June 2011 /Side effects and trials
Errors in the dating and the number of adverse reaction reports
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway.
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20 June 2011 /Side effects and trials
Annual report on the Danish Medicines Agency's activities within the pharmacovigilance area in 2010
In 2010, primarily the Danish Minister for the Interior and Health's action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.
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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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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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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.
