News | Danish Health and Medicines Authority

18 May 2013 /Side effects and trials

The benefits of acne treatment (Diane® Mite, etc.) still outweigh risks in specific patients

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has investigated the safety of medicines containing cyproterone acetate and ethinylestradiol, which are used in the treatment of acne (Diane® Mite, etc.). The Committee concludes that the benefits of this type of medicine outweigh the risks, provided it is used in specific patients and measures are taken to minimise the risk of blood clots.

03 May 2013 /Side effects and trials

New version of the guidance document Voluntary Harmonisation Procedure for clinical trials

April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

30 April 2013 /Side effects and trials

New European list of medicines under additional monitoring

The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.

29 April 2013 /Side effects and trials

Adverse reactions from non-interventional studies to be reported as 'report from study'

The Danish Health and Medicines Authority advises that adverse reactions from non-interventional studies published in the scientific literature should be reported as 'reports from study'. Also, they should only be reported to us if either the authors of the literature article or the marketing authorisation holder (or both) asses that there is a causal relationship between the drug and the adverse drug reaction.

11 February 2013 /Side effects and trials

Direct Healthcare Professional Communication is published on the website

The Danish Health and Medicines Authority will in future place the Direct Healthcare Professional Communications (DHPCs) that are sent out in Denmark to doctors and others here on the website.

31 January 2013 /Side effects and trials

Doctors in Denmark follow the recommendations for contraceptive pills

The French authorities recently asked the Pharmacovigilance Risk Assessment Committee (PRAC) to review the safety of the newer types of contraceptive pills (3rd and 4th generations). This follows the last couple of years' several investigations which have indicated that these pills carry a small increased risk of blood clots compared to the older versions (2nd generation). In Denmark, we have already taken steps to counter this increased risk

31 January 2013 /Side effects and trials

France removes acne pills (Diane® Mite etc.) from the market

Following a review of effect and risk of blood clots, the French authorities have decided to remove cyproterone/oestrogen-containing medicines from the market within three months.

04 January 2013 /Side effects and trials

Answers to questions about post-authorisation safety studies

We have updated our questions and answers about clinical trials with further details about the so-called post-authorisation safety studies (PASS studies).

16 November 2012 | Updated 16 November 2012 /Side effects and trials

21 December is final date for submission of clinical trial applications in 2012

The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2012 must reach us by 21 December 2012. All applications that we receive after this date will be considered received on 2 January 2013.

05 November 2012 /Side effects and trials

European Medicines Agency has started review of codeine-containing medicines

On 3 October 2012, the European Medicines Agency (EMA) started a review of codeine-containing medicines. Codeine-containing medicines are used for pain relief in adults and children. Codeine is to a limited degree converted into morphine in the body. It is well-known that some patients convert codeine to morphine at a faster rate than others, resulting in higher than normal levels of morphine in their blood. This may cause side effects such as breathing difficulties.

19 October 2012 /Side effects and trials

The Danish Health and Medicines Authority maintains influenza vaccine recommendation

The European Medicines Agency, EMA, has reviewed a hypothesis on Pandemrix® and the development of sleep attacks (narcolepsy). Overall, EMA assesses that there are no grounds for concerns regarding Pandemrix® and other vaccines, including influenza vaccines.

19 October 2012 /Side effects and trials

Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects

In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.

15 October 2012 /Side effects and trials

The Danish Health and Medicines Authority still recommends influenza vaccine

The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.

28 September 2012 /Side effects and trials

Doctors in Denmark follow new recommendations for contraceptive pills

In early 2012, the Danish Health and Medicines Authority recommended doctors to generally prescribe the older type of contraceptive pills (2nd generation pills) because these pills pose the lowest risk of blood clots. In a follow-up report, the Danish Health and Medicines Authority has now reviewed the latest scientific articles as well as the consumption trends and reported side effects for contraceptive pills prescribed in Denmark.

27 July 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – July 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 July 2012.

25 July 2012 /Side effects and trials

Sun, heat and medicine

Various medicines can make your skin more sensitive to sunlight (photosensitivity), and it concerns both medicines in tablet form and other forms, such as creams. You should therefore protect yourself from the sun by wearing clothes, a hat or by using a good sunscreen if you take medicine that makes your skin more sensitive to light.

05 July 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.

03 July 2012 /Side effects and trials

New study on treatment with HES (hydroxyethyl starch) in patients with severe sepsis

A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis. The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period. The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.

19 June 2012 /Side effects and trials

European Medicines Agency assesses risk of the arthritis medicine diclofenac

In response to recent days' debate about the safety of the arthritis medicine diclofenac, the Danish Health and Medicines Authority urges doctors to carefully follow the restrictions and precautions for use that are already described in the medicine's summary of product characteristics and on the Danish website medicin.dk.

14 June 2012 /Side effects and trials

Low oestrogen dose in contraceptive pills reduces risk of blood clots

The risk of forming blood clots in brain and heart from the use of contraceptive pills has become smaller as the dose of oestrogen contained in contraceptive pills has been lowered. Moreover, blood clots in brain and heart are generally less frequent than blood clots in legs and lungs, so shows a new Danish study on a cohort of 1.6 million Danish women aged between 15 and 49.

07 June 2012 /Side effects and trials

Report on clinical trials of medicines in humans notified in 2011

The Danish Health and Medicines Authority has published an annual report on applications for clinical trials of medicines in humans.

31 May 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – May 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 21-23 May 2012.

29 May 2012 /Side effects and trials

Risk of blood clots associated with hormonal contraceptives

A new major Danish registry study has investigated the risk of blood clots in women using different types of hormonal contraceptives. The study concludes, among other things, that women using a vaginal ring (Nuvaring®) or contraceptive patch (Evra®) have the highest risk of blood clots.

24 May 2012 /Side effects and trials

European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials

The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

23 May 2012 /Side effects and trials

Increased risk of cardiac arrest associated with the use of TCA and SSRI antidepressants

A new Danish study has found an increased risk of cardiac arrest associated with treatment with TCAs (tricyclic antidepressants) or SSRIs (selective serotonin reuptake inhibitors). The study found no association between increased risk of cardiac arrest and the use of SNRI antidepressants (serotonin and norepinephrine reuptake inhibitors) or NaSSA antidepressants (noradrenergic and specific serotonergic antidepressants).

15 May 2012 /Side effects and trials

Pradaxa – consider age and follow dose recommendations

In March, in collaboration with the Thrombosis Centre in Aalborg, the Danish Health and Medicines Authority published an evaluation of all adverse reaction reports in Danish Pharmacovigilance Update for the period 22 August 2011 up to and including 23 February 2012 in connection with a new indication (prevention of apoplexy in patients with non-valvular atrial fibrillation) for Pradaxa® (dabigatran etexilate). With this announcement, we once more want to call attention to the development in consumption, reported adverse reactions, age and dose recommendations.

10 May 2012 /Side effects and trials

Drug Analysis Prints with data from more than 14,000 side effect reports

In February, the Danish Health and Medicines Authority published the first 14 of approximately 1,000 adverse reactions prints, called Drug Analysis Prints, of suspected adverse drug reactions (ADRs) reported by doctors, patients and relatives. We have now published the rest.

01 May 2012 /Side effects and trials

Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR

The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.

01 May 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – April 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 April 2012. Among the topics discussed at the meeting were:

01 May 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – March 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 March 2012. Among the topics discussed at the meeting were:

25 April 2012 /Side effects and trials

Use of EU register facilitates publication of clinical research

Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers. They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.

23 April 2012 /Side effects and trials

Gilenya (fingolimod) – new recommendations to reduce risk of adverse effects on the heart

The European Medicines Agency has recommended new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis treatment Gilenya (fingolimod).

13 April 2012 /Side effects and trials

Risk-adapted assessment of clinical trials of already marketed medicinal products

The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation. We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.

15 March 2012 | Updated 16 March 2012 /Side effects and trials

New data on antidepressants of the SSRI type and prevalence of malformations in newborns

Data from a large Danish registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with an antidepressant of the type selective serotonin reuptake inhibitors (SSRIs). The Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.

01 March 2012 /Side effects and trials

EMA has updated its questions and answers about GCP

In certain types of trial designs, the investigator and patient do not know whether the patient receives a placebo drug (inactive substance) or a medicine containing an active substance. But in some situations, the investigator needs to know what the patient has been given, in which case it should be possible for the investigator to break the blinding. The new question from EMA deals with whether or not the investigator is to contact the sponsor before he or she breaks the blinding for a patient in a trial.

28 February 2012 /Side effects and trials

Delay in ACKs for adverse reaction reports due to IT maintenance

EMA is performing maintenance of the EudraVigilance database, including the gateway, from 29 February 2012 to 5 March 2012. There will therefore be a delay in the dispatch of acknowledgement messages (ACKs) for adverse reaction reports.

24 February 2012 /Side effects and trials

The Danish Medicines Agency publishes prints of reported side effects for download

The Danish Medicines Agency has just published its first complete prints of suspected adverse drug reactions from medicines that doctors, patients and others have reported. To begin with, we provide access to the adverse drug reactions reported for 13 selected active substances.

23 February 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – February 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 13-15 February 2012. Among the topics discussed at the meeting were Docetaxel actavis and Good Pharmacovigilance Practices (GVP) for the EU.

20 February 2012 | Updated 21 February 2012 /Side effects and trials

New contraindications and warnings for blood pressure medicines with the substance aliskiren

The European Medicines Agency, EMA, has just finalised a review of the benefits and risks of blood pressure medicines with aliskiren. The review has resulted in new contraindications and warnings for these medicines.

01 February 2012 /Side effects and trials

Adverse reaction reports on antidepressants and pregnancy - October to December 2011

On 20 September 2011, the Danish Medicines Agency published a report (in Danish) on antidepressants of the SSRI type. The report's main focus was on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. This 2nd follow-up covers the period from 10 October 2011 to 31 December 2011.

31 January 2012 /Side effects and trials

Older contraceptive pills still pose the lowest risk of blood clots

The Danish Medicines Agency has reviewed the most important literature on contraceptive pills and the risk of blood clots as well as the most recent data on consumption and reported side effects in Denmark. The Danish Medicines Agency therefore encourages doctors to reduce the known risk factors for blood clots by prescribing 2nd generation contraceptive pills as the first choice to the extent possible.

31 January 2012 /Side effects and trials

New report on long-term treatment of osteoporosis patients with bisphosphonates

In a new report "Long-term treatment of osteoporosis patients with bisphosphonates", the Danish Medicines Agency reviews treatment patterns and evidence of suspected adverse reactions of long-term treatment with bisphosphonates.

11 January 2012 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – December 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 December 2011. Please find an extract of some of the topics discussed.

04 January 2012 /Side effects and trials

The prescription-only stop smoking products Zyban® and Champix® and reports of possible side effects

In Denmark, you can get smoking cessation medicine both over the counter and on prescription. In total, the Danish Medicines Agency has received reports on possible side effects from 480 persons who used Zyban® or Champix® in the period 2001-2011. Eight of these reports concern deaths. The Danish Medicines Agency assesses that it is highly unlikely or improbable that any of the eight deaths are due to the medicine.

23 December 2011 /Side effects and trials

EMA to review benefits and risks of blood pressure medicines containing aliskiren

Yesterday, the European Medicines Agency (EMA) started reviewing the benefits and risks of blood pressure medicines that contain aliskiren. Based on the present knowledge, the Danish Medicines Agency does not find that there is cause to review the patients’ treatment urgently.

21 December 2011 /Side effects and trials

EMA confirms a positive benefit-risk balance of medicines containing growth hormone (somatropin)

After completing a review of all available data on medicines containing growth hormone (somatropin), the European Medicines Agency (EMA) confirms that the benefits of these medicines still outweigh their risks.

07 December 2011 /Side effects and trials

Improved guidance on the definition of a clinical trial of medicinal products

The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products. We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial. Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.

25 November 2011 /Side effects and trials

Atomoxetine (Strattera®) and risk of increased blood pressure and heart rate

In November 2011, the European Pharmacovigilance Working Party (PhVWP) concluded that new knowledge should be communicated about the known risk of increased blood pressure and heart rate associated with the use of atomoxetine, which is authorised for the treatment of ADHD (Attention-Deficit/Hyperactivity Disorder).

25 November 2011 /Side effects and trials

Tibolone and potential risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer

The European Pharmacovigilance Working Party (PhVWP) has looked at new data from various epidemiological studies on the connection between the use of tibolone, which is authorised for the treatment of symptoms of oestrogen deficiency due to menopause and for the prevention of osteoporosis, and the risk of thromboembolism, myocardial infarction, breast cancer and ovarian cancer.

25 November 2011 /Side effects and trials

Strengthened suspicion about risk of foetal malformations from use of the antiepileptic topiramate (Topimax® etc.)

It is well-known that use of antiepileptics during pregnancy can cause malformations in the foetus. A recent review of data from two birth registers has reinforced the suspicion concerning the antiepileptic topiramate. The review showed that use of topiramate during the first trimester of pregnancy may cause increased risk of cleft lip and palate, hypospadias and malformations in other parts of the body.

25 November 2011 | Updated 25 November 2011 /Side effects and trials

New recommendations for escitalopram announced by EMA

In October 2011, the European Pharmacovigilance Working Party, PhVWP, decided that the summaries of product characteristics and package leaflets of medicine containing the antidepressant citalopram must be updated with information on a lower maximum dose. EMA has also reviewed the antidepressant escitalopram and has concluded that the maximum dose of escitalopram should also be reduced.

18 November 2011 /Side effects and trials

Pradaxa (dabigatran etexilate) – remember to assess renal function

At a meeting held 17-20 October 2011, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), strengthened the instructions for doctors' use of dabigatran etexilate with particular focus on patients with impaired renal function.

01 November 2011 | Updated 09 November 2011 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 17-19 October 2011. On the meeting's agenda was antiepileptics, citalopram and domperidone.

02 November 2011 /Side effects and trials

Electronic reporting of SUSARs from other EU countries now possible

The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.

28 October 2011 /Side effects and trials

European Medicines Agency recommends lower dose of citalopram

In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses.

25 October 2011 /Side effects and trials

Number of suspected adverse reactions reported to the Danish Medicines Agency for articaine

In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. We have followed the development since then, and we have decided to review the safety again.

24 October 2011 /Side effects and trials

Adverse reaction reports on antidepressants and pregnancy – June to October 2011

On 20 September 2011, the Danish Medicines Agency published an overview report (in Danish) on antidepressants of the SSRI type, the main focus being on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. In the subsequent period from 14 June 2011 to 9 October 2011, the Danish Medicines Agency has received 12 reports concerning 21 suspected adverse reactions in children/foetuses whose mothers had taken an SSRI.

12 October 2011 /Side effects and trials

Focus on medicines most frequently involved in serious adverse drug events can improve patient safety

A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.

04 October 2011 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – September 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 19-21 September. On the meeting's agenda was: active substances with a known risk of Stevens-Johnson syndrome and toxic epidermal necrolysis.

04 October 2011 /Side effects and trials

Monthly reports from the EU Pharmacovigilance Working Party, PhVWP – June and July 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 20-22 June and 18- 20 July 2011.

27 September 2011 /Side effects and trials

Danish report on treatment with SSRI antidepressants

Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.

23 September 2011 /Side effects and trials

The European Medicines Agency recommends restricted use of Multaq®

The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia. This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.

13 September 2011 /Side effects and trials

Citalopram and the risk of cardiac arrhythmia

The U.S. Food and Drug Administration (FDA) recently issued a warning against using large doses of the antidepressant citalopram. The FDA has reviewed data which shows that doses of citalopram of 60 mg a day may be linked with changes in the heart rate (QT interval prolongation).

08 September 2011 /Side effects and trials

New English e-form for reporting of adverse reactions in clinical trials (SUSARs)

The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance.

23 August 2011 /Side effects and trials

Commission guidance on adverse reactions from clinical trials (CT3) has been changed

The EU Commission has updated its guidance on adverse reactions arising from clinical trials, known as CT3. In future, CT3 will also include the previous Eudravigilance guidance - clinical trial module (CT4) - as well as the Q&A document regarding adverse reaction reports in clinical trials.

11 August 2011 /Side effects and trials

Danish Drug Interaction Database expanded significantly

The Danish website interaktionsdatabasen.dk, where you can find information about interactions between various medicines, has been improved significantly. The Drug Interaction Database is in Danish only. Among the improvements is a general overview of how two different categories of medicinal product groups interact (class effect), the hospital pharmacies' SAD products have been included, and finally, you can search on both active substance and product names for herbal remedies as well as vitamins.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

24 June 2011 /Side effects and trials

Amendments to the guideline on clinical trials in humans

In the Danish Medicines Agency's Clinical Trials department we have reviewed approx. 30 research-initiated applications for authorisation to conduct medicinal product trials submitted in 2010. The review was conducted to assess the need for improved guidance.

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®).

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.

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.

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.

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.

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).

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.

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.

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.

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.

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®.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.