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13 December 2010 /Side effects and trials
Exercise particular caution when using Extraneal Viaflex® and Nutrineal Viaflex® peritoneal dialysis solution
A number of units of Baxter’s peritoneal dialysis solution of the brands Extraneal® and Nutrineal® manufactured in Ireland are suspected of containing a too high content of endotoxin. A too high content of endotoxin may pose a risk of aseptic peritonitis (infection of abdominal fluid).
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10 December 2010 /Side effects and trials
Update of validation rules for electronic reporting of adverse reactions
We are updating the validation rules in connection with the implementation of the Danish Medicines Agency's new adverse reaction database. The changes, which entered into force on 6 December 2010, are.
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29 November 2010 /Side effects and trials
Delay in acknowledgements for adverse reactions submitted from 1 December to 6 December 2010
Companies submitting electronic adverse reaction reports to the Danish Medicines Agency in the period from 1 Dece´mber up to and including 6 December are advised that the electronic acknowledgement will be delayed.
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10 November 2010 /Side effects and trials
Pregnancy and use of over-the-counter painkillers
A new Danish study has shown that the use of paracetamol during pregnancy may be associated with an increased risk of cryptorchidism in baby boys at birth1. Cryptorchidism is a condition where the testicles have not descended into the scrotum at birth.
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29 October 2010 /Side effects and trials
Assessment of safety of methylphenidate in ADHD treatment
The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.
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29 October 2010 /Side effects and trials
Implementation of MedDRA version 13.1
MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by ICH (International Conference on Harmonisation).
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25 October 2010 /Side effects and trials
Adjustment of new validation rules for electronic exchange of adverse reaction data
On 11 October, the Danish Medicines Agency, implemented the updated validation rules for electronic exchange of E2B files ((ICH E2B (R2)) EV7 Release 1.
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06 October 2010 /Side effects and trials
Implementation of new validation rules for electronic exchange of adverse reaction data
Companies which report adverse reaction data to the Danish Medicines Agency are advised that on Monday 11 October 2010, we will be implementing the updated (ICH E2B (R2)) validation rules for the exchange of E2B files, which entered into force on 1 June 2010.
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24 September 2010 /Side effects and trials
EMA recommends suspension of rosiglitazone-containing medicines (Avandia®, Avandamet® and Avaglim®)
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has reviewed the benefits and risks of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim) used in diabetes care.
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22 September 2010 /Side effects and trials
Octagam® recalled by the Danish Medicines Agency
Based on increased reports of blood clots from the use of Octagam® 50 mg/ml in 2010, the Danish Medicines Agency has decided to recall Octagam® in Denmark. Octagam® is available in two strengths (50 mg/ml and 100 mg/ml) both of which are recalled.
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15 September 2010 /Side effects and trials
React to serious and unexpected side effects
In week 37 the Danish Medicines Agency launches a nationwide campaign, setting out to encourage hospital doctors to be more active in reporting serious and unexpected side effects from medicine. The Danish Medicines Agency runs this campaign because it estimates that whenever one side effect is reported by a hospital doctor another 50 serious or unexpected side effects go unreported.
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26 August 2010 /Side effects and trials
Evaluation of possible link between Pandemrix® and narcolepsy
The Medical Products Agency in Sweden is evaluating a possible link between the H1N1 vaccine, Pandemrix®, and the neurological disorder narcolepsy.
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06 July 2010 /Side effects and trials
New validation rules for electronic exchange of adverse reaction data via E2B from 15 September 2010
Companies that report adverse reaction data to the Danish Medicines Agency are advised that new validation rules for electronic exchange of E2B files soon enter into force.
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05 July 2010 /Side effects and trials
Side effects from Eltroxin® - status July 2010
In 2009, the Danish Medicines Agency recorded a rise in the number of reported side effects (adverse reactions) from Eltroxin® after the manufacturer changed the excipients contained in Eltroxin®.
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01 June 2010 /Side effects and trials
Campaign at Danish pharmacies: ”Help us make medicine better for all”
”Help us make medicine better for all” is the message of a new campaign from the Danish Medicines Agency. Via Danish pharmacies, it focuses on how medicine users can report side effects from their medicine.
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10 May 2010 /Side effects and trials
Side effects from Pandemrix® from 23 January to 18 April 2010
In the period from 23 January to 18 April 2010, the Danish Medicines Agency received 35 new side effect reports covering a total of 97 suspected side effects (adverse reactions).
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04 May 2010 /Side effects and trials
Upgrade of the Danish Medicines Agency’s system for electronic transmission of adverse reaction reports via Eudravigilance gateway
On 5 May 2010, the Danish Medicines Agency will perform an upgrade of the system for transmission of adverse reaction reports between the European Medicines Agency and the pharmaceutical companies (Cyklone to Axway version 5.2.2)
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22 March 2010 /Side effects and trials
EMA updates warning on clopidogrel-containing medicines
In May 2009, the European Medicines Agency (EMA) raised concern about a possible risk of interaction between proton pump inhibitors (PPI) and clopidogrel-containing medicines.
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25 February 2010 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 September – 31 December 2009
In the period from 1 September to 31 December 2009, the Danish Medicines Agency received 22 adverse reaction reports with a total of 52 suspected side effects from Gardasil®.
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29 January 2010 /Side effects and trials
Side effects from Pandemrix® from 9 to 22 January 2010
In the period from 9 to 22 January 2010, the Danish Medicines Agency received 28 new side effect reports covering a total of 63 suspected side effects (adverse reactions).
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22 January 2010 /Side effects and trials
European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events
Sibutramine is a medicine used to promote weight loss, which has been marketed in Denmark since 2001 under the name Reductil®.
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15 January 2010 /Side effects and trials
Side effects from Pandemrix® from 19 December 2009 to 8 January 2010
In the period from 19 December 2009 to 8 January 2010, the Danish Medicines Agency received 32 new side effect reports covering a total of 73 suspected side effects (adverse reactions).
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08 January 2010 /Side effects and trials
Minutes of the Pharmacovigilance Working Party's meeting held on 21-23 September.
The Pharmacovigilance Working Party (PhVWP) under EMEA's Committee for Medicinal Products for Human Use (CHMP) held its September 2009 plenary meeting on 21-23 September 2009.
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07 January 2010 /Side effects and trials
Side effects from Eltroxin® - status January 2010
The Danish Medicines Agency has recorded an increase in the number of reported side effects from Eltroxin®. The increase is observed after the manufacturer changed the excipients contained in Eltroxin®.
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04 January 2010 /Side effects and trials
Side effects from Pandemrix® from 12 to 18 December 2009
In the period from 12 to 18 December, the Danish Medicines Agency received 48 new side effect reports covering a total of 121 suspected side effects (adverse reactions).
