News

Nyt Om Bivirkninger 25 april 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Danish Pharmacovigilance Update, 17 January 2013

In this issue of Danish Pharmacovigilance Update: The Pharmacovigilance Risk Assessment Committee, PRAC, finds that the risks outweigh the benefits from the use of Tredaptive®

Danish Pharmacovigilance Update, 15 November 2012

In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.

Danish Pharmacovigilance Update, 20 September 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.

Warning against illegal potency enhancers

The Danish Health and Medicines Authority warns against widespread sale of illegal potency enhancers. Over the first nine months of 2012, the Danish Health and Medicines Authority was made aware of 54 illegal potency-enhancing products found to contain active pharmaceutical ingredients not declared anywhere on the package or in the product information. The findings are a result of international cooperation.

Danish Pharmacovigilance Update, 16 August 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.

Danish Pharmacovigilance Update, 24 May 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website.

Danish Pharmacovigilance Update, 15 March 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy.

Changed opening hours on 29 February and 1 March

In connection with the merger with the Danish National Board of Health, the Danish Medicines Agency will be closed on 29 February until 12:00 noon.On Thursday 1 March, the reception and main entrance at Axel Heides Gade will be closed until 11:30.

Danish Pharmacovigilance Update, 19 January 2012

In this issue of Danish Pharmacovigilance Update read about the risk that patients treated with statins develop diabetes, and proton-pump inhibitors (PPI) and the risk of hypomagnesaemia with long-term use.

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Pharmacovigilance Update, 15 September 2011

In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.

Indication, 30 June 2011

In the June issue, catch up on the amendments to the Danish Medicines Act and more.

Report on the blood product area in 2010

In 2010, 337,000 blood collections were made in Denmark. This is approximately 21,000 collections less than the previous year.

Urine-derived fertility medicines are still safe

The Danish Medicines Agency has been made aware of a recent discussion on Facebook about detection of prions (naturally occurring proteins) in urine-derived fertility medicines and a discussion of the medicine's safety. The Danish Medicines Agency advises that the prions in urine-derived fertility medicines that we referred to in our announcement on 2 May 2011 have not been associated to diseases - including the brain disease Creutzfeldt-Jakob disease.

Danish Pharmacovigilance Update, May 2011

Among the articles in this issue of Danish Pharmacovigilance Update is a status on adverse reaction reports for contraceptive pills.

Detection of prion protein in urine-derived hormonal preparations does not give rise to discourage use

A recent article from a French/American/Canadian team of researchers explains detection of prion protein in a number of urine-derived hormonal preparations for the treatment of female infertility.

Indication, march 2011

In this issue of Indication you can read about The Danish Medicines Agency's new strategy, how companies and scientists can save resources by applying for approval of a clinical trial through the European Voluntary Harmonisation Procedure, the daily work of evaluating serious side effects, and whether the differences between men and women should be reflected in the development of new medicines.

Danish Pharmacovigilance Update, 17 March 2011

This month’s issue of Danish Pharmacovigilance Update includes articles about reports of serious side effects in Japan from the childhood vaccines Prevenar (PCV7)® and Act-Hib® and reports of serious side effects in France from the childhood vaccine Prevenar13®.

Age limit of 18 years introduced for buying painkillers

As of 7 March 2011, young people under the age of 18 will only be allowed to buy painkillers at a pharmacy, and only on prescription from a doctor.

Avoid dangerous weight-loss products

The Danish Medicines Agency once again puts focus on the risk of weight-loss products containing the active substances ephedrine, rimonabant and sibutramine - weight-loss products that have not been authorised by the authorities.

Moderate catch in fitness centres

The Danish Veterinary and Food Administration and the Danish Medicines Agency only found a small number of violations of the Danish Food Act and the Danish Medicines Act during a joint on-site inspection of some 30 fitness centres and clubs in autumn 2010.

Expiry of transitional arrangement for traditional herbal medicinal products and natural medicinal products

Since 2005, it has been possible in Denmark to have traditional herbal medicinal products registered as an alternative way of bringing herbal medicines onto the Danish market.

Danish authorities assess risk of calcium supplements

Do calcium supplements increase the risk of blood clots? Are changes to the official recommendations required? These questions are now being discussed by the Danish Veterinary and Food Administration and the Danish Medicines Agency, etc. after an article in the British Medical Journal (BMJ) suspected calcium supplements of increasing the risk of heart attacks.

Danish Medicines Agency co-organises biosimulation workshop on 11 March 2010

The Danish Medicines Agency co-organises a workshop on biosimulation taking place on Thursdag 11 March 2010 in the city of Lund in Sweden.

Vacancy for an Executive Director of the European Medicines Agency

The European Medicines Agency (EMA) is looking for an Executive Director to lead and manage the Agency and take overall responsibility for its operations, thus ensuring achievement of the Agency's objectives.

The Danish Medicines Agency and the Danish Veterinary and Food Administration complete joint control of five sports stores

The Danish Medicines Agency and the Danish Veterinary and Food Administration complete joint control og five sports stores.

Medicines and weight loss

A number of medicines are available on the market for the treatment of life-threatening obesity. Most of these products are sold on prescription, but just recently a new medicine called Alli® was launched for over-the-counter sale.

Unchanged recommendations for menopausal hormone replacement therapy

On 14 January, the results of two scientific studies were published in the US journal Neurology. The studies examined the effect of so-called conjugated oestrogens on the brain in women above the age of 65.

Medicine trials – fiction and reality

The Danish movie "Den Du Frygter" (The One You Fear), which premiered on 19 December, focuses on trials of medicine. The main character in the film participates in a trial that is cancelled due to dangerous side effects.

Illegal distribution of electronic cigarettes

Recently, the Danish Medicines Agency has been made aware that a number of electronic cigarettes, and similar products, are being sold illegally, e.g. via the internet. The products are sold under various product names.

Illegal anti-impotence drug sold via coupon leaflets

The Danish Medicines Agency has become aware that the product Orexi+ from the Norwegian company Medisinsk Forlas AS is sold illegally via Danish coupon leaflets.

Heavy metals in products for traditional Indian healing

Health Canada, the Canadian pharmaceutical authority, has issued a warning about prodcuts used for traditional Indian healing containing large amounts of heavy metals, such as lead, mercury and/or arsenic.