Wwomen in the Virgin Islands who have experienced adverse reaction/s after using the medicine Diane-35® or its generic brands are being asked to make a report to the Office of Chief of Drugs and Pharmaceutical Services in the Ministry of Health and Social Development. Photo: 7DaysinDubai

Chief of Drugs and Pharmaceutical Services, Ms Gracia Wheatley was quoted in a government press release as saying, 'Diane-35® is prescribed for severe acne, oral contraception and hir-su-tism or excessive hairiness on female body parts such as the chin or chest, where hair does not normally occur, or is minimal.' Photo: GIS/File

Chief of Drugs and Pharmaceutical Services, Ms Gracia Wheatley was quoted in a government press release as saying, “Diane-35® is prescribed for severe acne, oral contraception and hir-su-tism or excessive hairiness on female body parts such as the chin or chest, where hair does not normally occur, or is minimal.

The Chief of Drugs and Pharmaceutical Services said, “One common adverse reaction is the formation of blood clots. Symptoms of blood clot formation include persistent leg pain or tenderness, swelling, warmth and redness of the leg, severe chest pain, sudden shortness of breath or difficulty breathing.”

This risk may be increased due to a person’s age, family history of blood clots and lifestyle factors, such as weight and smoking.  Consumers are therefore being encouraged to reduce their risk of developing blood clots by adjusting their lifestyle risk factors as much as possible. 

“A review is now underway as a result of post marketing surveillance over a 25- year period, which recorded an increase in the number of cases of the formation of blood clots in the veins and the arteries,” added Ms Wheatley.

Additionally, the Ministry of Health and Social Development is advising Diane-35® users who develop any symptoms such as sudden shortness of breath or difficulty breathing, to immediately visit their physician or go to the Emergency Room of Peebles Hospital.

The Chief of Drugs and Pharmaceutical Services noted that every Diane-35 user will not experience an adverse drug reaction, but submission of any report is crucial as all the evidence on the benefits and risks of this medicine will be evaluated by the European Medicines Agency Pharmaco-vigilance Risk Assessment Committee.

Following this evaluation they will make recommendations on the status of the medicine and future prescribing practices.

Contacted by Virgin Islands News Online today April 12, 2013 Ms Wheatley said that through her Office it has been confirmed that the drug is stocked and prescribed at pharmacies in the Virgin Islands and because of currents studies that are being done internationally, the advisory was put out.

She said her office has received a number of calls but has cautioned there is no need for panic.

The Ministry of Health and Social Development, through its pharmaco-vigilance programme, is partnering with the French National Agency for Medicines and Health Products Safety, the European Medicines Agency and other countries in reviewing the safety concerns associated with Diane-35®.

Reports can be made to any attending physician or the Office of Chief of Drugs and Pharmaceutical Services at telephone 4689850. Alternatively persons may emailgrwheatley@gov.vg.