The original article can be found in: BVI News Online By Government Information Service – Thursday, April 11th
Women in the Virgin Islands who have experienced an adverse reaction 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.
Speaking exclusively with the Department of Information and Public Relations, Chief of Drugs and Pharmaceutical Services, Ms. Gracia Wheatley stated, “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 the 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 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.
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 468.9850. Alternatively persons may email grwheatley@gov.vg.
The Ministry of Health and Social Development endeavors to provide leadership which promotes health, social well-being and a safe environment.
