PARIS: A European Medicines Agency (EMA) said yesterday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins — when correctly prescribed. The clot risk was “low,” said EMA ruling on a French-initiated review of the drug’s safety.
But it stressed Diane-35 and its generics should be used only for acne treatment, as indicated by the pill’s German manufacturer, Bayer.
It should only be prescribed when alternative acne treatments had failed, and measures must be taken to minimize the blood clot risk.
“These medicines should be used solely in the treatment of moderate to severe acne... in women of reproductive age,” the agency said in a statement.
“Since Diane-35 and its generics are hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives” — this would expose them to high doses of the female hormone estrogen, which has been linked to thrombosis.
Diane-35 is authorized in over 100 countries and used by millions of women. According to the package insert on Bayer’s website, Diane-35 is indicated for hormonal skin conditions in cases that other treatments had not worked.
The leaflet seeks to discourage the drug’s use for birth control alone — although Diane-35’s hormone make-up means it acts as a contraceptive by blocking ovulation.
The insert does warn of a higher risk of blood clots in the blood vessels, which can break off and obstruct blood flow to key organs and cause heart attacks or strokes, even death.
In January, French health regulator ANSM suspended sales of the hormone tablet which it linked to four thrombosis deaths and more than 100 cases of blood clots in the past 25 years.
In France, Diane-35 is authorized for acne treatment but is sometimes prescribed as a contraceptive — about 315,000 women in the country used it in 2012.
In some European countries it is authorized for use as a dual acne treatment-contraception solution.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) made its ruling on Diane-35 in a sitting this week.
“Based on all available data, the PRAC concluded that Diane-35 and its generics have a place as a treatment option for certain women suffering form the above-mentioned (skin) conditions,” said the statement.
But it “acknowledged that there is a need to take further measures to better address and minimize the risks of thromboembolism associated with these medicines.”
The committee recommended that new warnings be developed, and said patients must be made aware of the risks, signs and symptoms of blood clots.
Diane-35 acne pills help outweigh blood clot risk: EMA
Diane-35 acne pills help outweigh blood clot risk: EMA
Where We Are Going Today: Auria
- The restaurant itself is very spacious, offering seating on both sides of the dining area
Situated on the bustling Takhassusi Road, Auria offers a high-end dining and bakery experience in the heart of the capital.
The best way to describe the restaurant is modern and cozy, featuring dim lighting, comfortable seating, and attentive staff.
Before diving into the menu and recommendations, it is worth noting the restaurant’s no-children policy — a choice that feels somewhat unusual given that Riyadh is such a family-oriented city.
Those arriving with children under the age of 13, whether with a reservation or as a walk-in, can expect to be turned away and denied service.
The restaurant offers a fine-dining experience characterized by smaller, more refined portions at a higher price point.
Most starters range from SR55 ($15) to SR75, while the majority of main dishes fall between SR85 and SR135.
Among the starters, the highly recommended dishes include the crispy shrimp tempura — four pieces served with a zesty chili-yuzu mayo — and the lobster kari, which features prawns, cream cheese, and a vibrant coriander-jalapeno dressing.
Another top-rated starter is the grilled corn salad, a vibrant mix of avocado, citrus, and fresh herbs topped with caramelized nuts. The shrimp salad also makes for a refreshing beginning, though it remains a third-choice contender when compared to the standout corn salad.
Regarding the pasta, both the penne arrabbiata and the rigatoni pecorino felt somewhat standard. While well-executed, they were not quite as exciting as the rest of the menu.
For the main courses, there is a choice of several proteins, including sea bass, lamb, veal, chicken and steak. Of these, the most highly recommended are the grilled prime angus fillet and the veal al limone.
The steak was exceptionally tender and juicy, yielding easily to the knife, while the veal was light and buttery with a bright citrus finish.
We were warmly greeted with traditional Saudi coffee, and throughout our meal, our coffee cup was never allowed to run dry.
The restaurant itself is very spacious, offering seating on both sides of the dining area.
While the oversized, cozy chairs are a key attribute of the luxurious ambiance, they are quite heavy and difficult to adjust, often requiring the assistance of a server to help you slide in or out of the table.
In addition to the lunch and dinner service, the restaurant offers a breakfast menu which we have not tried yet.
While the no-children policy and the premium price point may be factors, the quality of the food and the quiet, upscale atmosphere make it a notable, under-the-radar destination in Riyadh.
