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: Makbous Express in Riyadh
- Each option complements the dish in its own way, though the mandi rice seems best suited to absorb the savory depth of the sauce
Sometimes comfort arrives in a takeout box. Makbous Express in Riyadh brings the warmth of home-style cooking to your doorstep, offering familiar Gulf flavors designed for casual indulgence rather than fine dining.
Even without the dine-in experience, the food travels well, retaining much of its authentic charm. The tabolah stands out immediately. A bright mix of parsley, bulgur, tomato, and onion, it tastes crisp and refreshing, cutting through richer dishes with balance and simplicity. It is a welcome palate-cleanser.
The Makbous meat, the restaurant’s bestseller, shows why it carries that title. Tender meat cooked in aromatic saffron sauce arrives perfectly seasoned, with your choice of biryani, mandi, or plain rice.
Each option complements the dish in its own way, though the mandi rice seems best suited to absorb the savory depth of the sauce. This plate captures the essence of Kuwaiti soul food: generous, fragrant, and deeply satisfying.
Less exciting was the shrimp pasta, tossed in Makbous hot sauce. The shrimp were well-cooked, but the overall dish felt predictable, with the sauce adding heat but not much complexity.
The jareesh, made from crushed wheat groats simmered in chicken stock and cumin, then topped with butter or wild ghee, is pure comfort food. Warm, wholesome, and nostalgic, it delivers understated satisfaction rather than surprise. It’s the kind of dish that feels like home cooking done right.
The potato stew was runny for my taste and lacked the richness needed to tie its flavors together. A thicker texture or deeper spice could have made it more enjoyable, especially if it had more body.
Despite a few uneven dishes, Makbous Express succeeds in delivering the homely warmth of Kuwaiti cuisine, one that speaks of tradition, spice, and generosity. It may not dazzle at every turn, but for days when you crave hearty, unpretentious comfort food, this express route hits close to home.
