FDA ANNOUNCES ACCUTANE RESTRICTIONS

Everyone who uses the acne drug Accutane will have to enroll in a national registry, along with every doctor who prescribes it and every drugstore that sells it — tough new restrictions aimed at preventing women from becoming pregnant with this birth defect-causing drug.

The Food and Drug Administration announced the long-anticipated program Friday, more than a year after the agency’s scientific advisers urged the extra curbs because repeated safety warnings have failed to stop Accutane-damaged pregnancies.

Both male and female patients will have to enroll in the registry, called iPLEDGE, by Dec. 31 or they can no longer receive Accutane.

All patients also must sign a document informing them of Accutane’s risks, including the possibility that it contributes to depression or suicidal thoughts — a warning that FDA also strengthened on Friday.

But birth defects are the biggest concern with Accutane and its generic version, isotretinoin, medicine that is supposed to be prescribed only for severe acne but that critics say too frequently is given for more minor cases.

The registry actually opens on Aug. 22, giving time for doctors, patients and pharmacies to understand how it will work before the provisions become mandatory. Wholesalers and pharmacies will have to register starting Oct. 31 or the drug’s manufacturers can no longer ship them supplies of the pills.

What is Rosacea Flushing?

Rosacea usually begins with frequent flushing of the face, particularly the nose and cheeks. This facial flushing is caused by the swelling of the blood vessels under the skin. This "red mask" can serve as a flag for attention. Telangiectasis is easy to recognize, characterized by the visible presence of capillaries, bright red in color.

Diffuse redness frequently precedes the appearance of telangiectasis and is a constant flushed appearance. True diffuse redness is quite different from a localized erythema as seen in cases of sunburn, inflammation or over stimulation. With both telangiectasis and diffuse redness, the redness is not transitory and there generally is not an increase in skin temperature, but particularly there are no alterations in the tissue structure or biochemistry as seen in rosacea. The circulatory network of the skin is extensive and the capillaries are the smallest, most delicate vessels.During normal blood circulation the capillaries undergo constant changes. In between beats the pressure is relieved and the vessels constrict back to their normal size. This return to normal size is accomplished by the natural elasticity in the structure of the capillary. If telangiectasis is present, the capillaries' elasticity is deteriorated so they remain slightly dilated.

The constant influx of blood perpetuates this slight dilation. The skin gradually becomes congested and eventually the capillaries become visible through the skin's surface. When it comes to telangiectasis, sometimes a person's lifestyle and habits can be the skin's worst enemy.In a fair, delicate skin predisposed to telangiectasis, a steady diet of hot, spicy food, chronic alcohol consumption and eating meals too quickly will promote telangiectasis. And many retinoids used for acne as well as many harsh soaps continue to aggravate the skin.