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There are no accurate means of determining whether an exposed fetus has been affected.

Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. Under this program, prescribers must be registered and activated with the i PLEDGE Program and can prescribe isotretinoin only to registered patients who meet all the requirements of i PLEDGE.

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and a Chief Executive Officer & Director at Mylan Pharmaceuticals, Inc. Bresch was previously employed as a Head-North American Operations by Mylan Laboratories, Inc., a Head-North American Operations by Mylan Institutional, Inc., a Chief Integration Officer by Mylan Laboratories Ltd., and a Head-North American Operations by Mylan Technologies, Inc.

Bresch is a Chairman at Association for Accessible Medicines, a Chief Executive Officer & Executive Director at Mylan NV, a Chief Executive Officer & Director at Mylan, Inc.

No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin.

Isotretinoin use has been associated with pseudotumor cerebri, a condition caused by increased pressure on the brain.

There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period of time.

Potentially any fetus exposed during pregnancy can be affected.

This condition may occur more often in patients also taking tetracycline.

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