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FDA Approves Isotretinoin Pregnancy Risk Management Program

Posted on: Friday, 12 August 2005, 12:00 CDT

PRINCETON, N.J., Aug. 12 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has approved iPLEDGE(TM), an enhanced risk management program designed to minimize fetal exposure to isotretinoin, the product's manufacturers announced today. Isotretinoin, which is marketed under the trade names Accutane(R), Amnesteem(R), Claravis(TM) and Sotret(R), is used to treat severe recalcitrant nodular acne that has not responded to other therapies.

The comprehensive iPledge program, to be implemented in stages over the next several months, is designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that no woman starts isotretinoin therapy if she is pregnant and that no woman taking isotretinoin becomes pregnant during treatment. It will replace the existing risk management programs for each product as of December 31, 2005. Isotretinoin has a high risk of birth defects if taken during pregnancy, and an evolving risk management program has been in place since 1988.

The enhanced program was developed cooperatively by the isotretinoin manufacturers along with Covance Inc. , a drug development services company, in collaboration with the FDA.

The manufacturers and distributors of isotretinoin and their products are: Barr Laboratories, Inc. a subsidiary of Barr Pharmaceuticals, Inc. (Claravis(TM)); Genpharm Inc. (a subsidiary of Merck KGaA) and Mylan Pharmaceuticals Inc. (Amnesteem(R)); Ranbaxy Laboratories Inc. (Sotret(R)), and Roche (Accutane(R)).

iPLEDGE will require mandatory registration of prescribers, patients, wholesalers, and pharmacies. The program's requirements - including laboratory-certified monthly pregnancy tests for female patients to confirm pregnancy status before they receive medication each month - will be tracked through the computerized iPLEDGE system. For each isotretinoin prescription each month, iPLEDGE will grant authorization to the pharmacy to dispense the product only if all the criteria for the prescriber, patient, and pharmacy have been met. Part of the system is an interactive component to help ensure that patients understand the requirement of using two forms of effective contraception simultaneously for one month before, during and for one month after isotretinoin treatment. Patient privacy will be protected by identification codes.

Planning and development of iPledge began in early 2004. In January 2005, all current prescribers registered in isotretinoin risk management programs were notified about the upcoming program changes. Prescribers, wholesalers and pharmacies can begin registering with the enhanced program in the next few weeks, and patient enrollment will begin in November.

Once the program is fully implemented in December 2005, Accutane, Amnesteem, Claravis and Sotret can only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Isotretinoin can only be dispensed by a pharmacy registered and activated with iPLEDGE, and can only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.

Additional information regarding registration will be communicated directly to prescribers and pharmacies in the coming weeks. The program's requirements also can be accessed at http://www.ipledgeprogram.com/ or by calling 1-866-495-0654.

SAFETY NOTICE

Isotretinoin must not be used by female patients who are or may become pregnant. 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. 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, as described above.

Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives. Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. 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 a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline. Patients should be aware of other serious side effects, including problems with the pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin.

For full prescribing information, please go to http://www.accutane.com/.

Covance Inc.

CONTACT: Isotretinoin Manufacturer Contacts: Barr Pharmaceuticals, Inc.:Carol A. Cox, Vice President, Investor Relations & Corporate Communications,+1-201-930-3720, ccox@barrlabs.com; Genpharm Inc. (a subsidiary of MerckKGaA): Ian Hilley, Vice President, Business Development & Government Affairs,+1-416-236-2631, ext. 244, ianh@genpharm.ca; Mylan Pharmaceuticals Inc.:Patrick Fitzgerald, Vice President, Public Relations, +1-724-514-1800,patrick.fitzgerald@mylanlabs.com, or Kris King, Investor Relations,+1-724-514-1800, kris.king@mylanlabs.com; Ranbaxy Laboratories Inc.: ChuckCaprariello, VP Corporate Communications and Government Affairs,+1-609-720-5615, chuck.caprariello@ranbaxy.com; Roche: Shelley Rosenstock,Executive Director, Product Public Affairs, +1-973-562-2373,shelley.rosenstock@roche.com, or Gail Safian, Public Affairs, +1-973-562-2193,gail.safian@roche.com; or Laurene Isip, Covance, Inc., +1-609-419-2060,Laurene.Isip@covance.com

Source: PRNewswire-FirstCall

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