[Pflienews] PharmFacts E-News Update: FDA calls for saefty plan for Abortion Drug Mifeprex

[PFLI PharmAid Center]

*PharmFacts E-News Update -- 28 Mar 2008 AD

*http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/8934


  FDA Calls for Safety Plans for 25 Agents

By Michael Smith, North American Correspondent, MedPage Today
Published: March 28, 2008
	Click here to rate this report 
<http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/8934#rate>

ROCKVILLE, Md., March 28 -- The FDA has named 25 drugs and biologic 
products -- including some well-known medications -- whose makers will 
be required to submit safety plans later this year.

The list as published in the /Federal Register/ includes the multiple 
myeloma medication thalidomide (Thalomid), the anti-psychotic clozapine 
(Clozaril), and the abortifacient mifepristone (Mifeprex).

A Risk Evaluation and Mitigation Strategy (REMS) plan must be submitted 
to the agency by Sept. 21 on pain of "enforcement action" including 
monetary penalties, the FDA said.

The move comes under amendments to the Food, Drug and Cosmetic Act, 
passed last year, which gave the FDA authority to require a REMS when a 
drug first comes on the market or when the agency becomes aware of new 
safety data.

The goal is ensure safe use of medications that have risks if used 
improperly, according to Jane Axelrad of the FDA's Center for Drug 
Evaluation and Research.

"These safety plans allow patients to have continued access to certain 
medicines for which there are safety concerns that can be managed 
through appropriate use," Axelrad said.

"The FDA approved the drugs identified today before the new law was 
passed, and they will now be brought under the new statutory authority 
to require and enforce REMS," she added.

Drugs were deemed to need an REMS if:

    * Clinicians who prescribe the drug need particular training or
      experience or are specially certified.
    * Pharmacies, practitioners, or healthcare settings that dispense
      the drug are specially certified.
    * The drug is dispensed to patients only in certain healthcare
      settings, such as hospitals.
    * The drug is dispensed to patients with evidence or other
      documentation of safe use conditions, such as laboratory test
      results.
    * Patients using the drug are subject to certain monitoring.
    * Patients using the drug are enrolled in a registry.

The drugs on the list were all approved before March 25. Drugs approved 
after this date will have the requirement for the REMS imposed at the 
time of approval, the agency said.

The drugs that will need an REMS are:

    * Abarelix (Plenaxis), which is approved but not currently sold in
      the U.S.
    * Alosetron (Lotronex)
    * Ambrisentan (Letairis)
    * Bosentan (Tracleer)
    * Several formulations of Clozapine (Clozaril and Fazaclo ODT)
    * Dofetilide (Tikosyn)
    * Eculizumab (Soliris)
    * Fentanyl PCA (Ionsys), which is approved but not currently not
      sold in the U.S.
    * Fentanyl citrate (Actiq)
    * Several formulations of isotretinoin (Accutane, Amnesteem,
      Claravis, Sotret)
    * Lenalidomide (Revlimid)
    * Mifepristone (Mifeprex)
    * Natalizumab (Tysabri)
    * The live smallpox (vaccinia) vaccine (ACAM2000)
    * Sodium oxybate (Xyrem)
    * Thalidomide (Thalomid)




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