The new patient Medication Guide for prescription antidepressants is expected to be in pharmacies beginning the week of March 7.

The standardized MedGuides are being issued as tear-off pads; pharmacists will provide patients with one of the MedGuide sheets with each antidepressant prescription.

Manufacturers are using a third-party contractor to ship the MedGuide to pharmacies and physicians.

FDA expects the MedGuides will be available in the form of tear-off pads for about a year.

The agency said it has officially requested that antidepressant manufacturers convert to unit-of-use packaging that will allow the ¹ MedGuide to be pre-packaged with every prescription.

The agency had originally hoped to have the MedGuides available by the end of January (² 'The Pink Sheet' Nov. 8, 2004, In Brief).

The creation of a consumer medication guide was recommended by an FDA advisory committee and requested by the agency in October 2004 letters to manufacturers. FDA also requested the addition of a "black box" warning and other language on pediatric suicidality to antidepressant labeling (³ Also see "Antidepressant “Black Box” Presents Barrier To DTC Advertising" - Pink Sheet, 18 October, 2004., p. 3).

FDA made changes to the proposed class labeling after manufacturers responded to the October request. Revisions included softening statements on the connection between suicidal behavior and use of the drugs (⁴ [A#00670080005], p. 9).

On Jan. 12, the agency issued approval letters to companies that had agreed to FDA's class labeling and "approvable" letters to those companies whose own proposed labeling differed substantially from FDA's proposal, the agency said.

GlaxoSmithKline's Paxil (paroxetine) and Wellbutrin/Zyban (bupropion) and Organon's Remeron (mirtazapine) were among the Jan. 12 approvals (⁵ [A#00670030001], p. 3).

Additional minor revisions to the standard labeling and MedGuide prompted a new round of letters to all manufacturers on Jan. 26 to "clarify the requested revisions," FDA said.

The Jan. 26 letter reset the clock for implementing previously approved labeling changes: those companies that had received an approval letter Jan. 12 had two weeks from Jan. 26 to make changes to online labeling and 30 days to revise printed labeling.

Companies that received approvable letters on Jan. 12 did not receive final approval of the changes until Feb. 18; they have 30 days from that date to update printed labeling.

Batches already in production at the time of the labeling change did not have to be updated.

Although some companies did not receive an official approval letter for the labeling changes until Feb. 18, all of the brand companies had updated the online version of their products' package inserts prior to that date.

According to FDA, the recipients of the ⁶ Feb. 18 approval letter were Forest ( Celexa and Lexapro ), Lilly ( Cymbalta , Prozac and Symbyax ), Wyeth ( Effexor ), and Pfizer ( Zoloft ).

All innovator products have now received final approval for changes to their labeling, FDA said.

The Feb. 18 letter did not address marketing of the drugs, so the latest date given for bringing direct-to-consumer advertising into compliance (30 days after Jan. 26) has already passed. Products with "black box" warnings may not use reminder ads.

On the generics side, the Office of Generic Drugs has requested labeling changes from manufacturers that market compounds for which there is no longer a brand product available.

Generic manufacturers of Asendin (amoxapine), Elavil (amitriptyline), Etrafon/Triavil (perphenazine/ amitriptyline), fluvoxamine, Ludiomil (maprotiline), Tofranil (imipramine) and Vivactil (protriptyline) will submit the labeling changes as a "changes being effected" supplement, OGD said.

Manufacturers of generic versions of branded products that are still on the market will update labeling to match the innovator product language.

Antidepressant MedGuide Distribution Imminent; Unit-Of-Use Packs To Follow

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