Saturday, February 28, 2015

Legacy Schering-Plough Zenhale® Inhalers Recalled -- In Canada Only

Not material to Merck overall -- but noteworthy for its legacy attachment to the Schering-Plough OTC version Nasonex® franchise.

OTC Nasonex (a product and brand now owned by Bayer -- as part of that consumer health transaction) contains some of the same active ingredient as the Zenhale product in Canada. See graphic at right. Here is the relevant Health Canada notice, in any event -- and a bit:

. . . .Merck Canada is initiating a recall of certain lots (see attached list) of Zenhale at the pharmacy/physician level due to the possibility of device malfunction after 24 months shelf-life, resulting in the potential for a patient to receive a lower dose than expected. The company’s investigation has determined that the occurrence of this defect is low.

Merck Canada expects new [inhaler] product to be available in pharmacies by March 23, 2015. Merck Canada will reduce the shelf life of all Zenhale products from 36 months to 24 months. The new product will have a shelf-life of 24 months. . . .

So it goes -- all remedied by March 23, 2015. Thus immaterial. Now, here on a snowy Saturday night -- going to catch up and see Kingsman. . . .UPDATE: it was horrific -- as in an atrocious waste of time.


bearwalk said...

Are you sure that Nasonex went to Bayer
in the consumer products transaction? I really believe it remained with Merck both in the U.S. and ROW. I also miss the connection of Zenhale with Nasonex. Yes, both contain mometasone furoate but that's where similarites end. Zenhale also contains formoterol...much more a second active and is in an aerosol inhaler for asthma whereas Nasonex is in a non-aerosol metered spray for nasal delivery for allergic rhinitis. A better comparison would be with the U.S. Dulera product. Just curious why compare with Nasonex.

Condor said...

Thanks so much bearwalk --

I chose Nasonex over Dulera as the comparator because of legacy Schering Plough's trouble with DTC advertising on that brand.

Search Nasonex FTC in the box on the main page for all the background there.

As to the minor point, this link, which also appears in the main post -- suggests that Bayer has branded the Australian Nasonex page as its own, now that the deal has closed.

Note Bayer's logo in the upper right of the Australian page, in that link. I don't think Kenilworth would allow that -- had the deal not included Nasonex.

In any event, it is certain that Merck has kept Zenhale -- the more potent "behind the counter" version.

I do hear you, and I agree -- on the pharmacology, I might have used Dulera -- but my point was that this is yet another legacy of Fast Fred.

All the best -- and Namaste!

bearwalk said...

Thanks for the clarification. I'm sure you are correct that Nasonex was part of the Bayer deal where Nasonex was already OTC--and they actually have rights to OTC status when it switches. In the U.S. and most markets, Nasonex is still Rx. I'm sorry to be so picky, but you have such a good record and reputation for factual information...just want to help uphold that. To that, it's more than potency: Zenhale is for asthma (orally inhaled) whereas Nasonex is for allergic rhinitis (nasal mist). Sorry to be so OC.

Thanks for what you do!


Condor said...

These are great clarifications.

Do you think I ought to rewrite the item?

I am sure your take is accurate.

At a minimum, I will once again indicate that the Nasonex infor is the OTC version -- my first draft said so, then I deleted that bit.

As ever, I really appreciate your editorial help, John "Bearwalk". . .


Bearwalk said...

Looks good as is to me. Thanks for the trouble"