Sanofi-Aventis Cynomel Supply Difficulties

[helvella]

The letter below (which has been automatically translated) gives some information about the shortage of Sanofi Aventis Cynomel. As usual with such translation, the language is a bit odd but appears to make sufficient sense.

There is a link to the original French PDF at the end, should you wish to view it.

Page 1

IMPORTANT PRODUCT INFORMATION

Gentilly, July 30, 2020

For the attention of hospital and private endocrinologists, general practitioners, hospital pharmacists and dispensing pharmacists

Subject: Supply tensions for CYNOMEL 0.025 mg, scored tablet

Madam, Sir, Dear Confrere,

We are faced with industrial difficulties at our manufacturing site which limits our ability to regularly supply lots on the market. These difficulties consequently lead to supply tensions in our specialty:

CYNOMEL 0.025 mg, scored tablet

Box of 30 scored tablets - CIP: 34009 302 775 5 3

This specialty is indicated in the replacement treatment of hypothyroidism in the event that a rapid or transient effect is desired (life-threatening hypothyroidism, short-term replacement therapy before administration of iodine-131 in patients with usually treated with levothyroxine), adjunct therapy for suppressing TSH secretion in some TSH cancers dependent, certain simple goiter and certain nodules and the adjunct treatment in the treatment of peripheral resistance to thyroid hormones.

Thus, given the essential nature of this specialty for patients whose treatment has been initiated beforehand, and in order to better manage the residual stock available in very limited quantities, we ask prescribing doctors not to initiate CYNOMEL 0.025 mg, scored tablet in new patients in order to allow the continuation of treatment to patients already treated.

A limited distribution is organized to reserve the use of units of CYNOMEL 0.025 mg, scored tablet at any continuation of treatment already in progress.

Therapeutic alternatives exist depending on the indication.

In order to proceed with this medical quota, it is requested:

- For prescribing physicians to specify the words "renewal of treatment"

- Pharmacists to send the prescription with the mention "renewal of treatment" by email to the address: [e-mail] .

Also, for any troubleshooting request, we invite you to contact our Medical and Scientific Information Department of

Monday to Friday from 9 a.m. to 6 p.m. at the following numbers:

- From the metropolis:

- From the DROM-COM:

We make every effort to resolve these supply difficulties. We are not, however, in a position to stage to communicate to you a date of normal availability of this specialty.

Aware of the inconvenience caused, we thank you for your understanding and ask you to believe, Madam, Sir and Dear Confrère, to the assurance of our best regards.

Nathalie Le Meur

Nadir Mahloul

Head Pharmacist

Medical Manager

Original French language PDF:

ansm.sante.fr/content/downl...

Link to Sanofi webpage about Cynomel:

ansm.sante.fr/S-informer/In...

Abi-Abster RedApple

[munroie]

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