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Wednesday, May 06, 2009

Who is responsible? The Sinepin Fiasco

Nursing Times reports that batches of the tricyclic antidepressant, Sinepin, have had to be recalled because they have been incorrectly labelled in Braille!

The Sinepin [Doxepin] 50mg cartons, with the batch number 0901001, have an error in the Braille print on the front of the carton.

The Braille on the front of the carton states ‘Sinepin 25mg’ - which should actually read ‘Sinepin 50mg’.

Sinepin capsules contain the active ingredient doxepin, which is a type of medicine called a tricyclic antidepressant (TCA). This type of medicine acts on nerve cells in the brain.

Side effects include:

Difficulty in passing urine

Drop in blood pressure when going from lying or sitting to sitting or standing, causing dizziness and lightheadedness (postural hypotension)

Involuntary muscle movements such as tremors or twitching

Confusion or delirium

Sexual problems

Taste disturbances

Low blood pressure (hypotension)

Disturbances in the normal numbers of blood cells in the blood

Abnormal heart beats

Faster than normal heart beat (tachycardia)

Convulsions (fits)

The article on the Nursing Times website states:

"Pharmacists have been asked to contact visually impaired customers to make them aware of the issue."

The MHRA website, as of 21.35, 6th of May 2009 carries the Drug Alert:

Dear Healthcare Professional,

Marlborough Pharmaceuticals Ltd

Sinepin Capsules 50mg

Doxepin Capsules 50mg

PL 23138/0003

Marlborough Pharmaceuticals Ltd have informed us that packs of Sinepin 50mg from the above batch have an error in the Braille print on the front of the carton. The Braille embossed on the carton states ‘Sinepin 25mg’. This is incorrect and it should state ‘Sinepin 50mg’

The error affects only packs of 50mg capsules imprinted with batch number 0901001. All other batches are unaffected. We understand that the company has re-worked stocks of batch 0901001 which had not yet entered the supply chain. This stock will be distributed as batch number 0901001A and is not affected by this notification.

Pharmacists are asked to contact any visually impaired customers who may have received this batch to make them aware of this issue. Alternative batches of Sinepin 50mg capsules are available; therefore batch 0901001 should not be dispensed to anyone who relies on Braille for the identification of the product.

Further Information
For further information, please contact Marlborough Pharmaceuticals Ltd, tel 01672 514187, e-mail

Primary Care Trusts are asked to bring this information to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

I'm dumbfounded by this lapse in the drug regulatory system. What's the betting that nobody will hold up their hand and take responsibility?



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