Recent MHRA Drug Alerts (counterfeit and contaminated products)

Over the last few weeks we have issued several  Drug Alerts, four recalling counterfeit batches of products (Zyprexa, Plavix and Casodex) from the market, and one recalling all batches of a contaminated product (Viracept), to minimise the risk to patients. We have also issued a Drug Alert concerning a fake toothpaste being sold in unauthorised markets and discount shops.

Counterfeit products
The MHRA has recently been alerted to several counterfeit products and we have issued the following five Drug Alerts:

 

Date	Product	Batch number(s)	Drug Alert
24 May 2007	Zyprexa (olanzapine) 10mg	A200127 A216454 A229505	EL(07)A/06
25 May 2007	Plavix (clopidogrel) 75mg	3098 6Y098	EL(07)A/07
1 June 2007	Casodex (bicalutamide) 50mg	65520	EL(07)A/08
4 June 2007	Plavix (clopidogrel) 75mg	3103/1 to 3103/20 inclusive	EL(07)A/09
12 July 2007	Sensodyne Original and Sensodyne Mint 50ml Tubes	Fake batch PROD 07 2005 / EXP 08 / 2008	EL(07)A/13

Patients should contact their pharmacist as soon as possible if they are taking any of these medications with the above batch numbers. They should take their medication with them so their pharmacist can return it to the manufacturer for examination. At present, there is no evidence of patients having any adverse reactions specifically related to any of these counterfeit batches. Patients should should consult their GP if they have any treatment or health concerns.

Sensodyne Original and Sensodyne Mint in 50ml tubes
GlaxoSmithKline have informed us that fake toothpaste products in combined Arabic with English livery packs have been sold in unauthorised markets and discount shops and are a potential danger to public health. Tests indicate that the products contain Diethylene Glycol at levels which could be toxic to young children and anyone with impaired liver or kidney function. If people have toothpaste from the fake batch they should stop using it, discard it and buy a replacement from an authorised stockist.

We are taking these cases very seriously and criminal investigations are currently taking place. For further information on how we are tackling the problem of counterfeit products, please see the following section:
› How we are tackling counterfeit medicines and devices

Contaminated product
The MHRA were informed of contamination with a genotoxic substance affecting the production of all batches of the medicine Viracept (nelfinavir mesilate). This medicine is an antiretroviral agent for use in first-line HIV therapy. The MHRA, in conjunction with the European Medicines Agency (EMEA) and Roche, issued the following Drug Alert to recall this medicine from the market, to minimise the risk to patients:

Date	Product	Batch number(s)	Drug Alert
6 June 2007	Viracept (nelfinavir mesilate)	All	EL(07)A/10

Patients prescribed Viracept should contact their doctor immediately. They will have to change to another appropriate medicine for their condition. 

EMEA action plan - 21 June 2007
The EMEA released an action plan on 21 June detailing the steps that the manufacturer will undertake to follow up patients who may have been affected:
›  EMEA press release: European Medicines Agency agrees on action plan following the recall of Viracept and recommends suspension of the Marketing Authorisation (external link)

We are writing to HIV specialists and to patient organisations to update them on this issue. Health professionals will be contacted in due course by the manufacturer. Any patient who is concerned should discuss with their doctor.