Notification of product recall due to Class 1 drug alert

7 July 2007. Related: Treatment alerts.

IMPORTANT – Notification of product recall due to Class 1 drug alert

Dear Healthcare Professional

Further to the recent announcement regarding the recall of Viracept® (nelfinavir) we are writing to advise you of the actions you now need to take to ensure that all stocks of the following products are removed from the marketplace.

Please ensure that all stock (all batches) of the above product presentations is quarantined and returned to your point of purchase. This recall does not affect the US, Canada or Japan. If supplied by Roche directly, please use the attached Stock Return Form to arrange for stock to be returned to Roche for full credit.

If your organisation has supplied product on, you should contact all your customers/patients who have been supplied with Viracept®. This includes all patients who may have stock within shelf life and this is applicable to stock issued since 2004.

Further information on recommendations to Healthcare Professionals

1. When switching patients to an alternative, treatment choices should be individualised. Please see guidelines below as an aide to this medication switch.
2. Please inform your Health Authority and local Roche Drug Safety Department immediately of any unexpected adverse events from patients taking Viracept.
3. Please thoroughly check all stock of Viracept formulations in your practice and any inventory under your control. If you do have any Viracept formulation stock, contact your local Roche Company to arrange collection. Please see attachment 2 for UK arrangements.

Additionally several treatment guidelines are available to assist you in building medication combinations that help a patient achieve undetectable viral loads. These include:

1. Hammer S, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society – USA panel. JAMA, 2006;296:827-843
2. The Panel on Clinical Practices for Treatment of HIV Infection convened by the Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. May 4, 2006
   http://AIDSinfo.nih.gov (accessed August 10 2006).
3. Recommandations du groupe d’’experts sous la direction du Professeur Patrick Yeni réalisé avec le soutien du Ministère de la Santé des Solidarité Prise en charge médicale des personnes infectée par le VIH. 2006: 46.
4. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. British HIV Association HIV Medicine (2006) 7, 494.
   http://www.bhiva.org

Communication Information

For further information, please contact your local Roche Office in the UK:

Freephone 0800 3281 629

or the official Roche web site:

http://www.roche.com/med-cor-2007-06-06b

Please be assured that Roche is using its best efforts to resume the supply of Viracept on your market as soon as possible. We will continue to keep you informed as appropriate.

We apologise for any inconvenience that this recall causes you. We wish to confirm that Roche has the safety of all our patients as our outmost concern, and is fully engaged at the highest level to ensure continuity of supply of validated stock.

Comment

Roche urges patients taking nelfinavir to seek immediate advice from their healthcare professional about alternative therapies. If it is not possible for patients to contact their doctor, patients should contact their local HIV clinic for further advice.

Further information is likely to be released by Roche and the EMEA when available. A programme that identifies batches that contained higher doses and closely monitoring patients who received these batches is expected. Although the short-term risk is expected to be low, further animal studies to determine the relationship between exposure and toxicity have been requested, with preliminary results from these studies due by the end of the year.

Clearly these are very unusual circumstances and Roche are working closely with the EMEA to understand any potential risks.

Patients in the UK have many alternative options to nelfinavir. This may not be the case in other countries where access to second-line therapies is more restricted.

There are discussions about patient registries for all patients potentially exposed to nelfinavir containing ethyl methansulphate from March 2007, and a separate registry for pregnant patients, children (under 18 years), and children who may have been exposed in utero who took nelfinavir since the product was first granted in 1998 (in all countries in the EU).

At this stage Roche do not recommend contacting patients for these registries yet. “However if you do see any patients who fall into these categories then please keep a record of these patients’ details.”

Roche ask doctors to NOT send any data/patient information to Roche until asked to do so.

Roche has already found out that the higher level of EMS was seen in the batches of Viracept that have been released on the market since March 2007. “However, we have also looked at earlier batches, and found that some impurity, but at lower levels, had also happened in the past. At the moment, Roche is actively identifying which batches were affected, so that, in each country, patients who have taken these Viracept batches can be traced, identified and followed up. Since the recall, the toxicology data available have not changed and hence, with this current knowledge, Roche believe the risk from the impurity is low.”