Virecept: ALERT!

[newt]

Cancer alert (sic) over anti-HIV drug

Roche has received several reports that some batches of Viracept tablets have a "strange odour".

Said Roche: "A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester."  <<< erm, not nice but you need a lot to cause cancers, the possibility the BBC headline jumps on.

Nonetheless, Roche is kinda doing a product recall ie see yo doc asap. 

I am not surprised there are 500+ people using this old, old drug in the UK, it's well understood in pregnancy.

- matt

[frenchpat]

More about same:


http://www.guardian.co.uk/uk_news/story/0,,2096925,00.html

http://www.reuters.com/article/governmentFilingsNews/idUSL0633813920070606

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

this apparently does not concern the US but mostly Europe



hope this helps

Pat

[Jacques]

The US, Canada and Japan are not affected by this recall.


Jacques

[Cerrid]

Basel, 06. June 2007

Roche recalls Viracept due to chemical impurity
Patients are requested to contact their doctors to discuss alternative therapies

Roche, in  agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall.

Roche has received several reports that some batches of Viracept 250 mg tablets have a strange odour. A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester. In the interest of patients safety Roche has decided to recall all batches of Viracept tablets and powder.

Patients are requested to contact their doctors to discuss alternative therapies.

About Viracept
Viracept (nelfinavir), a protease inhibitor is supplied by Roche outside the US and Canada. Viracept was first introduced by Roche in 1998.

Roche press release

[Ann]

Cerrid,

I merged your thread on Viracept with the one Newt started yesterday, so we can keep the discussion all in one place.

Ann

[frenchpat]

An interesting, if worrying, development:

http://www.trt-5.org/article143.html

and

http://www.trt-5.org/IMG/pdf/TRT5-lettre_Roche_vf200707.pdf

Pat

edited to add second link

[newt]

This is a somewhat alarmist link (above). 

The European Medicines Agency (EMEA) has asked Roche to do specific animal studies on the safety and toxicity of EMS. A patient register is being set up also.

EMEA questions and answers on the nelfinavir recall

- matt

[frenchpat]

Sorry,
I didn't mean to alarm anybody, but this was the first I read about the contamination not being new.

TRT5 (who wrote the press release and the letter) is a reliable source of information for hiv patients. Perhaps the tone stems from the fact that it was released in Sydney at the Aids meeting and they want to put pressure on Roche.

Pat

[newt]

This is a summary of a meeting with Roche yesterday about the nelfinavir contamination with EMS (as reported by by Simon Collins of HIV i-Base and quoted nearly verbatim from his email to the UK CAB email list):

"This is only a quick summary ... Countries directly affected from the batches are: Botswana, Burkina-Faso, Cameroon, Egypt, France, Germany, Iran, Italy, Kenya, Mali, Mexico, Mozambique, Nigeria, Portugal, South Africa, Spain, Taiwan, Uganda, Ukraine, UK.

"Roche can only give a rough estimate of how many people this might affect because they only know the quantity of drug sold - not whether it is used for treatment, short course PEP, pregnancy etc. The estimate is that this may affect up to 20,000 people.

"Roche commit to providing us with a rough idea of what percentage of batches were contaminated in each country above (ie was 100% of UK NFV contaminated or only 5% of batches) ... about 8 batches [manufactured] had much higher levels of EMS. It is not straight forward that just these batches are affected because apparently drugs from different batches are mixed to other batches. All contaminated batches form this period have been tracked though to final drugs produced.

"However, given that Roche's licence has been suspended by the EMEA, distribution of nelfinavir is completely stopped including for all countries where there was no contamination. This is clearly cause major problems for people in any country when NFV was widely used. For many countries this is their main second line treatment. This estimate is also around another 20,000 people.

"There is very little data on toxicity risk of EMS, and none in humans. In rats and mice at exposures 200 x times the maximum expected from this manufacturing problem, the compound is clearly genotoxic (ie gets into DNA and mistakes made by DNA can induce cancers).  However, EMS is guickly degraded by the body and can't be detected after a few hours.

"[A]n in vitro study published earlier this year in human cells looking at toxicity of a similar compound, where they showed that toxicity may not be immediate from any exposed dose. Instead, low exposures may have no effect until a certain minimum concentration is reached and then toxicicty increases.

"Two registries are being set up to look at whether anyone was harmed form the exposure to EMS: 

"(1) to include all patients who used NFV from March to June 2007 in the countries affected

"(2) to look at all NFV-use in pregnancy, children and exposed but not infected children since the drug was approved in 1998.  This is because there is a chance that previous batches of NFV included EMS.

"Apparently the EMEA warned of this risk back in 2001, and when production was checked, levels were below any minimum concern (less than 1 part per million). It is not clear why this didn't become part of the routine batch of safety tests from then on.

"Paediatric formulations - powder: none of the contaminated batches, by chance, were used in production of paediatric powder - though many children split off/crush tablets rather use the powder which is very bulky"

A PowerPoint slide set will be available from the meeting and I will post a link to this cos it will go on the web somewhere.

(edited for spelling a bit)

- matt