The assessment affects nineteen centrally authorised medicines as well as various medicines that have been nationally authorised: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon, Herceptin, Invirase, Mabthera, Mircera, Neorecormon, Pegasys, Roactemra, Tamiflu, Tarceva, Viracept
, Xeloda, Xenical and Zelboraf.
The HIV drug was approved by the US Food and Drug Administration in 1997, and is sold under the brand name Viracept
Four people were taking two drugs with strong warnings about their combination--3 taking a PI plus Flonase (fluticasone, for nasal allergies or difficulty breathing) and 1 taking the PI Viracept
(nelfinavir) and a stomach acid controller.
Since the Viracept
case, however, genotoxic impurities are now more in the focus of the authorities.
If a trial had been launched in '97, he notes, "we would just be getting final results, and we would have a lot of information on d4T, Crixivan and Viracept
regimens [stavudine (Zerit), indinavir, and nelfinavir].
Table 1 Common Antiretroviral Drugs (14-16) Classification Generic Name Trade Name Nucleoside reverse Abacavir sulfate Ziagen transcriptase inhibitors Abacavir sulfate + Trizivir (NRTI) lamivudine + zidovudine Didanosine (ddl) Videx, Videx EC Lamivudine (3TC) Epivir Lamiudine + zidovudine Combivir Stavudine (d4T) Zerit Tenofovir disoproxil Viread fumarate Zalcitabine (ddC) Hivid Zidovudine (AZT, ZDV) Retrovir Non-nucleoside reverse Delavirdine mesylate Rescriptor transcriptase inhibitors Efavirenz Sustiva (NNRTI) Nevirapine Viramune Protease inhibitors (PI) Amprenavir Agenerase Indinavir sulfate Crixivan Lopinavir + ritonavir Kaletra Nelfinavir Viracept
Ritonavir Norvir Saquinavir Fortovase Saquinavir mesylate Invirase Fusion inhibitors (FI) Enfuvirtide Fuzeon
New York, New York), another protease inhibitor, because the Viracept
manufactured in Europe contained high levels of ethyl methane mesylate (EMS).
Add increasing regulatory pressure, coupled with the recent high profile recalls including Vioxx by Merck and Viracept
by Roche, and the scope and scale of the problem escalates dramatically.
Roche, in agreement and co-operation with health authorities (EMEA and Swissmedic), is recalling all batches of Viracept
powder and tablets in Europe and some other regions of the world.
Tests on batches of the drug Viracept
, whose generic name is nelfinavir, revealed higher than normal quantities of methane sulfonic acid ethyl ester.
The drug, Viracept
, which is used by more than 500 UK patients, was recalled because batches were found to contain too high a level of a chemical that can cause cancer.
For example, Brazil routinely threatens to nationalize pharmaceutical patents: Hoffman-LaRoce's viracept
in 2001, Merck's nelfinavir in 2003, Abbot's Kaletra in 2005.