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used as a last re sort treat ment due to dan ger ous SE agran u lo cy to sis. The FDA has added a warn ing of
increased risk of hyperglycemia and diabetes with Clozaril and all atypical antipsychotics.
In 2005, the FDA re quested that all man u fac tur ers of atyp i cal antipsychotic drugs, in clud ing Clozaril, add
a boxed warn ing high light ing the in creased risk of death when these prod ucts are used off-la bel to treat
be hav ioral dis or ders in el derly pa tients with dementia.
Clin i cal Data: Clozaril has a risk of caus ing the po ten tially fa tal side ef fect of agran u lo cy to sis and blood
mon i tor ing is re quired with use of the drug. How ever, Clozaril is re ported to have shown to have a sig nif i -
cantly lower in ci dence of agran u lo cy to sis than first ex pected. A study showed that the av er age in ci dence
was 0.38%, whilst 1-2% had been pre dicted. It was re ported by Swe den’s Ad verse Re ac tions Ad vi sory
Com mit tee in 2000, that Clozaril may be linked to ve nous thromboembolism and, in 2002, Novartis
alerted doc tors to a po ten tially fa tal heart con di tion, myocarditis, linked to use of the drug.
Novartis has con ducted a trial com par ing the ef fects of Clozaril with Lilly’s Zyprexa (olanzapine) on the
risk of sui cide and self-de struc tive be hav ior in pa tients with schizo phre nia and schizoaffective dis or der,
the In ter na tional Sui cide Pre ven tion Trial (InterSePT). Re sults were pub lished in 2003 in the Ar chives of
Gen eral Psy chi a try. The study found that Clozaril can re duce by up to 26%, the risk of re cur rent sui cidal
be hav ior and sui cide at tempts among peo ple suf fer ing from schizo phre nia or schizoaffective dis or der.
The study is the first ever to pro spec tively dem on strate ef fi cacy of a med i ca tion to affect suicidal behavior
in any patient group.
Ac cord ing to re sults of a 50-pa tient, 10-week trial, pub lished in Neu rol ogy in 2004, low-dose clozapine is
ef fec tive in treat ing dyskinesias (in vol un tary move ments) re sult ing from long-term levodopa ther apy in
pa tients with se vere Par kin son’s disease.
Com pe ti tion: Clozaril is now sub ject to ge neric com pe ti tion in the USA, as its pat ent ex pired in 1995. It
poses a chal lenge to ge neric man u fac tur ers, as any one wish ing to mar ket a ge neric ver sion would also
have to ar range for a mon i tor ing sys tem to be used with it. How ever, Teva (Is rael) has launched a ge neric
version of clozapine.
In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, the num ber one prod uct in the
antipsychotics cat e gory was AstraZeneca’s Seroquel (quetiapine), with a 23.2% mar ket share and 7%
fixed rate dol lar growth. Num ber two was Lilly’s Zyprexa (olanzapine), with a 22.2% mar ket share, but
sales down 2% in fixed rate dol lar terms. Num ber three was J&J’s Risperdal (risperidone), with a 19.8%
mar ket share but sales down 10% in fixed rate dol lar terms. Num ber four was Otsuka’s Abilify
(aripiprazole), with a 14.7% mar ket share and 27% fixed rate dol lar growth. Pfizer’s Zeldox
(ziprasidone) was num ber five, with a 5.1% mar ket share and 16% fixed rate dol lar growth. J&J’s
Invega (paliperidone) was num ber six, with a 1.4% mar ket share and 203% fixed rate dol lar growth.
Teva’s ge neric risperidone prod uct, Risperidone Teva, was num ber seven, with a 1% mar ket share.
Leponex (the of fi cial IMS in ter na tional prod uct name for Clozaril) was in eighth place, with a 1.0% mar -
ket share, but sales down by 6% in fixed rate dol lar terms. Teva’s ge neric clozapine (Clozapine Teva)
was at num ber ten, with a 0.3% mar ket share and 2% fixed rate dol lar growth. Teva also mar kets a ge -
neric ver sion of olanzapine, which was in num ber 12 po si tion in this class in the pe riod, with a 0.3%
market share but sales down 2%.
RITALIN (methylphenidate), a mild psychostimulant in di cated in the treat ment of at ten tion def i cit/hy -
per ac tiv ity dis or der (ADHD) in chil dren, first launched in 1954, and now avail able world wide. A sus tained
re lease ver sion, Ritalin-SR, is avail able but it has only cap tured a small mar ket share; an a lysts say that
al though ad ver tised as an 8-hour drug, it only ac tu ally works for around six hours (con ven tional Ritalin
lasts for four hours). It is also ab sorbed more slowly, but not as ex ten sively as Ritalin. As a re sult, the SR
ver sion has less pre dict able ab sorp tion in the body. An ex tended-re lease once-daily ver sion, Ritalin LA,
was ap proved by the FDA in 2002. Ritalin prod uct la bel ing was changed in 1996 to in clude the fact that it
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