(12-06-10) FDA: Potential Liver Failure Risk With Weight-loss Drugs

(RTTNews) - Obesity, a public health epidemic is growing at an alarming rate
not only in developed countries but in developing nations as well. The market
for anti-obesity drugs is virtually untapped and continues to hold a glittering
allure. Till date, there has been no 'silver bullet' remedy for obesity.
The drug therapy for the treatment of obesity has a checkered past. A couple
of approved diet drugs have been recalled, following reports of adverse side
reactions like heart damage, and some obesity drugs have gone belly-up in
clinical testing. A really effective and safe weight-loss therapy is long
overdue.
Abbott Laboratories' (ABT) Meridia and Roche's Xenical are the only two FDA-
approved prescription anti-obesity drugs currently on the market.
GlaxoSmithKline plc's (GSK) Alli is the only FDA-approved, over-the-counter
weight-loss product.
The safety and efficacy of Meridia have been questioned by its opponents ever
since reports of adverse reactions to the diet drug surfaced in 2002. That
year, the consumer-protection group Pubic Citizens petitioned to the FDA to
recall Meridia saying that the risk of use outweighed the benefit, and
described the drug as "unacceptably dangerous."
However, the regulatory agency has refused to ban Meridia saying "overall risk-
benefit profile supports it remaining available as a prescription drug for the
treatment of appropriately selected obese patients." The FDA has strengthened
the warnings in Meridia's labeling.
Now, Roche's Xenical and GlaxoSmithKline's Alli have also come under
regulatory scanner.
The FDA has cautioned that there is a potential, rare occurrence of liver
failure in people who take the weight-loss medications Xenical or Alli, both of
which contain the active ingredient orlistat. At least 12 cases of severe liver
injury have been reported in people taking Xenical and one case has been
reported with the use of Alli.
Though the cause-and-effect relationship of severe liver injury with orlistat
use has not been established, the FDA has revised the drug labels for Xenical
and Alli to include new safety information about the rare occurrence of severe
liver injury.
Arena Pharmaceuticals Inc. (ARNA), Orexigen Therapeutics Inc. (OREX) and Vivus
Inc. (VVUS) are the three companies which are currently in the race to find a
prescription diet drug. The FDA is expected to make a final decision on whether
or not to approve Arena's weight-loss drug Lorcaserin by October 22 and
Orexigen's Contrave and Vivus' Qnexa by October 28.
The market for anti-obesity drugs has a huge untapped potential and there is
enough room for all the players. But the first company to hit the market with a
safe and effective weight-loss drug could reap huge profits.


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In evidenza

"L'informazione presente nel sito serve a migliorare, e non a sostituire, il rapporto medico-paziente."

Per coloro che hanno problemi di salute si consiglia di consultare sempre il proprio medico curante.