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EXCLUSIVE: Botox Maker Answers FDA

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Although Allergan’s popular drug, Botox, is probably best known as an anti-wrinkle treatment, it's also used in the treatment of some very serious medical conditions.

Recently Botox (and a competitor) were linked to dangerous botulism symptoms in some patients, explains Dylan Ratigan, where the toxin spread beyond the injection site to other parts of the body, paralyzing the muscles used for breathing and swallowing, a potentially fatal side effect.

Allergan CEO David Pyott joins the panel to respond to claims that Botox may be unsafe. Following is a synopsis of his main points.

What do you know about the investigation?

“Allergan and Botox have a really strong safety record of almost 18 years of this product being used not only in cosmetic uses but in almost 20 licensed medical (uses) in millions of patients,” replies Pyott.

“The way to think about this, he says, is the FDA is conducting a labeling review. It does not concern general Botox safety issues. However within a very small population of juvenile cerebral palsy patients they think they may have seen severe adverse events."

Are there any indications that Botox as a cosmetic injection has had any similar effect?

“Botox (used for cosmetic purposes) is used in very different doses,” replies Pyott. “When we look at Botox cosmetic, typically a patient will receive 20 units or 1/5 of a bottle for the treatment of lines between the brows. But in (cerebral palsy cases) submitted to the FDA up to 40 units were used."

Ultimately how much of a barrier does this present in getting Botox approved for things it’s not already approved for?

"For us, it will give us a strong motivation to re-look at the trials for juvenile cerebral palsy," says Pyott, "because in the past we didn’t think we could afford to re-do the trials. But this may well cause us to review that decision."

Did you know about this when you were on Squawk Box the other day?

"No we found out about it Thursday," replies Pyott. "This is really a very routine matter where the FDA is constantly considering whether a label review is merited. And in fact we had already been submitting information to the FDA as part of that review."

Do you think the stock market reacted appropriately by taking the stock down?

“Unfortunately, that’s the way markets react,” says Pyott. “People don’t always understand the news and don’t get the real facts. I think (the FDA scrutiny) is all about a labeling review and we stand behind the strong safety record of Botox over the past 18 years and it’s wide use.”

Traders, what are your thoughts?

I think the market overreacted, says Pete Najarian. It’s awful that children died but I don’t think it’s going to affect the stock

Read More

> Botox Linked To Deaths In Children

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Trader disclosure: On Feb.8, 2008, the following stocks and commodities mentioned or intended to be mentioned on CNBC’s Fast Money were owned by the Fast Money traders; Macke Owns (INTC), (YHOO), (DIS); Najarian Owns (AMR), (C), (CSCO), (EBAY), (MCD), (MS), (MSFT), (XLF), (YHOO), (BIIB); Najarian Owns (FRE) Puts, (AIG) Puts; Najarian Owns (CNET) Calls, (AAPL) Calls, (NWA) Calls, (SKS) Calls; Finerman Owns (GS); Finerman's Firm Owns (GE), (JCP), (MSFT), (SKS), (WMT), (YHOO), (AAPL), (MO); Finerman's Firm Is Short (IWM), (IJR), (IYR), (MDY), (SPY), (COF); Finerman's Firm Is Short (LEH) And Owns (LEH) Puts; Finerman's Firm Owns (CROX) And (CROX) Calls, ; Finerman Owns (CROX) And (CROX) Calls; Finerman's Firm Is Short (RTH), (SPG), (TCO)