FDA Warns Allergan Inc For Misrepresentation of True Aczone Results

On the 17th August 2009, the Division of Drug Marketing, Advertising and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) sent a warning letter to Mr E.I. Pyott Chairman and CEO of Allergan Inc, for false and misleading advertising of its Aczone (Dapsone) Gel 5% acne product.

The FDA informed Mr Pyott that the Journal Advertisement overstated the efficacy of Aczone and it omitted important risk information associated with its use. As a result it violates the Federal Food, Drug and Cosmetic Act.

Actual Results Shows Aczone Does not Work as Claimed

Allergen stated in their Journal Ad that Aczone works fast by reducing inflammatory lesions by 24% within 2 weeks. The FDA stated that this was a complete misrepresentation of the true results; which showed that patients using a placebo experienced a 22% inflammatory reduction within 2 weeks.

This insignificant 2% margin shows that Aczone is no better at reducing inflammatory lesions than using nothing at all.

Omission of Risk Information

The FDA also informed Mr Pyott, that Allergan Inc. had omitted the risk information in their Ad, that using Aczone Gel followed by benzoyl peroxide can cause a temporary yellow or orange discoloration of the skin and hair.

Immediate Action Demanded By the FDA

The DDMAC informed Allergan that this is a serious matter and they must immediately cease with their advertising and promotional materials that violate the FDA Drug And Cosmetic Act.

Allergan were also requested for an immediate reply to the FDA informing them of what actions have been taken to resolve this serious situation. And a comprehensive plan on how they shall inform the public of the true results. This they must comply to by the 28th August 2009.

The Rosacea Acne Times was able to obtain a copy of this 5 page warning fax sent from the FDA to Mr Pyott, that details the complete facts and the actual research study results.

Controversial Acne Product Accutane Withdrawn From US

Roche Pharmaceuticals on the 2nd July 2009 notified the US Food and Drug Administration (FDA) that they were withdrawing their anti-acne drug Accutane which contains Isotretinoin, from the US market. Roche claimed that it had nothing to do with the thousands of personal injury cases against them, it is purely a commercial decision as sales have plummeted to a 5 per cent market share.

Then, just few days later on the 7th July 2009, Ranbaxy Laboratories who have the largest US market share with 30 percent, announced that they were also withdrawing their Isotretinoin based product, Sotret from the US market.

*For the remainder of this article I will refer to Isotretinoin drugs as Accutane for simplicity and because Isotretinoin is such a mouthful to say.

A Highly Controversial 27-Year History

Roche introduced its patented anti-acne drug Accutane in 1982. And since then more than 13 million people have been treated with it. However, during this period Roche has been hit with more than 5,000 personal injury claims, with many still pending.

On the 22nd of April 2008, $10,5million was awarded by a New Jersey Jury to a woman who developed a serious inflammatory bowel disease caused by taking Accutane.

What is Accutane?

Accutane was discovered in 1979 and was released as an oral drug in pill form. It is only prescribed to severe acne cases that did not respond to other acne treatments. Patients undergoing Accutane treatment are closely supervised by a physician and frequent blood tests are taken. The maximum time of the treatment is restricted to 6-months.

The results were dramatic and amazing to say the least. In 95 per cent of the severe acne cases, a permanent clearing of acne symptoms was seen over a 3 – 5 month period. However, in 25 percent of these, the acne did return after about a year, and a further 6-month course of Accutane had to be endured.

How Does Accutane Cure Acne?

• Accutane reduces the size of the skin’s oil glands by up to 58 per cent. As a result the skin’s oil (Sebum) production is reduced by up to 80 per cent.
• This extreme reduction in skin oil dramatically reduces the amount of skin acne bacteria (p.Acnes), which live in this skin oil.
• Accutane slows down the skin cell re-newel process, which in turn reduces the amount of dead skin cells being shed. This is the key to success, as acne is caused by dead skin cells getting trapped in excessively oily pores, which then become clogged entrapping the bacteria within. The bacteria would then infect the clogged pore and it would become swollen and inflamed, resulting in a newly formed pimple or a spot or zit as it is known in colloguial terms.
• Accutane also has anti-inflammatory properties, which helps to reduce the swelling and inflammation.

Other Alarming Serious Side Affects Caused By Accutane

The list of side effects caused by this drug is almost endless, with the most serious being; suicidal thoughts, birth defects, depression, psychosis, gastrointestinal disease, bone muscle and visionary problems.

Where Does This Leave Severe Acne Sufferers If Removed?

As Accutane is the last resort in acne treatment, what hope is there for severe sufferers if it is removed?

Roche Holding AG, said that it was only pulling Accutane from the US market, and it is still available in other countries. Furthermore, there are still other generic versions (trade names) of Accutane available, such as Claravis and Amnesteem in the US – for the time being?

Is There A Safe Alternative To Accutane?

Yes there is, Vitamin B5, which is a safe and natural ingredient that qualifies to take over the Throne vacated by Accutane. In clinical tests only minor side effects such as diarrhea have been noted in some cases.

Vitamin B5 is known by its scientific name as (d-Calcium Pantothenate) and was discovered in 1997 by Dr Lit-Hung Leung, who presented his research on how it cures and prevents acne.

These remarkable results astonished the global scientific fraternity. But, the US medical profession has been slow to acknowledge its amazing potential of this very safe and effective acne cure, and to date it has still not been approved by the FDA.

Accutane type drugs are slightly more effective than Vitamin B5, because the active ingredient Isotretinoin shuts down skin oil production totally, whereas natural Vitamin B5 only prevents excess oil from being produced.

Conclusion

We believe that the withdrawal of Accutane and Sotret by Roche and Ranbaxy respectively, is the beginning of the end for Isotretinoin anti-acne drugs worldwide. The risk factor is too high when weighed against the benefits, and of course the law suits are becoming too expensive.

We believe that Roche could not have removed its product globally, as this would have been an admission of guilt that its product is not safe. In turn this would have weakened their defense against pending law suits.

One point we do stress is that if you are suffering from severe acne, we recommend that you seek the advice of your Physician or Dermatologist before embarking on any acne treatment, especially oral ones. We are though fairly positive that your physician will recommend that you should try a Vitamin B5 supplement – there is no danger only benefits. Also many physicians and dermatologists around the globe have put their names and reputations to this treatment.

For more information about Vilantae a remarkable naturally safe Vitamin B5 treatment, see our page

http://acne.carecenterlink.com/vilantae-review