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ACNE DRUG WITH DISASTROUS SIDE EFFECTS FINALLY REMOVED FROM MARKET BY MANUFACTURER

I was amazed to learn how many people were damaged by this drug. Over the years we have helped hundreds with a variety of skin conditions including Psoriasis, Eczema, Acne and many others. Don’t let someone you know become a statistic like this.

On June 29, 2009, the manufacturer of the acne drug Accutane® accounced that it was removing the drug
from the market. Hoffmann-La Roche Inc. informed the FDA that it was “delisting” the drug as the patent
had expired and competing companies could provide the market with the drug. The company also stated
that the change was “not being taken for reasons of safety or efficacy.”
But this is the drug that carries warnings of birth defects and serious mental health problems. The
prescribing information for Accutane (with its active ingredient isotretinoin) warns of “depression,
psychosis (seeing or hearing things that are not real), suicide – some patients taking isotretinoin have had
thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people
tried to end their own lives. And some people have ended their own lives.”
Throughout the effective life of this drug, the FDA has gone to enormous effort to keep it on the market. In
2002 testimony, Janet Woodcock, M.D., the Director Center for Drug Evaluation and Research of the FDA,
described the steps the agency had taken to ensure consumers were protected (at taxpayer, not
pharmaceutical company expense):
• Publication of a “Medication Guide” and “Informed Consent” documents that explain the benefits and
risks of taking Accutane
• An Accutane Drug Information webpage on FDA’s website
• FDA Consumer Magazine article in March 2001 discussing the risks and benefits of Accutane in
layman’s language
• Development with the manufacturer of a new brochure for prescribers entitled: “Recognizing Psychiatric
Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane.”
• Submitting scientific papers for publication in the professional literature that included a scientific
evaluation of studies of psychiatric events resulting from the drug.
The FDA went to all this work and expense (and more not listed here) for a drug for which, in 2002, the
most frequently reported reactions were depression, induced abortion, suicidal ideation, and headache. A
2002 report also noted 172 babies born with a congenital defect or anomaly related to Accutane use, and
173 reports of suicide.
Finally, Accutane is off the market! Unfortunately, the reason is simply that Hoffman-LaRoche does not
now make enough money off the drug to defend itself against all the lawsuits that have resulted from its use.
And also unfortunately, there are three other manufacturers who are making medications that contain
isotretinoin. So the disastrous side effects will continue until the ingredient itself is banned.

Source: Hoffman-LaRoche, “Roche Discontinues and Plans to Delist Accutane in the U.S.,” June 29, 2009, http://www.rocheusa.com/portal/synergy/
static/file/synergy/alfproxy/download/1414-cd2ddc12b4d211deadd62f6357bc6b3c/last/roche%20discontinues% 20and%20plans%20to%20delist
%20accutane%20in%20the%20u.s..pdf
Source: Food and Drug Administration, “Concerns Regarding Accutane,” December 11, 2002, http://www.fda.gov/NewsEvents/ Testimony/ucm115126.htm
Source: Food and Drug Administration, “Deferral of Blood Donors Who Have Received Accutane,” February 28, 1984, http://www.fda.gov/downloads/Biologics
BloodVaccines/GuidanceCompliance RegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM063019.pdf

Dr. Shapero can help you.

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