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Roche discontinues and plans to delist accutane in the u.s.

ROCHE DISCONTINUES AND PLANS TO DELIST ACCUTANE IN THE U.S.
June 29, 2009 -- Nutley, N.J.
Roche Discontinues and Plans to Delist Accutane in the U.S.
Hoffmann-La Roche Inc. has notified the U.S. Food and Drug Administration(FDA) of its intent to immediately discontinue the manufacture and distributionof Accutane® (isotretinoin), its ground-breaking treatment for severe recalcitrantnodular acne that has not responded to other therapies. This decision is beingtaken for business reasons during a reevaluation of our product portfolio ofmedicines that are now available from generic manufacturers, and is not beingtaken for reasons of safety or efficacy.
Since 2002, generic formulations of isotretinoin, the active ingredient inAccutane, entered the market. Current manufacturers/distributors are BarrLaboratories Inc., Genpharm, Inc. / Mylan Pharmaceuticals Inc., and RanbaxyLaboratories Inc. As a result, Roche’s prescription market share of Accutanehas steadily declined for several years and is now below 5 percent. Therefore,the generic companies can supply the market. In addition, Roche has beenfaced with high costs from personal-injury lawsuits that the company continuesto defend vigorously.
Roche stands behind the safety of Accutane and the rigorous risk managementprogram Roche developed over decades of cooperation with the FDA and theAmerican Academy of Dermatology. Currently, the iPledge pregnancy riskmanagement program is a model in the pharmaceutical industry. Roche iscommitted to working with the FDA and the isotretinoin generic manufacturersfor the eventual transition of Roche’s business responsibilities in iPledge to theremaining sponsors.
We are proud of Accutane, a product of original Roche research that has beenused in the treatment of severe recalcitrant nodular acne by more than 13million patients since it was introduced in 1982.
Please see complete Accutane prescribing information at and Contact
Shelley Rosenstock
Roche
973-562-2373

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SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
ISOTRETINOIN?
Isotretinoin is used to treat a type of severe acne (nodular acne) that has not beenhelped by other treatments, including antibiotics.
Because isotretinoin can cause birth defects, isotretinoin is only for patients who canunderstand and agree to carry out all of the instructions in the iPLEDGE program.
Isotretinoin may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth (miscarriage),
death of the baby, and early (premature) births. Female patients who are pregnant or
who plan to become pregnant must not take isotretinoin.
Female patients must not get pregnant:
If you get pregnant while taking isotretinoin, stop taking it right away and call
your doctor. Doctors and patients should report all cases of pregnancy to:
The iPLEDGE Program Pregnancy Registry at 1-866-495-0654 2. Serious mental health problems. Isotretinoin may cause:
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.
Stop isotretinoin and call your doctor right away if you or a family member
notices that you have any of the following signs and symptoms of depression
or psychosis:
Lose interest in activities you once enjoyed Become more irritable, angry, or aggressive than usual (for example, temper outbursts,thoughts of violence) Have a change in your appetite or body weight Start having thoughts about hurting yourself or taking your own life (suicidal thoughts) Start seeing or hearing things that are not real After stopping isotretinoin, you may also need follow-up mental health care if you had any of http://rocheusa.com/newsroom/current/2009/pr2009062601.html[9/25/2009 9:52:41 AM] ROCHE DISCONTINUES AND PLANS TO DELIST ACCUTANE IN THE U.S.
WHAT IS ISOTRETINOIN?
Isotretinoin is a medicine taken by mouth to treat the most severe form of acne (nodular acne)
that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin can
cause serious side effects. (See “What is the most important information I should
know about isotretinoin?”) Isotretinoin can only be:
Prescribed by doctors that are registered in the iPLEDGE program Dispensed by a pharmacy that is registered with the iPLEDGE program Given to patients who are registered in the iPLEDGE program and agree to do everythingrequired in the program WHAT IS SEVERE NODULAR ACNE?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can bethe size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.
WHO SHOULD NOT TAKE ISOTRETINOIN?
Do not take isotretinoin if you are pregnant, plan to become pregnant, or
become pregnant during isotretinoin treatment. Isotretinoin causes severe
birth defects. (See “What is the most important information I should know
about isotretinoin?”)
Do not take isotretinoin if you are allergic to anything in it.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING ISOTRETINOIN
Tell your doctor if you or a family member has any of the following health
conditions:
An eating problem called anorexia nervosa (where people eat too little) Tell your doctor if you are pregnant or breastfeeding. Isotretinoin must not be
used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and
non-prescription medicines, vitamins, and herbal supplements. Isotretinoin and
certain other medicines can interact with each other, sometimes causing serious side effects.
Especially tell your doctor if you take:
Vitamin A supplements. Vitamin A in high doses has many of the same side effects
as isotretinoin. Taking both together may increase your chance of getting side effects.
Tetracycline antibiotics. Tetracycline antibiotics taken with isotretinoin can increase
the chances of getting increased pressure in the brain.
Progestin-only birth control pills (mini-pills). They may not work while you take
isotretinoin. Ask your doctor or pharmacist if you are not sure what type you are using.
Dilantin (phenytoin). This medicine taken with isotretinoin may weaken your bones.
Corticosteroid medicines. These medicines taken with isotretinoin may weaken
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your bones.
St. John’s Wort. This herbal supplement may make birth control pills work less
effectively.
These medicines should not be used with isotretinoin unless your doctor tells
you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Donot take any new medicine without talking with your doctor.
HOW SHOULD I TAKE ISOTRETINOIN
You must take isotretinoin exactly as prescribed. You must also follow all the instructions of theiPLEDGE program. Before prescribing isotretinoin, your doctor will: Have you sign the Patient Information/Informed Consent (for all patients). Femalepatients who can get pregnant must also sign another consent form.
You will not be prescribed isotretinoin if you cannot agree to or follow all the
instructions of the iPLEDGE program.
You will get no more than a 30-day supply of isotretinoin at a time. This is to make sureyou are following the isotretinoin iPLEDGE program. You should talk with your doctoreach month about side effects.
The amount of isotretinoin you take has been specially chosen for you. It is based onyour body weight, and may change during treatment.
Take isotretinoin 2 times a day with a meal, unless your doctor tells you otherwise.
Swallow your isotretinoin capsules whole with a full glass of liquid. Do
not chew or suck on the capsule. Isotretinoin can hurt the tube that connects your
mouth to your stomach (esophagus) if it is not swallowed whole.
If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
If you take too much isotretinoin or overdose, call your doctor or poison control center
right away.
Your acne may get worse when you first start taking isotretinoin. This should last only ashort while. Talk with your doctor if this is a problem for you.
You must return to your doctor as directed to make sure you don’t have signs of seriousside effects. Your doctor may do blood tests to check for serious side effects fromisotretinoin. Female patients who can get pregnant will get a pregnancy test each month.
Female patients who can get pregnant must agree to use 2 separate forms of effective
birth control at the same time 1 month before, while taking, and for 1 month after taking
isotretinoin. You must access the iPLEDGE system to answer questions
about the program requirements and to enter your 2 chosen forms of
birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com
or call 1-866-495-0654.
You must talk about effective birth control methods with your doctor or go for a free visit to talkabout birth control with another doctor or family planning expert. Your doctor can arrange thisfree visit, which will be paid for by the company that makes isotretinoin.
If you have sex at any time without using 2 forms of effective birth control, get
pregnant, or miss your expected period, stop using isotretinoin and call your
doctor right away.
WHAT SHOULD I AVOID WHILE TAKING ISOTRETINOIN?
Do not get pregnant while taking isotretinoin and for 1 month after stopping
isotretinoin. (See “What is the most important information I should know
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about isotretinoin?”)
Do not breastfeed while taking isotretinoin and for 1 month after stopping isotretinoin.
We do not know if isotretinoin can pass through your milk and harm the baby.
Do not give blood while you take isotretinoin and for 1 month after stopping
isotretinoin. If someone who is pregnant gets your donated blood, her baby may be
exposed to isotretinoin and may be born with birth defects.
Do not take other medicines or herbal products with isotretinoin unless you talk
to your doctor. (See “What should I tell my doctor before taking isotretinoin?
)
Do not drive at night until you know if isotretinoin has affected your
vision. Isotretinoin may decrease your ability to see in the dark.
Do not have cosmetic procedures to smooth your skin, including waxing,
dermabrasion, or laser procedures, while you are using isotretinoin and
for at least 6 months after you stop. Isotretinoin can increase your chance of
scarring from these procedures. Check with your doctor for advice about when you can
have cosmetic procedures.
Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use
ultraviolet lights. Isotretinoin may make your skin more sensitive to light.
Do not share isotretinoin with other people. It can cause birth defects and other
serious health problems.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF ISOTRETINOIN?
Isotretinoin can cause birth defects (deformed babies), loss of a baby
before birth (miscarriage), death of the baby, and early (premature)
births. (See “What is the most important information I should know about
isotretinoin?”)
Isotretinoin may cause serious mental health problems. (See “What is the
most important information I should know about isotretinoin?”)
Serious brain problems. Isotretinoin can increase the pressure in your brain. This
can lead to permanent loss of eyesight and, in rare cases, death. Stop taking isotretinoin
and call your doctor right away if you get any of these signs of increased brain pressure:
Stomach area (abdomen) problems. Certain symptoms may mean that your
internal organs are being damaged. These organs include the liver, pancreas, bowel
(intestines), and esophagus (connection between mouth and stomach). If your organs
are damaged, they may not get better even after you stop taking isotretinoin. Stop taking
isotretinoin and call your doctor if you get:
Bone and muscle problems. Isotretinoin may affect bones, muscles, and ligaments
and cause pain in your joints or muscles. Tell your doctor if you plan hard physical
activity during treatment with isotretinoin. Tell your doctor if you get:
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A broken bone. Tell all healthcare providers that you take isotretinoin if you breaka bone.
Stop isotretinoin and call your doctor right away if you have muscle
weakness. Muscle weakness with or without pain can be a sign of
serious muscle damage.
Isotretinoin may stop long bone growth in teenagers who are still growing.
Hearing problems. Stop using isotretinoin and call your doctor if your hearing gets
worse or if you have ringing in your ears. Your hearing loss may be permanent.
Vision problems. Isotretinoin may affect your ability to see in the dark. This condition
usually clears up after you stop taking isotretinoin, but it may be permanent. Other
serious eye effects can occur. Stop taking isotretinoin and call your doctor right away if
you have any problems with your vision or dryness of the eyes that is painful or constant.
If you wear contact lenses, you may have trouble wearing them while taking isotretinoin
and after treatment.
Lipid (fats and cholesterol in blood) problems. Isotretinoin can raise the level of
fats and cholesterol in your blood. This can be a serious problem. Return to your doctor
for blood tests to check your lipids and to get any needed treatment. These problems
usually go away when isotretinoin treatment is finished.
Serious allergic reactions. Stop taking isotretinoin and get emergency care right
away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop
taking isotretinoin and call your doctor if you get a fever, rash, or red patches or bruises
on your legs.
Blood sugar problems. Isotretinoin may cause blood sugar problems including
diabetes. Tell your doctor if you are very thirsty or urinate a lot.
Decreased red and white blood cells. Call your doctor if you have trouble
breathing, faint, or feel weak.
The common, less serious side effects of isotretinoin are dry skin, chapped
lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any
side effect that bothers you or that does not go away.
These are not all of the possible side effects with isotretinoin. Your doctor or pharmacist cangive you more detailed information.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
HOW SHOULD I STORE ISOTRETINOIN?
Store isotretinoin at room temperature. Protect from light.
Keep isotretinoin and all medicines out of the reach of children.
GENERAL INFORMATION ABOUT ISOTRETINOIN
Do not use isotretinoin for a condition for which it was not prescribed. Do not give isotretinoin toother people, even if they have the same symptoms that you have. It may harm them.
This safety section summarizes the most important information about isotretinoin. If you would
like more information, talk with your doctor. You can ask your doctor or pharmacist for
information about isotretinoin that is written for health care professionals. You can also call
iPLEDGE program at 1-866-495-0654 or visit
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