Accutane Injuries

Synopsis of Prescription Drug Litigation

Accutane® (Isotretinoin): Manufactured by Hoffman LaRoche and approved by the FDA in 1982, isotretinoin. Other trade names include: Claravis (Barr), Amnesteem (Mylan), Isotane (Pacific Pharmaceuticals and Sotret (Ranbaxy). It comes in capsule form. In 2009, Hoffman La Roche discontinued the manufacture of Accutane citing their dwindling market share of the acne medication because of widespread generic brands. The medication that was introduced in 1982 has since treated over 13 million patients

Why is this medication prescribed?: Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics and topical creams. Isotretinoin is in a class of medications called retinoids meaning it is derived from Vitamin A. It works by slowing the production of certain natural substances that can cause pimples to form.

FDA indications: Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those female patients who are not pregnant, because Accutane can cause severe birth defects. Isotretinoin has also been used to treat certain other skin conditions and some types of cancer as an off label use. Accutane has a black box warning required by the FDA.

What you should know when taking Accutane: Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects (physical problems that are present at birth).

A special program called iPLEDGE has been set up to make sure that pregnant women do not take isotretinoin and that women do not become pregnant while taking isotretinoin. All patients, including women who cannot become pregnant and men, can get isotretinoin only if they are registered with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE and fill the prescription at a pharmacy that is registered with iPLEDGE. Do not buy isotretinoin over the Internet.

You will receive information about the risks of taking isotretinoin and must sign an informed consent sheet stating that you understand this information before you can receive the medication. You will need to see your doctor every month during your treatment to talk about your condition and the side effects you are experiencing. At each visit, your doctor may give you a prescription for up to a 30-day supply of medication with no refills. You must have this prescription filled within 7 days. If you do not have your prescription filled within 7 days and you are a woman who can become pregnant, you will not be able to get isotretinoin until it is time for your next office visit, 23 days after the 7 days have passed. If you are a man or if you are a woman who cannot become pregnant, you will need to visit your doctor again to talk about the safe use of isotretinoin and to get a new prescription. You may have the new prescription filled right away.

Tell your doctor if you do not understand everything you were told about isotretinoin and the iPLEDGE program or if you do not think you will be able to keep appointments or fill your prescription on schedule every month.

Your doctor will give you an identification number and card when you start your treatment. You will need this number to fill your prescriptions and to get information from the iPLEDGE website and phone line. Keep the card in a safe place where it will not get lost. If you do lose your card, you can ask for a replacement through the website or phone line.

Do not donate blood while you are taking isotretinoin and for 1 month after your treatment.

Do not share isotretinoin with anyone else, even someone who has the same symptoms that you have.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with isotretinoin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs), the manufacturer's website, or the iPLEDGE program website (http://www.ipledgeprogram.com) to obtain the Medication Guide.

Talk to your doctor about the risks of taking isotretinoin.

For female patients: If you can become pregnant, you will need to meet certain requirements during your treatment with isotretinoin. You need to meet these requirements even if you have not started menstruating (having monthly periods) or have had a tubal ligation ('tubes tied'; surgery to prevent pregnancy). You may be excused from meeting these requirements only if you have not menstruated for 12 months in a row and your doctor says you have passed menopause (change of life) or you have had surgery to remove your uterus and/or both ovaries. If none of these are true for you, then you must meet the requirements below.

You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You can also have a free visit with a doctor or family planning expert to talk about birth control that is right for you. You must use these two forms of birth control at all times unless you can promise that you will not have any sexual contact with a male for 1 month before your treatment, during your treatment, and for 1 month after your treatment.

If you choose to take isotretinoin, it is your responsibility to avoid pregnancy for 1 month before, during, and for 1 month after your treatment. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.

If you plan to use oral contraceptives (birth control pills) while taking isotretinoin, tell your doctor the name of the pill you will use. Isotretinoin interferes with the action of microdosed progestin ('minipill') oral contraceptives (Ovrette, Micronor, Nor-QD). Do not use this type of birth control while taking isotretinoin.

If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, rings, or intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive.
You must have two negative pregnancy tests before you can begin to take isotretinoin. Your doctor will tell you when and where to have these tests. You will also need to be tested for pregnancy in a laboratory each month during your treatment, when you take your last dose and 30 days after you take your last dose.

You will need to contact the iPLEDGE system by phone or the Internet every month to confirm the two forms of birth control you are using and to answer two questions about the iPLEDGE program. You will only be able to continue to get isotretinoin if you have done this, if you have visited your doctor to talk about how you are feeling and how you are using your birth control and if you have had a negative pregnancy test within the past 7 days.

Stop taking isotretinoin and call your doctor right away if you think you are pregnant, you miss a menstrual period, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the iPLEDGE program, the manufacturer of isotretinoin, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby's health will be used to help doctors learn more about the effects of isotretinoin on unborn babies.

For male patients: A very small amount of isotretinoin will probably be present in your semen when you take prescribed doses of this medication. It is not known if this small amount of isotretinoin may harm the fetus if your partner is or becomes pregnant. Tell your doctor if your partner is pregnant, plans to become pregnant, or becomes pregnant during your treatment with isotretinoin.

What is the most important information I should know about isotretinoin (Accutane)?

• Isotretinoin can cause severe, life-threatening birth defects. Never use isotretinoin if you are pregnant.
• Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin.
• Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.
• Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.
• Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.

Black Box Warning:

Lawsuits: Approximately 5,000 personal injury lawsuits have been filed against Roche Pharmaceuticals, alleging that Accutane caused the onset of bowel problems. Additional lawsuits have been filed against Roche Pharmaceuticals for adverse reactions to Accutane including suicide, psychiatric side effects, and various gastrointestinal disorders.

Accutane Lawsuit 2009: In June of 2009, Roche Pharmaceuticals pulled Accutane from the U.S. market. While the company cited growing competition from generics as a key reason for the pull, Accutane sales had declined dramatically as Roche suffered harsh criticism and a string of lawsuits filed by plaintiffs who claimed the company did not provide proper warning about the dangers of the medication.
Accutane Lawsuit 2010: In February of 2010, Roche was ordered to pay more than $25 million to a man who developed inflammatory bowel disease years after taking Accutane. The verdict was issued after an earlier decision forcing the company to pay the man $2.5 million was thrown out in a state appeals court

When to call the Venardi Law Firm: Accutane (isotretinoin) has many adverse side effects. If you are experiencing any of the more severe or permanent side effects described below, you should call the Venardi Law Firm for a free consultation. Most cases are taken on contingency.

The following permanent adverse effects have been known to persist even after discontinuing therapy:
alopecia (hair loss), arthralgias (joint pain), nyctalopia (decreased night vision), inflammatory bowel disease (both Crohn’s and Ulcerative Colitis), degenerative disc disease, keloids, bone diease, dry eyes and dry skin. High dosages can cause rosacea (a disease of severe facial skin redness and irritation). It is not known how these side effects can be permanent but several studies have shown that Isotretinoin induces apoptosis (cell death) in various cells. A recent study[44] about how pharmaceuticals have epigenetic effects (for example DNA methylation) mentions Isotretinoin

Crohn's disease and ulcerative colitis

Several scientific studies have posited that isotretinoin is a possible cause of Crohn's disease and ulcerative colitis in some individuals. Three cases in the United States have gone to trial thus far, with all three resulting in multi-million dollar judgments against the makers of isotretinoin; there are an additional 425 cases pending.

Depression

Since the 1980s, scientific research has suggested a relationship between isotretinoin administration and the onset of psychological symptoms including depression, suicidal ideation, and psychosis. Several recent studies have shown a link between isotretinoin and clinical depression. However, there have also been studies arguing that there is no evidence of such a link. In a study in 2006, it was demonstrated for the first time that isotretinoin administration enhances depression-related behaviors in mice. Various case reports of depression, suicidal ideation, suicide attempt, and suicide in patients treated with isotretinoin have been reported to the U.S. FDA Adverse Events Reporting System, with 431 cases reported between 1982 and May 2001 – of these, 37 patients had committed suicide

Stunted growth in height

In FDA's medication guide for Accutane it says "Accutane may stop long bone growth in teenagers who are still growing". Several reports states that spontaneous premature epiphyseal closure can occur in acne patients receiving recommended doses of Accutane. Since the age until complete ossification of bones varies between individuals (17–20 years for upper limbs, 18–23 years for lower limbs) and since many are prescribed Accutane in their late teens, when growth still occurs but has begun deaccelerating, there is a risk for a gray zone with people being affected without knowledge about it. The effect of multiple courses of Accutane on epiphyseal closure is unknown.

Teratogenicity (birth defects)

Isotretinoin is a teratogen and is highly likely to cause birth defects if taken during pregnancy. A few of the more common birth defects that this drug can cause are hearing and visual impairment, missing or malformed earlobes, facial dysmorphism, and mental retardation. Isotretinoin is classified as FDA Pregnancy Category X and ADEC Category X, and use is contraindicated in pregnancy.
The manufacturer recommends that pregnancy be excluded in female patients two weeks prior to commencement of isotretinoin, and that they should use two simultaneous forms of effective contraception at least one month prior to commencement, during, and for at least one month following isotretinoin therapy.
In the U.S., more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion or miscarriage. About 160 babies with birth defects were born. As a consequence, the iPLEDGE program was introduced by the U.S. Food and Drug Administration on 12 August 2005 in an attempt to ensure that female patients receiving isotretinoin do not become pregnant. As of 1 March 2006, only prescribers registered and activated in iPLEDGE are able to prescribe isotretinoin, and only patients registered and qualified in iPLEDGE will be able to have isotretinoin dispensed. The iPLEDGE program also applies to males, even though there has been no evidence of isotretinoin excretion through seminal fluids.
Patients receiving isotretinoin therapy are not permitted to donate blood during and for at least one month after discontinuation of isotretinoin therapy due to its teratogenicity.