Serious Side Effects Associated with Accutane

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Serious Side Effects Associated with Accutane

Since 1982, a division of Hoffmann-La Roche, Inc. has manufactured Accutane in the United States. It is used to treat serious forms of cystic acne. Hoffmann-La Roche Inc. is the prescription drug unit of the Roche Group, one of the worlds leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics.

Accutane is a highly effective oral medication used to treat severe recalcitrant nodular acne that has not been helped by other treatments, including antibiotics. 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.

Accutane, and its generics, contain Isotretinoin. People who suffer from the embarrassments associated with acne need to be aware that Accutane carries a significant risk of adverse side effects in certain patients.

Health complications and the legal issues surrounding those caused by Accutane involve the use by pregnant women and associated birth defects and the use by teenagers and associated depression and suicidal behavior. According to the Food and Drug Administration (FDA), women who are pregnant or who might become pregnant and women who are breastfeeding SHOULD NOT take the drug.

Over the past two decades, Accutane has been linked to a large number of dangerous, even life threatening, side effects including:

* Birth Injuries and Birth Defects

* Depression and Suicidal Tendencies

* Psychiatric Diseases

* Central Nervous System Ailments

* Liver Disease

* Inflammatory Bowel Disease

* Hearing and Vision Problems

* Bone and Muscle Damage

* Pancreatic Damage

As with most prescription drugs, the side effects and severity of complications associated with Accutane vary from patient to patient and from case to case. Not every fetus exposed to Accutane has resulted in a deformed child, however, there is an extremely high risk that a deformed infant may result if pregnancy occurs and the woman has/had been taking Accutane even for very short periods. In addition, there is an increased risk of spontaneous abortion, and there have been reports of premature births associated with the use of Accutane. There have also been reported cases of IQs lower than 85 in some infants.

Similarly, not every teenager or young adult who takes Accutane will experience depression or suicidal thoughts. However, the potential for these side effects has caused enough concern, and are serious enough, that the risks must be addressed and taken very seriously.

Steps have been taken to help prevent Accutane’s potentially dangerous and undesirable side effects. Since the introduction of Accutane, education has played a large part in reducing and preventing the drugs’ fetal risks by reinforcing the importance of pregnancy prevention by women using the drug.

Prevention has not stopped at educating patients. Frequent updates and information on potential side effects of the drug are provided to doctors and other health care professionals. This includes notification to doctors that Accutane may cause depression and/or psychosis, as well as suicide, in some cases. This is to help ensure that health care providers make educated and ethical decisions based on the patients’ history and personal needs. Doctors have also been advised to monitor patients very closely for symptoms of depression.

All prescription drugs come with educational material included in the packaging. Accutane’s packaging advises patients to watch for signs of depression, such as feelings of sadness, irritability, fatigue, loss of appetite, trouble concentrating, thoughts of hurting oneself or suicidal thoughts. Unfortunately, many patients who take Accutane due not consider the possible side effects, as their desire for clear skin and their need to regain a positive self-image takes precedence.

Due to the number of potential complications associated with Accutane and the severity of the side effects, the FDA now requires any potential user to sign a consent form. Additionally, pharmacists must give users a detailed warning brochure from the FDA called a Medguide (Medication Guide). Only three drugs in United States history have been required the use of a Medguide: Accutane, Thalidomide and Mifeprex.

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Accutane And Its Long Term Effects

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Accutane And Its Long Term Effects

Acne is a common skin disease in America. Statistics say that about 60 million Americans have active acne. About 20 million Americans have scars on their face that are caused by the many avatars of acne such as blackheads, whiteheads, nodular acne and cystic acne. Yet, 40% of Americans that have acne do not do anything about the problem.

Accutane (manufactured by Roche) is the brand name of one of the retinoid class of drugs that is used for the treatment of acne. Its principal ingredient is isotretinion, a naturally occurring derivative of Vitamin A. Before this medication was developed, administering antibiotics (like tetracycline and minocycline) was the most commonly used method to treat acne. Gradually, the bacteria in the acne developed resistance to these antibiotics and their efficiency diminished with time, especially while dealing with serious acne conditions.

In cases where antibiotics proved ineffective, doctors administered high doses of fat-soluble Vitamin A, which worked better than the antibiotics. But this type of treatment had many negative side effects and, hence, did not gain popularity.

In the year 1982, Roche released a powerful acne drug by the name Accutane, the principal ingredient of which was a derivative of Vitamin A (isotretinion). It worked better than fat-soluble Vitamin A, had fewer side effects, and was declared an instant success. It continues to be a popular drug even today. However, like any other drug, there are some short-term and some long-term side effects associated with the drug.

Typically, a person suffering from acne is initially administered with topical medicines such as adapalene and/or oral antibiotics. If these initial medications do not show the desired results, only then is isotretinion prescribed. This is because, firstly, it is more expensive compared to other medications, and, secondly, its short-term as well as long-term effects are more adverse.

Accutane is an FDA-approved drug that is not available without a doctor’s prescription. It clears severe cystic acne in about 60% of cases when taken for 15 to 20 weeks.

Side Effects:

- One of the most serious side effects of Accutane is on a fetus. Under no circumstances should a woman get pregnant while taking this treatment. Or if already pregnant, treatment with this drug must not be started.

- Dryness of lips, mouth, nasal vents, eyes and skin. These effects are not so serious and can be managed with some effort. For example, the dryness of lips and the nose can be relieved with lubricants. Sucking on sugarless hard candy or ice chips, chewing sugarless gum, drinking water, or using a saliva substitute can relieve the dryness of the mouth.

- One major issue associated with the long-term use of isotretinion is that the skin becomes vulnerable. The probability of scarring is high for any cosmetic procedure such as hair removal, laser treatment and other skin resurfacing procedures. People who are going in for a skin or hair treatment while on this drug need to inform about the same to their doctor.

- Long-term use of isotretinion has been found to be related to decreased bone mass and tenderness of bones.

- Temporary thinning of the scalp hair is another observed side effect.

- Muscle and joint pain has also been noted in a long-term study on the drug.

Some patients may also experience short-term side effects such as headaches, depression, hearing loss, ringing in the ears, stomach pain, changes in blood pressure, elevated cholesterol and triglyceride levels, elevated liver enzymes, or a drop in the white blood cell count.

This acne treatment may also interfere or react with other medications and, therefore, you must always consult your doctor about drug interaction if you are taking this drug.

You will also need to make some adjustments in your lifestyle. Women must take care not to get pregnant, alcohol intake must be regulated, and the skin must be protected with an effective sunblock lotion every time you step out in the sun.

To sum up, this treatment in its oral form is an effective drug for treating acne and safe when taken under a physician’s care. In fact, some patients may not experience any serious side effects. Even in spite of the risks, this remedy should be looked upon in a positive light.

Doesn’t every drug have some kind of undesirable effects? Acne, if left untreated, has the potential to scar the face permanently and turn the acne-infected person into a socially unacceptable washout. So, if necessary, Accutane should be considered in order to get rid of acne, but always under medical supervision.