Accutane Blog

What Is the FDA's Role in Approving Drugs?

2010-03-10T08:20:00.000-08:00

Before a drug can go into general distribution in the US, it must undergo a lengthy approval process through the Food and Drug Administration (FDA). This process involves several levels of testing for safety and effectiveness. Any risks are noted, and if the benefits of the drug significantly outweigh the risks, the drug is likely to be approved.

Levels of Testing
A new drug typically undergoes three years or more of testing in the laboratory before application is made to the FDA to begin the approval process. The FDA process can take as long as another eight years.

FDA testing uses three phases of clinical trials, each one involving a larger sample group to determine the drug's effectiveness:

Phase One-20-80 healthy volunteers, process takes about one year
Phase Two-100-300 patient volunteers, process takes about two years
Phase Three-1000-3000 patients, process takes about three years

After this testing is complete, the company developing the drug can submit an application to the FDA for approval. This process takes another two and a half years on average. The complete cost of the approval process averages $350 million.

The FDA uses this complex process to ensure drugs work as advertised, and that drugs that go on the market are accompanied by sufficient documentation of any possible risks or precautions.

In spite of the FDA's rigorous approval process, some drugs on the market still lead to serious and even deadly side effects. If you have suffered from serious side effects due to a prescription drug, please contact a pharmaceutical injury attorney in your area for more information about possible compensation.

What Does a Pharmaceutical Injury Attorney Do?

2010-02-09T08:19:00.000-08:00

Continued research and knowledge regarding treating various illnesses and conditions have led scientists to develop numerous medications for conditions that previously were very difficult or even impossible to treat. Unfortunately, some of these medications, even while effective, have proven to cause serious side effects. In these situations, a pharmaceutical injury attorney can help affected individuals get compensation for their injuries.

Class Action Suits
Many pharmaceutical injury lawsuits involve class action suits, in which a group of people is represented in a case rather than a single individual. Accutane is a dangerous acne drug that led to large class action lawsuits. Often, more than one person will experience the same injuries from a particular drug, and an attorney will pool information about the symptoms, causes, and other specifics in order to make a case.

If you need to contact a pharmaceutical injury attorney, it is important to know:

The type of drug and dosage you were taking
The exact side effects you experienced and their severity
Any medical attention you received for the side effects

This information will be helpful for your case as well as in compiling information to prove the drug is dangerous.

If you have suffered severe side effects from a drug prescribed by your doctor, you might need help from a qualified and experienced pharmaceutical injury attorney. Please contact an experienced attorney in your area today for more information about possible compensation.

What is a Pharmaceutical Litigation Attorney?

2010-01-08T08:18:00.000-08:00

In spite of the rigorous approval process employed by the Food and Drug Administration (FDA), some drugs certified as safe can still result in serious side effects. These side effects can lead to irreversible damage and even death. When people suffer injury or illness, or even lose a loved one due to dangerous drugs, a pharmaceutical litigation attorney can help them receive compensation for their injuries.

How to Find a Pharmaceutical Litigation Attorney
If you are in need of a pharmaceutical litigation attorney, be sure to do some research before making a decision. While many attorneys handle this kind of case, it is important to find someone who is not only familiar with the pharmaceutical litigation process, but who is also familiar with the drug which has caused your injuries. For example, if you have suffered serious side effects due to using Accutane to treat acne, a lawyer who is familiar with existing lawsuits involving Accutane will be much better equipped to help you make a case.

Filing a Pharmaceutical Injury Lawsuit
If you feel you might be entitled to compensation due to harmful side effects from a drug, it is important to keep track of certain information that will be useful to your pharmaceutical injury attorney. Be sure to make note of:

The type of drug you were taking
The dosage and quantity you were prescribed
The side effects you experienced
Whether you experienced side effects while taking the drug or shortly thereafter

This information could be vital in not only making a case for yourself, but in collecting information about dangerous side effects that could help those seeking compensation later, or for organizations who keep records of dangerous drug reactions.

If you have suffered severe side effects while taking Accutane or any other prescription medication, please contact a pharmaceutical injury attorney in your area today for more information about your rights and possible compensation.

The Dangers of Accutane

2009-12-20T12:07:00.000-08:00

While Accutane is very effective in treating severe acne, it also carries with it a host of dangerous side effects. Because of the drug's effectiveness, it was for a time prescribed for moderate as well as severe acne, leading to a wider occurrence of serious reactions to the drug.

Most Common Side Effects of Accutane
The most commonly occurring side effects linked to Accutane include:

Severe birth defects
Increased risk of sunburn
Depression, including thoughts of suicide
Inflammatory bowel disease

The occurrence of birth defects in unborn children is the most severe side effect of Accutane. These birth defects can be profound and even fatal. Because of this, Accutane is now only prescribed under very controlled circumstances. Women of childbearing potential who take Accutane must agree to use two forms of birth control, and must take a pregnancy test before beginning treatment.

Avoiding the Dangers of Accutane
In addition to diligent birth control, other precautions can help reduce the possibility of dangerous side effects. Avoiding sunlight or artificial ultraviolet rays, such as in a tanning bed, can help reduce the danger of severe sunburn. It is also important not to take vitamin A supplements or any supplements that include this vitamin. Since Accutane is a derivative of vitamin A, additional vitamin A can increase the risk of side effects.

If you have experienced severe side effects after taking Accutane, a pharmaceutical injury attorney can help. For more information about Accutane or other drugs, please contact an experienced pharmaceutical injury attorney in your area.

How is Accutane Dangerous?

2009-11-19T12:06:00.000-08:00

Accutane, a powerful anti-acne medication, has been linked to a number of severe side effects, including profound birth defects. Because of this, its use has been limited to treating severe acne that does not respond to any other treatment. Female patients of childbearing age must use birth control while using Accutane, and undergo pregnancy testing before beginning treatment.

Why is Accutane Dangerous?

Accutane is a derivative of vitamin A. Like many vitamins, vitamin A causes serious toxic reactions when taken in large quantities. The side effects of Accutane are similar to those of vitamin A toxicity.

In addition to birth defects, side effects linked to Accutane include:

Sensitivity to sunlight
Gastrointestinal problems, sometimes severe
Hair loss
Depression

While Accutane is intended for use only with severe acne, its effectiveness led doctors to prescribe it for moderate acne, as well, causing side effects to become more widespread. Accutane usage by women who could become pregnant was not as strictly controlled or monitored, either, so Accutane-related birth defects also became more common.

Accutane Lawsuits

The occurrence of severe side effects linked to Accutane has led to the drug's being carefully restricted. It has also led to the filing of several pharmaceutical injury suits against the drug's manufacturers. If you have suffered from side effects due to Accutane, you may need the assistance of a lawyer. For answers to any questions you may have about Accutane or other drugs, please contact a pharmaceutical injury attorney in your area as soon as possible.

What is Accutane and How is it Used?

2009-10-20T15:02:00.000-07:00

A powerful treatment for otherwise untreatable acne, Accutane is a vitamin A derivative that often eliminates serious acne after a single five- to six-week course of treatment. Unfortunately, Accutane has also been linked to severe side effects.

Prescribing Accutane

Accutane was developed to treat severe acne that does not respond to traditional treatments such as antibiotics and topical creams. However, due to its effectiveness, doctors began to prescribe it more often for less severe acne. This wider usage made side effects more common. Because the side effects can be so severe, a number of class action and pharmaceutical injury suits have been filed against the makers of Accutane.

Accutane Side Effects

The side effects of Accutane are similar to that of high vitamin A toxicity. The most severe of these affect unborn babies if their mothers use Accutane. Profound birth defects can result if Accutane is taken during pregnancy, including damage to the eyes, ears, face, and brain.

Other side effects linked to Accutane include:

Inflammatory bowel disease
Sensitivity to sunlight
Depression, including suicidal thoughts

The occurrence and severity of side effects are directly related to the dosage frequency and amounts, so the larger the dosage, the more likely side effects are to occur, and the more severe they are likely to be.

An experienced pharmaceutical injury attorney in your area can give you additional information about Accutane or any other prescription medications. For answers to your questions about pharmaceutical litigation, please contact a pharmaceutical injury attorney today.

What is Accutane?

2009-09-29T11:47:00.000-07:00

Acne is a common affliction during puberty and usually comes and goes without major side effects. However, some forms of acne, especially nodular acne, can leave behind severe scarring. Unfortunately, the usual treatments, including antibiotics, have little effect on this form of acne.

Accutane is a drug used specifically to treat severe cases of nodular acne that do not respond to antibiotics or other treatments. It is very effective, usually producing dramatic results in four to six months of treatment.

Side Effects of Accutane

A derivative of vitamin A, Accutane can cause severe side effects, much as vitamin A can if taken in very large doses. Most notably, Accutane has been shown to cause severe birth defects. Because of these known side effects, Accutane is strictly regulated, and female patients must use birth control while taking the drug.

Other serious side effects that have been linked to Accutane include:

Sensitivity to sunlight
Inflammatory bowel disease, including Crohn's and ulcerative colitis
Depression, including suicidal thoughts
Headache

Some side effects of Accutane can prove permanent, or lead to permanent problems. Because of the severe nature of these side effects, the FDA has placed strict warnings on the drug, and several class action and personal injury suits have been filed against the makers of Accutane.

If you have suffered severe side effects while taking Accutane or any other medication, please contact an experienced pharmaceutical injury attorney in your area for more information about possible compensation for your injuries.

Welcome

2009-02-10T09:06:00.000-08:00

Welcome