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Accutane Side Effects | Legal Information
Accutane Lawyer
 Central Nervous System: Pseudotumor Cerebri
Benign Intracranial Hypertension, Intracranial Hypertension
Accutane has been associated with pseudotumor cerebri!
Under Federal Law, the manufacturer of a drug is required to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.
The FDA has required Hoffmann-La Roche to change their label for Accutane many times. The most recent label states - Pseudotumor Cerebri: Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue Accutane immediately and be referred to a neurologist for further diagnosis and care.
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on a voluntary basis. In other words, the doctor, hospital, or other medical person or facility are not required by law to report an adverse side effect from a drug. The FDA reported that perhaps only one in one hundred side effects ever get reported. One could only imagine about how many serious Adverse Side Effects there are from taking Accutane, that have never been reported to anyone!
About Pseudotumor Cerebri
What is Pseudotumor Cerebri?
Pseudotumor cerebri, also called benign intracranial hypertension, literally means "false brain tumor." It is caused by increased pressure within the brain and is most common in women between the ages of 20 and 50. Symptoms of pseudotumor cerebri, which include headache, nausea, vomiting, and pulsating intracranial noises, closely mimic symptoms of brain tumors, possibly because of the abnormal buildup of pressure within the brain.
What causes Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)?
There are many reasons why a person can have elevated cerebrospinal fluid pressure (brain mass, medications, infections, etc.). These possible causes for elevated cerebrospinal fluid pressure must be excluded prior to diagnosing benign intracranial hypertension. The cause of the elevation of cerebrospinal fluid pressure in pseudotumor cerebri is not known. Accutane has been associated with pseudotumor cerebri.
What are the common signs and symptoms of Pseudotumor Cerebri?
Most patients with pseudotumor cerebri experience headaches. The headaches may be aggravated by changes in position. There may be a ringing or a "whooshing" sound in the ear. A patient may experience double vision.
In this disorder, it is common to have momentary loss of vision known as "transient obscuration of vision". Other visual symptoms are a central blind spot, blurred vision, or loss of peripheral vision in one or both eyes. The visual loss may be mild to severe. If severe and untreated, it can result in blindness. The optic nerves are usually swollen in appearance.
Is there any treatment?
Treatment for pseudotumor cerebri is generally symptomatic. Pressure may be controlled by removing excess fluid with repeated spinal taps or by shunting. Steroids may be prescribed to reduce swelling of brain tissue. Drugs to reduce cerebrospinal fluid production or hyperosmotic drugs may be used to reduce fluid buildup.
What is the prognosis?
Once the diagnosis is made and the disorder is treated, pseudotumor cerebri generally has no serious consequences. If visual loss occurs, however, it may be permanent regardless of treatment. In some cases, pseudotumor cerebri recurs.
For additional information visit www.accessible.ninds.nih.gov, or contact the following organizations:
FDA - Accutane Information Page
Intracranial Hypertension Research Foundation
6517 Buena Vista Drive
Vancouver, Washington 98661
Info@ihrfoundation.org
www.IHRFoundation.org
National Organization for Rare Disorders (NORD)
Post Office Box 1968
(55 Kenosia Avenue)
Danbury, Connecticut 06813-1968
orphan@rarediseases.org
www.rarediseases.org
Pseudotumor Cerebri Society
750 East Adams Street
c/o Dr. D. Friedman
Syracuse, New York 13210
Telephone: (315) 464-3937
Fax: (315) 464-5006
Pseudotumor Cerebri Support Network
8247 Riverside Drive
Powell, Ohio 43065
sondra@sprynet.com
www.pseudotumorcerebri.com
 If you believe you have been injured or have suffered a severe side effect from the use of Accutane, it may be that you are entitled to compensation.
It is important that if you contact our firm for a free case evaluation. Our lawyers will analyze your case and advise whether you are entitled to compensation. Contact us here
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