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Meda Pharmaceuticals
MEDA PHARMACEUTICALS INC. PRIVACY POLICY


Introduction
Thank you for your interest in MEDA Pharmaceuticals Inc. We invite you to explore our websites and learn more about us and our products. As you do so, you should know that we respect your privacy and are committed to protecting the personal information that you share with us. This Privacy Policy summarizes our standards for collecting, using, storing and sharing the personal information that we, or companies that work with us, obtain from our websites, e-mail or other Web-based tools.

MEDA Pharmaceuticals Inc. is the United States subsidiary of MEDA AB, a global specialty pharmaceutical company based in Sweden and doing business in more than 41 countries around the world. This Privacy Policy applies only to MEDA Pharmaceuticals Inc., and to the MEDA product websites specifically identified as intended for use only by residents of the United States and its territories. Our Privacy Policy applies to the information that we or our trusted business partners collect from our online resources and communications like e-mail, websites, online ordering tools and other similar content. Our Privacy Policy does not apply to third party online resources, even if our website offers courtesy links to them. We do not control the content or the privacy practices of third party resources. Read the Privacy Policy of any website or other online resource that you visit to make sure that you understand and agree with it. (That applies to our Privacy Policy too - we want you to read it carefully). If you have questions about it, or about how we protect the privacy of your personal information, you may contact us at privacy@meda.us.

We reserve the right to update or change this Privacy Policy and so, we may do that from time to time. If we do, you will be able to find those changes here. We also will tell you when the Privacy Policy was last updated or revised. This Privacy Policy was last updated on March 31, 2009.

What is - and is not - personal information? What is meant by "de-identified" information and "aggregated" information?

When we use the term "personal information", we are referring to information that can be readily used to identify a specific living person. Examples of personal information that we might wish to collect from you might include your name and your street or e-mail address. All of those items of information can be used to identify you.

Information that relates to you, but cannot be used to identify you, is not "personal information." So, for example, your state of residence is a piece of information about you, but it is not, by itself, "personal information." However, if we collect your street address and your state of residence and we put them together in our systems, we would treat both pieces of information as "personal information" because, when taken together, they can be used to identify you.

De-identified information is information that has been stripped of features that would permit the identification of a specific living person. When de-identified information about multiple people is put together, it is referred to as "aggregated" and de-identified information. Sometimes, MEDA may choose to aggregate personal information obtained from individuals through a variety of different channels. When we do, we seek to do that in a manner consistent with this Privacy Policy and any other privacy notices that we may have provided to you.

Why does MEDA collect personal information?

We collect personal information to improve your experience as a user of our websites and also to improve others' experience as well. Sometimes the personal information that we collect enables you to use online resources or obtain communications about topics of interest to you. Personal information collected online also can help us improve our products and services, or design other features and resources that individuals would like to see us offer. We analyze the personal information that we collect so that we can identify and offer new products and services.

How do we collect personal information?

We collect personal information online through websites and other sponsored resources. Sometimes, we work with other companies that collect personal information at our request. When we work with another company, our work together is regulated by an agreement that, among other things, requires that company to properly protect the personal information it collects for us.

What tools does MEDA use to collect personal information?

Tools used from time to time to collect personal information include:
Direct Collection. In other words, we collect personal information from you by asking you to fill in an online form or participate in an interactive display. Contact details - your name, street address, e-mail address, telephone number, birth date, etc. - are often collected directly. So is health status, so that we can provide you with information that is more likely to be relevant to you.

"Cookies". Sometimes we use cookies, and so do some of the advertisers that place advertisements on our websites. A "cookie" is a data file that a website may place on your computer hard drive. In general, cookies are used to simplify and improve your communication and interaction with a website. A website sponsor's ability to use a cookie to retrieve information from your computer can help customize the presentation of products and services, or help the website sponsor enhance their service to you.

Some cookies are temporary and erased when you leave the Internet or shut down; others stay on your computer unless or until you remove them. If you do not wish to receive cookies from MEDA websites, you can adjust your Web browser preferences on your computer. You can still visit our websites if you refuse cookies; but you may find that some of the features do not work, or do not work as well.

As a matter of policy, MEDA does not use cookies to retrieve information from your computer unless the information is related to our website or your interaction with our website.

Web Beacons. These are tiny graphics that are similar to cookies. They collect information that cannot be used to identify you personally, like the addresses of websites that you view, the website that you visited just before you came to our website, or the link that you clicked on to reach our website. Sometimes Web Beacons are used to monitor whether certain email messages are opened.

Clickstream Data. As you use the Internet, a "trail" of electronic information is left at each website you visit. This information is sometimes called "clickstream data", and it can be collected and stored by a website's server. Clickstream data is not "personal information" - it cannot be used to identify you. However, it can provide information about the type of computer and browsing software that you use, and it can identify the address of the website link that you used to reach our website. Clickstream data can be "aggregated" or combined with clickstream data from other people to anonymously determine how much time visitors spend on each page of our websites and how visitors navigate through our websites. Having this information and sharing it with business partners and advertisers can help us tailor our websites to better meet visitors' needs.


Does MEDA collect personal information from children?

In general, our websites are not directed at children and most of the online services that we offer are designed for adults, age 18 or older. Where requests for information about a medication are permitted by law, people requesting information about a medicine that is indicated for use in children must be 18 years old or older.

How does MEDA ensure that the information that we have about you is correct? Can you correct it?

Where offered, you may also update personal information about you online by modifying information that you previously entered into a Web form or data fields on our website. Otherwise, to gain access to personal information about you that we have collected online, and to keep it accurate, complete and current, you may contact us at privacy@meda.us. You may not always be able to access the information that has been collected; where permitted by law, your ability to access and correct personal information will be limited where we believe it would interfere with our ability to fulfill legal or ethical obligations or address legal claims. Access and correction also will not be allowed if it would result in disclosure of a third party's personal information, or lead to a breach of contract or disclosure of trade secrets or other protected business information.

How does MEDA store and secure personal information?

We strive to protect personal information as it is transmitted from your computer to our online resources and servers. Due to the open nature of the Internet, we cannot guarantee that our interactions with you, and yours with us, will be free from unauthorized access by third parties. We protect our servers and data with a firewall and endeavor to protect personal information in our possession, custody or control from unauthorized access, disclosure, alteration or destruction. Employees and business partners with access to your personal information must have a business-related "need to know" in order to perform their job functions for us. However, we also depend on you to help secure your information by protecting your own copies of passwords and related access codes for our online resources.

Who has access to your personal information?

Personal information about you is accessible to MEDA, including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use personal information solely for and at the direction of MEDA. Uses and disclosures of personal information by external individuals and organizations acting on MEDA's behalf are governed by agreements that require personal information to be protected appropriately. Personal information about you only will be used and disclosed by MEDA and individuals and organizations working on its behalf, in a manner consistent with this Privacy Policy, other applicable privacy notices, and as explicitly permitted or required by applicable laws, rules and regulations.

Does MEDA share your personal information with third parties?

In general, MEDA does not sell or barter your personal information to third parties. However, if MEDA decides to reorganize or divest its business through sale, merger or acquisition, it is possible that personal information may be shared with actual or prospective buyers. If that happens, MEDA will obtain a written agreement that personal information will be properly protected. Except where explicitly permitted or required by law, or provided in this Privacy Policy, personal information will not otherwise be shared without your consent.

Can you choose whether and when to share personal information with MEDA?

You do have some choices about whether and when to share personal information with MEDA.
  • If you do not want to provide any personal information to MEDA online, you can decline to enter personal information into forms or data fields on websites. You can also refuse to use personalized services offered by online resources. However, you do need to bear in mind that some online resources are only available to people who do choose to provide their personal information.

  • If you do provide some personal information online, some MEDA online resources may ask you if we can use and disclose your personal information to add you to contact lists, and to identify other services and promotions of possible interest. You can manage proposed additional uses of personal information about you by giving or withholding permission (e.g., by "checking" or "un-checking" boxes or "radio buttons" on Web forms). Also, you can change your communication preferences. For example, if you no longer wish to receive a communication, you can contact us at info@meda.us.

  • MEDA online resources use tracking technologies like cookies to remember your personal preferences and selections. Tell us if you want us to use these tools to 'remember' you and give you more services by "checking" or "un-checking" options or "radio buttons" on our Web forms, or responding to survey questions appropriately. Please note that we cannot selectively "turn on" or "turn off" certain tracking technologies like "cookies" to accommodate individual user preferences. Depending on the Web browser you use, you may be able to control the use of certain tracking technologies by adjusting your browser settings. Remember: certain features on our websites and certain online resources may work better with cookies active or enabled, so you may lose some functionality if you turn off cookies and tracking technologies.

  • If you would like to opt-out of cookies placed by business partners that deliver e-mail communications for us, or place advertisements for us on other websites, please follow instructions provided by the Network Advertising Initiative at http://www.networkadvertising.org/optout_nonppii.asp
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Indication
  • FELBATOL (felbamate) should not be used as initial therapy in epilepsy (see Warnings in full Prescribing Information).
  • FELBATOL is recommended for use only in those patients who do not respond well to other treatments and whose epilepsy is so severe that the potential risk of developing aplastic anemia (a severe blood disorder) or liver failure is outweighed by the potential benefit of felbamate treatment.
  • After the patient or their caregiver has discussed the potential risks of Felbatol treatment with their doctor and have provided written consent, FELBATOL treatment can be considered. FELBATOL, by itself or in combination with other drugs is approved for the treatment of partial seizures, with or without generalization, in adults with epilepsy, and as combination therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Important Risk Information
  • FELBATOL should not be used in patients with a history of any blood or liver problems.
  • Routine blood tests should be performed that can help identify potential blood or liver problems.
  • FELBATOL should be discontinued if there is evidence that blood or liver problems have occurred.
  • Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • The most common adverse experiences observed in clinical studies are loss of appetite, vomiting, insomnia, nausea, headache, and sleepiness.
Please see the full Prescribing Information for additional safety information.


WARNING
1. APLASTIC ANEMIA THE USE OF FELBATOL® (felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBATOL® SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBATOL® WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.
AMONG FELBATOL® TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST.
THERE ARE TOO FEW FELBATOL® ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME’S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK.
IN MANAGING PATIENTS ON FELBATOL®, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBATOL® FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBATOL® EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBATOL® REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS.
IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBATOL® WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK.
IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBATOL® AFFECTS THE INCIDENCE OF APLASTIC ANEMIA. IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF INFECTION, BLEEDING, OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT, IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBATOL® SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS. 		2. HEPATIC FAILURE
EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF FELBATOL®. THE REPORTED RATE IN THE U.S. HAS BEEN ABOUT 6 CASES OF LIVER FAILURE LEADING TO DEATH OR TRANSPLANT PER 75,000 PATIENT YEARS OF USE. THIS RATE IS AN UNDERESTIMATE BECAUSE OF UNDER REPORTING, AND THE TRUE RATE COULD BE CONSIDERABLY GREATER THAN THIS. FOR EXAMPLE, IF THE REPORTING RATE IS 10%, THE TRUE RATE WOULD BE ONE CASE PER 1,250 PATIENT YEARS OF USE. OF THE CASES REPORTED, ABOUT 67% RESULTED IN DEATH OR LIVER TRANSPLANTATION, USUALLY WITHIN 5 WEEKS OF THE ONSET OF SIGNS AND SYMPTOMS OF LIVER FAILURE. THE EARLIEST ONSET OF SEVERE HEPATIC DYSFUNCTION FOLLOWED SUBSEQUENTLY BY LIVER FAILURE WAS 3 WEEKS AFTER INITIATION OF FELBATOL®. ALTHOUGH SOME REPORTS DESCRIBED DARK URINE AND NONSPECIFIC PRODROMAL SYMPTOMS (E.G., ANOREXIA, MALAISE, AND GASTROINTESTINAL SYMPTOMS), IN OTHER REPORTS IT WAS NOT CLEAR IF ANY PRODROMAL SYMPTOMS PRECEDED THE ONSET OF JAUNDICE. IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING HEPATIC FAILURE CHANGES WITH DURATION OF EXPOSURE.
IT IS NOT KNOWN WHETHER OR NOT THE DOSAGE OF FELBATOL® AFFECTS THE INCIDENCE OF HEPATIC FAILURE. IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECT THE INCIDENCE OF HEPATIC FAILURE.
FELBATOL® SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION. TREATMENT WITH FELBATOL® SHOULD BE INITIATED ONLY IN INDIVIDUALS WITHOUT ACTIVE LIVER DISEASE AND WITH NORMAL BASELINE SERUM TRANSAMINASES. IT HAS NOT BEEN PROVED THAT PERIODIC SERUM TRANSAMINASE TESTING WILL PREVENT SERIOUS INJURY BUT IT IS GENERALLY BELIEVED THAT EARLY DETECTION OF DRUG-INDUCED HEPATIC INJURY ALONG WITH IMMEDIATE WITHDRAWAL OF THE SUSPECT DRUG ENHANCES THE LIKELIHOOD FOR RECOVERY. THERE IS NO INFORMATION AVAILABLE THAT DOCUMENTS HOW RAPIDLY PATIENTS CAN PROGRESS FROM NORMAL LIVER FUNCTION TO LIVER FAILURE, BUT OTHER DRUGS KNOWN TO BE HEPATOTOXINS CAN CAUSE LIVER FAILURE RAPIDLY (E.G., FROM NORMAL ENZYMES TO LIVER FAILURE IN 2-4 WEEKS). ACCORDINGLY, MONITORING OF SERUM TRANSAMINASE LEVELS (AST AND ALT) IS RECOMMENDED AT BASELINE AND PERIODICALLY THEREAFTER. WHILE THE MORE FREQUENT THE MONITORING THE GREATER THE CHANCES OF EARLY DETECTION, THE PRECISE SCHEDULE FOR MONITORING IS A MATTER OF CLINICAL JUDGEMENT. FELBATOL® SHOULD BE DISCONTINUED IF EITHER SERUM AST OR SERUM ALT LEVELS BECOME INCREASED = 2 TIMES THE UPPER LIMIT OF NORMAL, OR IF CLINICAL SIGNS AND SYMPTOMS SUGGEST LIVER FAILURE (SEE PRECAUTIONS). PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON FELBATOL® AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR LIVER INJURY IF FELBATOL® IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT BE CONSIDERED FOR RETREATMENT.