What's the problem?

The Food and Drug Administration (FDA), which regulates the production and sale of prescription medicines in the United States, has not approved Frisium (clobazam). This means that if you live in the United States, you cannot get it from your drugstore in the same way that you get most other seizure medicines. (It is available in many other countries, including Canada, Australia, and the UK.)

Frisium belongs to the class of medications called benzodiazepines. Ativan (lorazepam) and Tranxene (chlorazepate) are other well-known benzodiazepines that are often prescribed for treating seizures. They have been approved by the FDA for sale in the United States. Your doctor will almost certainly recommend that you try medicines like these before trying Frisium, and one or more of them are likely to work well for you.

Frisium has a subtle chemical difference from these medications, however, and some people who have a problem with drowsiness when taking them find that they feel better if they take Frisium. If you have had trouble staying alert while taking the benzodiazepines that your doctor has prescribed, you may want to ask about trying Frisium. A reduction in the problem of tolerance also has been reported.

How can I get it?

Ask your neurologist to help you. The doctor's office can fax a prescription to the overseas pharmacy that you wish to use. You will need to provide your credit card number to the pharmacy and authorize the shipment of the Frisium to your home address.

When the time comes to reorder, be sure to begin the process well in advance so you won't run out of pills if the medication is delayed at the border. Sometimes the doctor may need to write a "letter of medical necessity" before it will be released to you.

Am I breaking the law if I buy Frisium?

In general, it is not legal to bring into the United States any medicine that has not been approved by the FDA. Customs officers are allowed to seize such products at the border, whether they are arriving by mail or are being carried by an individual.

The FDA recognizes, however, that there is not an effective FDA-approved treatment for every serious condition, so people who live in the United States sometimes may want to use medications from other countries. To make this possible, the FDA allows discretion in enforcing the law against importing foreign medicines such as Frisium. The medicine may be permitted to enter the country if several conditions are met:

• The product will be used to treat a serious disorder.
• The product is considered not to present an unreasonable risk.
• The quantity is reasonable for personal use, usually not more than a 3-month supply.
• The product will be used under medical supervision. A prescription from a physician licensed in the United States would be evidence to satisfy this requirement.
• The product is not commercially promoted in the United States.

What about cost?

Medical insurance in the United States generally does not pay the cost of medications purchased outside the country, so you will need to pay for the Frisium yourself. It is less expensive than many other seizure medicines, however. In early 2004, the cost of 50 tablets (10-mg) of brand-name Frisium was $30 at an online pharmacy overseas.

Thirty tablets of clobazam under the brand name Novo-Clobazam cost $18.08 at a Canadian online pharmacy, but you would need a prescription from a doctor in Canada so this is probably not a practical option for most Americans. Canadian pharmacies will not ship non-FDA-approved medications (or any type of benzodiazepine) to the United States. Similarly, Frisium was even cheaper in Australia (100 10-mg tablets for $19.90), but it cannot be shipped out of Australia.

Following the FDA's guidelines, the order will probably be for a 3-month supply, although larger amounts may be permitted. Common dosages are 2 or 3 tablets per day, so a 3-month supply may cost several times the 100-tablet price.