Use the FDA’s MedWatch for the Latest Drug Safety Information. If a medication you take requires additional warnings, you can learn about it on this web site of the U.S. Food and Drug Administration.

MedWatch is the FDA’s web site for reporting current medication safety information about drugs and medical products which are regulated by the U.S. Food and Drug Administration. The “What’s New” column on the left side of the home page is where the news is posted as it becomes available. You can subscribe to receive safety alerts by email.

On 10/24/2007 the FDA and Cephalon (manufacturer of Provigil) notified healthcare professionals of an updated WARNINGS section of the prescribing information for the drug. According to the posting,

“Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.”

Obviously, this is good information to know. Other than the specific side effects, it means Provigil is like any medication. One must balance the side effects (and potential side effects) against the good the medication does. The information about these additional side effects serve as a reminder than any chemical one uses to modify the way a brain works may hold unexpected dangers.

It’s good to know that should my wife suddenly experience any of these side effects, her Provigil may be the reason. Of course, these additional potential side effects are also listed in the prescribing information for a couple of her other medications, too. Modifying brain chemistry is a tricky thing.

Here’s what surprises me. I did not learn of the FDA’s updated warnings from a healthcare provider. Nor did my wife receive information about the updated warnings from a doctor, pharmacist or the drug manufacturer.

I first learned about the new prescription warnings by reading it on a financial news web site.  TheStreet.com posted an article on 10/24/07, by Elizabeth Trotta, titled “FDA Warns on Cephalon’s Provigil“.  The Multiple Sclerosis Foundation has a good article about this issue, too: “New Warnings for Provigil“.

Cephalon’s “Newsroom”, the page on their corporate web site for news releases, provides no mention of the updated warning (I’m exploring the Cephalon site on 11/04/07). Cephalon’s web site has a page of corporate information for investors, but nothing there is about the 10/24/07 FDA announcement of the updated prescription warning.

Cephalon also has a product-specific web site for Provigil at www.provigil.com. The Provigil.com web site offers a lot of good information about the medication and its uses. If you or someone you know takes Provigil, the Provigil.com web site is a great resource for you. The important information for patients about side effects and medication use is available from the upper right hand link, “Patient Information”. The information is dated August 2007 (before the FDA MedWatch notice).

The lesson for patients and caregivers? Use MedWatch AND the web sites of drug manufacturers to stay on top of important drug safety information.

How Drug Safety Information Seems to Flow

MedWatch is the official place to read the latest drug safety information. Generally, this seems to be how drug safety information flows: Drug safety news appears initially on MedWatch. Next, the news media (medical news and financial news) pick up on the MedWatch postings and write articles to inform the public of significant drug safety news. Then drug manufacturers and medical professionals inform patients.

However, in Cephalon’s case with Provigil, the drug manufacturer was ahead of the FDA MedWatch posting. The Provigil FDA Approved Labeling (PDA File) was updated on August 17, 2007 and on September 12, 2007, a “Dear Healthcare Provider” letter (PDF File) was produced which details the updated information and warnings.

Good job, Cephalon.

Caregiver Tip: Know the names of all the drugs taken by the MS patient for whom you care. Check MedWatch regularly to learn about drug safety news related to these medications. I’ve added a link to MedWatch in the right hand column. Also, visit the web sites of the drug makers for current information. As they say, “knowledge is power”.

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