Archive for the ‘MS Medications’ Category.

MS Drug Causing Liver Damage

February 28, 2008, 6:32 am

MSNBC.com has a piece this morning about the Multiple Sclerosis drug Tysabri® (natalizumab). The drugmakers have issued warnings to doctors because Tysabri is causing significant liver damage to some patients who take it. In some patients the damage occurred as early as six days after beginning the treatment.

MSNBC.com : Multiple sclerosis drug linked to liver injury

Information about this new warning is available from the FDA web site, too:

Read the revisions to the Warnings and Precautions section of the full Prescribing Information:

http://www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf

(Notice, too, I’ve added a link to the Food and Drug Administration’s web site to the “MS Resource Sites”. The FDA is at: http://www.fda.gov)

The liver is an incredible organ which often goes unappreciated. Because it cleans the blood, anything in the bloodstream can impact the health of the liver. MedicineNet.com has a good article titled, “Drug-Induced Liver Disease” by Dennis Lee, MD. If you care for an MS patient, this article should be required reading.

Caregiver Tip: Whether the person you care for takes Tysabri or other medications, read “Drug-Induced Liver Disease” and pay attention to signs and symptoms of liver damage.

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Category: MS Medications  |  Comment

Check the Meds

February 5, 2008, 10:35 pm

When you pick up medications from the pharmacy, the drugs look so nice and clean.  Certainly, medications must be manufactured with the most stringent quality controls to ensure purity.  That’s probably why they’re so expensive. Right?  And if you’re like me, the high cost of medications does have the small positive effect of helping you feel good that you have access to such high quality substances.

Well, according to an Associated Press article released today, Tainted Pills Hit U.S. Mainland.  The article reports 13 of the 20 best-selling drugs in the US come from Puerto Rico and quality control measures are lax.

Is this article reason to be overly concerned or avoid taking medications?  No.  It should only serve as a reminder to inspect medications before they are taken.

Apparently, poor quality control has been an industry concern for years, yet industry professionals report the tainted medications are safe and effective.

Caregiver’s Tip: Always check the appearance of medications when they are administered. Know what the medications should look like. For example, clear liquids should be clear. Pills should not be contaminated with foreign material, paint flecks or other particles. Any medication that looks odd should be returned to your pharmacist.

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Category: MS Medications  |  Comment

MS Medications: Questions I Ponder

January 29, 2008, 10:38 pm

While the benefits of early and long-term MS therapy have been documented, there are questions about MS medication I can’t help but ask.

First, why are the costs for the 4 MS therapies so similar?

I’ve just checked the prices on Drugstore.com for a typical one-month supply of each of the four MS “therapies”. Here is what I found on January 29, 2008 (in alphabetical order):

Avonex (Four 30mcg/0.5ml Syringes) $1,720.99
Betaseron (15 vials 0.3mg Solution) $1,699.99
Copaxone (1 box of 30 prefilled syringes $1,886.89
Rebif (6 ml, 44mcg/0.5ml Solution) $1,893.62

These four medications were developed at different times, by different companies, and are manufactured differently. The difference in prices between the most expensive and the least expensive is only $193.63 per month. That amount may seem large, but it represents a price spread of only 10.2% of the cost of the most expensive, Rebif.

Also, where can one find a list of neurologists who have never benefited financially from an association with one of these companies?

I ponder this because of an article I read last night in the Wall Street Journal HealthBlog which quoted two MDs who are dismissive of one of the newer MS “therapies”. However, readers of the blog left comments indicating they believe the two docs may benefit from their relationships with another MS therapy manufacturer and, thus, their opinion may be tainted.

I’d like a list of doctors who haven’t been influenced, lobbied, etc.  It seems like a list a doctor would be proud to sign.

Here’s one that really makes me wonder. If the average time between exacerbations in Relapsing Remitting MS is two years, why does it seem many of drug studies I’ve read on Avonex, Betaseron, Copaxone and Rebif are limited to two years? I can’t help but wonder if this is by design so the studies are not negatively impacted by participants who cross the two year average and increase their chances of an exacerbation, thus ruining the desired outcome of the study.

And where can I find a study that compares all four of these medications against each other. I have found studies of each against a placebo (and some make placebos look pretty good … they have fewer side effects), but I can find no single study that compares Avonex against Betaseron against Copaxone against Rebif against a placebo.

So help me! If you can answer my questions or provide links to studies that can, please leave a message in the comments. I’d love to find the answers.

Caregiver Tip: Always ask questions.

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Category: MS Medications  |  1 Comment

Drug Safety Information: Stay on Top of It

November 4, 2007, 12:33 pm

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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