Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Thursday, September 13, 2007

Tysabri vs. Avonex, Betaseron, and Rebif (Interferon Beta)...Is your Interferon Beta therapy as safe as you really think it is???

Just take a look at what I found, and hold on to your chair because you might fall out of it!

From 1998-2005, the eight-year period covered, INTERFERON BETA was
ranked #8 on the list of "suspect drugs" causing death with a WHOPPING (to me, anyway) 1178 reported.

It also
ranked #4 in the list of suspect drugs causing death, disability or having other serious outcomes combined for a total of 9498 SAEs (Serious Adverse Events) reported.

Most Frequent Suspect Drugs in Death and Serious Nonfatal Outcomes, 1998-2005
Drug Name-Rank/Deaths-Drug Class Death: Most Frequent Suspect Drugs in Death
and Serious Nonfatal Outcomes, 1998-2005
Drug Name Rank/Deaths Drug Class
Death outcome
Oxycodone 1/5548 Opioid analgesic
Fentanyl 2/3545 Opioid analgesic
Clozapine 3/3277 Antipsychotic
Morphine 4/1616 Opioid analgesic
Acetaminophen 5/1393 Analgesic
Methadone 6/1258 Opioid analgesic
Infliximab 7/1228 DMARD
Interferon beta 8/1178 Immunomodulator
Risperidone 9/1093 Antipsychotic
Etanercept 10/1034 DMARD
Paclitaxel 11/1033 Antineoplastic
Acetaminophen-hydrocodone 12/1032 Combination analgesic
Olanzapine 13/1005 Antipsychotic
Rofecoxib 14/932 NSAID
Paroxetine 15/850 Antidepressant

Disability or other serious outcome:
Estrogens 1/11 514 Hormone
Insulin 2/9597 Hormone
Infliximab 3/8754 DMARD
Interferon beta 4/8320 Immunomodulator
Paroxetine 5/8095 Antidepressant
Rofecoxib 6/7766 NSAID
Warfarin 7/6250 Anticoagulant
Atorvastatin 8/6022 HMG-CoA reductase
Etanercept 9/5586 DMARD
Celecoxib 10/4822 NSAID
Phentermine 11/4607 Antiobesity
Clozapine 12/4388 Antipsychotic
Interferon alfa 13/4162 Immunomodulator
Simvastatin 14/3885 HMG-CoA reductase
Venlafaxine 15/3688 Antidepressant

(I will just list the SAEs #'s for Interferon Beta) Drugs With 500 or More Reported Deaths and Serious Adverse Drug Events in Any Year

Interferon beta . . . Combined Total 9498 ...'98-349, '99-392, '00-769, '01-777, '02-1032, '03-1240, '04-2210, '05-2729

As I sit here typing this, fully aware of the serious nature of PML (btw, there was no Natalizumab/TYSABRI mentioned in the article despite covering through 2005), I'm thinking, let's see, it's OK to market a class of drugs to treat MS (i.e.,
INTERFERON BETA) that has caused over 1000 deaths and over 8000 SAEs over an 8-year period, yet, we have a new drug for MS (i.e., TYSABRI) that's twice as effective as the aforementioned drug class, and we encounter only 2 cases of PML (1 fatality in a patient who's diagnosis of MS was suspect at the time of autopsy) that can't even be attributed to Tysabri in and of itself, and this constituted sufficient grounds for having that drug withdrawn from the market for 18 months, as well as restrictions being placed on its use when re-released??? And MS patients are afraid to take Tysabri? And neurologists are afraid to prescribe Tysabri?.

What's wrong with this picture?

Here is the
Moore et al., Archives of Internal Medicine, abstract below:

Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD

Arch Intern Med. 2007;167:1752-1759.


Background The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers.

Methods Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug Administration from 1998 through 2005.

Results From 1998 through 2005, reported serious adverse drug events increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%).

Conclusions These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.

I do hope that MS patients will fully arm themselves with this information if they are on either Avonex, Betaseron, or Rebif and are afraid of Tysabri... the numbers speak for themselves.

Love, Lauren
A very proud member of


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