FDA Warning: Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death!!

I received this warning via email today and felt obliged to pass it on. I've never heard of Tygacil, but it is an IV drug used to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI)*, and community-acquired bacterial pneumonia (CABP), so I think this is an appropriate venue to share it.

"FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses." (from Drugs.com -- Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death)

The increased risk of death is only 0.7% compared to other antibiotics, but is still significant enough to be added to package warnings, and I expect most people would prefer to have this drug used when there are no other options left.

Be well my friends!

*Refer to the "Introduction" section of this article to get a better understanding of cIAI (from the World Journal of Emergency Surgery)

My November '11 Appointment with the Immunologist

I saw my Immunologist yesterday, and I was able to put my mind at ease over some of my concerns regarding stopping my infusions. I have been worried that I had no antibodies to the kinds of diseases that children get immunized for, and my immunologist showed me my most recent test results (2 months after stopping infusions),  and said that I have antibodies to those diseases. The part that I'm lacking is in defense against pneumonia-causing organisms like mycoplasma and other nasty things like that. He said that it's actually pretty common for CVID patients to have antibodies to most other diseases and just be lacking in defense against pneumonia. That really puts my mind at ease.

The one thing I forgot to ask him about is my hair falling out. I am a woman with long straight hair, and I wash it, condition it, and comb it. Lately it's been falling out by handfuls. I'm getting concerned and don't know whether it's CVID related. However, there are quite a few people in my support group who have the same issue.

I have now been off of my infusions for 6 months and off of Trileptal for 4 months, so yesterday they did some bloodwork to determine whether my antibodies are recovering now that I'm off of the Trileptal. I should know the answer in a few weeks! It would be so amazing and wonderful if I could recover and not have CVID. Of course, I may still be IgA deficient after this, but that would still be better than full-blown CVID!

On the downside, I'm on my 3rd round of antibiotics (in addition to the prophylactic ones) to kick what I believe is pneumonia. Originally I was sick for 4 or 5 days and seemed to recover on my own. I thought it was a good sign. Then about a week later I realized that I had not only a sinus infection but that it was moving into my lungs. I called for antibiotics, and they told me to take triple my normal dosage for 4-5 days then call to let them know how I was doing. I called on the specified day, and since I seemed to be feeling better and hadn't heard from them, I dropped back down to my maintenance dose the next day. That night I went to bed early and woke up about 9:00 PM with significant chest congestion. I made myself some hot lemonade to help loosen my chest up, and went back to bed. When I woke up the next morning I was so sick and so weak that I had difficulty walking just the few feet to my bathroom. I called the Dr back and they said to take double my normal prescription twice daily for 3 weeks (that was a week ago). I've done that, and have felt my strength returning, but I'm still so weak that I need a wheelchair rather than walking any distance. When I saw my Dr yesterday he believed that I could well have had pneumonia, said I was very pale, and put me on a 3-week course of Cipro. He said it's good at fighting all the nasty little beasties that cause pneumonia.

I started the Cipro today, so hopefully I'll feel much better in a few days/weeks.

Tenth IVIG Treatment

Today I had my 10th, and possibly final infusion. I say possibly final because my doctor is in the final stages of getting me switched over to Hizentra Sub-Q! I'm so excited!

The infusion went really well despite the fact that I have either pneumonia or bronchitis right now and am on another round of Levaquin for it! Anyway, I wanted to avoid the battles that we endured last time, and I realized that one thing I'd done which contributed to all of the conflict last time was that I had them keep it at 25 for a whole hour. I was pretty dopey from the premeds and I so when the nurse asked me if I wanted to stay at 25 for an hour I thought I had enough time left in the day to get my whole treatment in easily, so I said "sure, why not?". Because of that mistake it ended up being a very stressful infusion that time.

So this time I went prepared. I told my mom ahead of time what speeds I wanted and how frequently I wanted the transitions. I then wrote them down for her to show the nurse. Because I did that, there was no conflict, and I came up with an arrangement that's slow enough to take care of me without causing them to freak out. I had them start at 25 for 30 minutes, then transitioned to 50 for 2 hours, after 2 hours I had them go up to 75, and keep it there til I finished. I walked into the office at 8:30 AM, and left at 4:00, so I think we did well all-in-all.

Tonight after getting home and having my post-infusion cupcake reward, I took a benadryl, and some medication for my migraine that I've had since yesterday. The migraine is slightly improved, but is still a "back-burner" headache...meaning, it's still there, but I can deal with it.

I hope that I don't feel bad after this one, and I hope that the Hizentra is a good thing for me to use. I have heard a lot of success stories from those who have switched, and it could make my life so much better if that turns out to be the case for me.

Childhood and Early Adolescence

I was born with health problems. For the first 2 weeks of my life my parents had to walk the floor with me and hold me upright so I could breathe. Despite repeated trips to the emergency room and an early diagnosis of asthma, I learned to walk and talk at an accelerated pace, and although I was small for my age, I seemed to develop normally.

I had all of the normal childhood vaccinations, as well as a bad case of chicken pox at the age of 5. I also have eczema, so the combination was brutal. Doctors prescribed antibiotics repeatedly for various respiratory infections, but I don't know what type of respiratory infections they were, or how severe.

When I was 7, my family moved to a cold climate, and I had my first major pneumonia during that very first winter. Mom came to wake me up one morning because I'd slept later than usual, and I didn't wake up. In fact, I was completely non-responsive, and she quickly determined that I wasn't just asleep. She and my dad rushed me to the hospital, and the emergency room staff pumped antibiotics into me by IV. They determined that it was most likely a case of walking pneumonia since no one had known that I was even sick. My white cell count was higher than a leukemia patient's, so they knew that I had a raging infection. After that illness, the doctors told my parents that I was going to keep getting pneumonia until I could go 2 years without needing antibiotics, and that even catching a cold would make me going into pneumonia.

I was referred to an Ear Nose and Throat (ENT) specialist at a children's hospital, and she did a second round of allergy tests, tested me for Cystic Fibrosis, and also tried to determine whether the convulsions that I'd gone into during my pneumonia were related to epilepsy. They confirmed that I had major allergies, but nothing else came of the tests. They changed my asthma and eczema medications, and the doctor told my parents (in front of me, because she was angry) that if I continued having such severe asthma attacks and repeated pneumonias that by the age of 30 I'd have the heart and lungs of a 90 year old woman. Because of that, I grew up thinking that I would die before I reached the age of 30, and had a certain fatalism that you don't expect to see in children.

As it turned out, going 2 years without needing antibiotics has been virtually impossible. There were some years where I'd have pneumonia along with ear infections and throat infections multiple times in one year. I would estimate that by the time I was 15 years old I'd had pneumonia over 20 times, and been hospitalized for 2 consecutive years if you put each stay back-to-back!