Mutterings Of A Mindless Mommy » Asthma

FDA Alert – Stolen Advair Inhalers Sold at Pharmacies

Melissa — Fri, 16 Jul 2010 21:24:37 +0000

If you’ve been reading my blog for any bit of time then you’re aware that my daughter has asthma. After exhibiting the warned neuropsychiatric side effects of Singulair, she was switched to Advair to control her asthma. I just received an alert from the FDA that batches of Advair that were stolen ended up being sold through some pharmacies. If you or someone you know uses Advair Diskus 250/50 or 500/50 please read this notice. My daughter has been on 250/50 during flare-ups but we no longer have that dosage in the house. Her standard dose of 150/50 was not included in this alert.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
[Posted 07/16/2010]

AUDIENCE: Pharmacy, Pulmonology, Patient

ISSUE: Certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

Lot 9ZP2255 – NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
Lot 9ZP3325 – NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)

BACKGROUND: Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhaler used to treat patients with asthma and chronic obstructive pulmonary disease. The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and the FDA continues to aggressively investigate the matter.

Stolen medicine may be harmful because it may have been stored at the wrong temperature or humidity or other improper conditions, may degrade or lose potency, become contaminated, or may have been tampered with or handled improperly while outside of the legitimate supply chain.

RECOMMENDATION: Patients who have products with these lot numbers should immediately stop using them, contact GlaxoSmithKline’s Customer Response Center at 888-825-5249, and follow-up with their physician or pharmacist to obtain a proper replacement.

Pharmacists and wholesalers who find Advair Diskus inhalers bearing these lot numbers should remove them from shelves and contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989. The agency also is asking for the public’s help in reporting any information regarding these inhalers, including suspicious or unsolicited offers for the Advair Diskus lots in question, to OCI or by visiting the OCI website.

The H1N1 Fairy has Visited the Mindless Mommy Household

Melissa — Tue, 13 Oct 2009 21:20:37 +0000

With all her germy sparkliness, the H1N1 Fairy has visited the Mindless Mommy household – not once, but twice. While on a flight to Atlanta last weekend, I wrote about my daughter’s experience with H1N1, Asthma, and a Severe Case of Croup. Last week was relatively quiet in our house but Alexander ended up getting admitted to the hospital Friday night after the Ativan they gave him to stop his seizures caused him to have some seriously hard-core hallucinations.

Unfortunately, the pediatric floor of the hospital was full. As in no…beds..available. The new children’s hospital doesn’t open until next month so they are also working in a smaller pediatric emergency room. We ended up staying in a private room in the ER for the duration of his hospital stay. All around us were children sick with the flu. My hands are still dry from washing them so often but alas, our efforts were for naught. Alexander went from a happy kid yesterday morning to a miserable kid with a 103 fever within two hours.

So now the H1N1 fairy has bestowed her germy sparklies on Alex. He’s in the other room now hacking away but playing video games. Yes, I know, bad mommy, letting him play video games. Hey, he’s sick and so he deserves a little treat, right?

Now I’ve started coughing a bit more and my throat is starting to hurt. However, I don’t have any openings in my schedule until next summer so no H1N1 Fairy, you will not pay me a visit.

Super Nanny Supports Asthma Education Campaign

Melissa — Tue, 29 Sep 2009 03:50:09 +0000

If you were only to look at the title of this post, Super Nanny Supports Asthma Education Campaign, then you’d likely think that this would be a positive post helping raise awareness about asthma. However, the new educational campaign – ASTHMyths, which is sponsored by the Allergy & Asthma Network Mothers of Asthmatics (AANMA), is also co-sponsored by Merck & Co, Inc. Yes, the makers of SINGULAIR are partnering with the Super Nanny and a nonprofit to raise awareness about asthma.

This isn’t the first time that “Big Pharma” has joined forces to create an awareness campaign about “insert disease du jour here”, but since I have a vested interest in the negative side effects of SINGULAIR, I wanted to post about this.

SINGULAIR is known to cause depression in its patients, including children as young as five years old. Yes, that’s right, my five-year-old daughter suffered from depression as a result of using SINGULAIR. We thought it was a wonder drug as it cut our trips to the ER for asthma flare-ups in half. However, when she started talking about dying and no one caring if she was dead, I began to worry.

After a call to our pediatrician, she suggested that we stop the medicine. If the problem persisted, then the pediatrician wanted to see Ava. If the problem stopped, then we were advised to never give her SINGULAIR again. The problem completely stopped and within a week she was back to her happy self. However, we are still dealing with the significant anxiety that started shortly after she started the medication. Right now, we have no end in sight to the end of this sometimes-crippling anxiety that she experiences.

One other point I wanted to make is that I’m not really fond of the Super Nanny. If she had been called to our house to address my daughter’s nonstop crying…for hours every night…she’d have likely placed her in time out to “fix” her manipulations. Only a parent, truly in tune with their child, would be able to see that my daughter’s episodes were not her trying to manipulate me. Instead, it is obvious that something was very, very wrong. Sorry for the tangential Super Nanny rant, not a fan of hers, never have been.

I want to thank Jenna from Parents for Safety for the heads-up on this new project. Jenna works tirelessly to educate parents on the neuropsychiatric side effects of Singulair. Thanks Jenna!

FDA Warns Against Use of Certain Asthma Medications Due to Tampering

Melissa — Fri, 18 Sep 2009 19:43:42 +0000

On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
Lot number 9G04, NDC # 49502-697-29
Lot number 9FD8, NDC # 49502-697-61
Lot number 9FD9, NDC # 49502-697-61
Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62

Advice for Consumers
Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots above and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

Report any information regarding the stolen Dey products to FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

FDA Safety Alert Regarding Xolair, an Asthma Medication

Melissa — Thu, 16 Jul 2009 20:49:39 +0000

FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group).

Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

The ongoing study, titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5000 Xolair treated patients and a control group of approximately 2500 non-Xolair treated patients. The primary objective of the EXCELS study is to assess the long-term safety profile of Xolair in patients followed for 5 years. Study patients are 12 years of age and older with moderate to severe persistent asthma and who have a positive skin test or blood test for an aeroallergen.

The interim data, submitted by the manufacturer of Xolair (Genentech), suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.

FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA has not made any conclusions regarding these data. The Agency is working with Genentech to obtain further information and will continue to review the strengths and limitations of these interim results. For example, since EXCELS is an observational study, there could be differences in underlying risk factors for cardiovascular and cerebrovascular events between the two study groups. The Agency will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.

The FDA urges both healthcare professionals and patients to report side effects from the use of omalizumab to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)

FDA Acknowledges Neuropsychiatric Side Effects of Singulair

Melissa — Thu, 18 Jun 2009 03:58:42 +0000

A big thank you to Jenna of Parents United for Pharmaceutical Safety and Accountability for the FDA update on the negative side effects that children on Singulair experienced (read Asthma, Singulair and Depression for our story).

Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

6/12/2009

Updated information

Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

This information reflects FDA’s current analysis of available data concerning this drug.

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this web page.

Advice to patients and healthcare professionals

* Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
* Patients should talk with their healthcare providers if these events occur.
* Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Background

In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.

The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

My daughter’s depression resolved within a week of stopping the Singulair. However, her anxiety is still through the roof. She is afraid of the smoke detectors and will not walk underneath them. This means that she won’t walk anywhere in the house by herself. She cannot play in her room like a typical 5.5 year old child. Her anxiety is disheartening and I only hope that it gets better with time.

Another Look at Asthma and Car Pollution

Melissa — Thu, 16 Apr 2009 02:13:27 +0000

In February, I posted an article that looks at traffic pollution causing genetic changes in the womb that may lead to asthma. Today, I ran across an article on Reuters that discusses a study that examined a link between poor lung function among adult asthmatics that lived near a road with heavy traffic.

In a study of 176 adults with asthma or rhinitis, Dr. John R. Balmes, of the University of California, San Francisco, and colleagues found “the closer adults with asthma live to roadways with heavy traffic…the lower their lung function.”

“Living close to any road was associated with lower lung function,” Balmes told Reuters Health.

Of course it should come as no surprise that traffic pollution further impairs the lung function of an individual with asthma. My daughter asthma is noticeably worse on days with higher pollution. Take today, for example. We have had sustained wind in the 20s with gusts in to the 40s and there is dust and particulates filling the air. My daughter played outside at recess today for about 20 minutes and came home with a stuffy/runny nose and a cough.

I’m wondering if worsening air quality is going to lead to asthmatics taking drastic measures to improve their quality of life. I can only hope that by the time Ava is an adult, we all have cleaner air to breathe.

Photo by burning image

Traffic Pollution, Genetic Changes in the Womb, Asthma?

Melissa — Sun, 15 Feb 2009 18:55:03 +0000

An article that appeared on the BBC website this morning looks at a possible link between traffic pollution and genetic changes to the baby while in utero that could lead to asthma.

“A study of umbilical cord blood from 56 children found “reprogramming” of a gene associated with exposure to compounds in traffic fumes. The gene was associated with asthma symptoms at age five, the researchers reported in the PLoS ONE journal. It is the first time pollution has been shown to influence genes, experts said. In the study, researchers looked at a gene called ACSL3, which is expressed in the lung.” (Source: BBC)

I live in a metropolitan area that has one of the worst pollution levels in the country. In the winter months, we deal with our own pollution plus the pollution that drifts in from Los Angeles (about 400 miles away). However, I live on the farthest edge of the metropolitan in a somewhat rural area. The sky is blue where we live but 20 miles away in the city, the sky is distorted by the pollution.

I don’t commute to work and didn’t during my daughter’s pregnancy but I did drive into the metro a few times a week. Although in my daughter’s case, I don’t think that the pollution lead to it (she had RSV at age 3 months) but this is an interesting study, nonetheless.

Update on the Singulair/Depression Issue

Melissa — Thu, 29 Jan 2009 03:42:13 +0000

I described Ava’s current situation in the post Asthma, Singulair and Depression. Monday was the last time she received a dose of the medication and we’re already noticing improvement in her weepiness. She still gets sad but she didn’t say anything tonight about not having friends or no one missing her if she is gone. She also didn’t break down sobbing at all tonight. That is good news update number one.

Good news update number two is that we don’t have an increase in asthma symptoms (yet). I can’t help myself by saying yet because in October of November she was without Singulair for about a week and picked up a respiratory bug at school – her asthma symptoms were through the roof. Hopefully with her Flovent 3x/day we’ll be able to avoid it this time.

Asthma, Singulair and Depression

Melissa — Tue, 27 Jan 2009 02:26:13 +0000

Ava has asthma and in October of 2007, after a hospital stay, she began taking Singulair. Singulair is a daily asthma controller medication and for Ava, it has been a wonder drug. She went from visiting the ER one to two times per month for her asthma to going a few times a year.

Over the past six weeks or so, Ava has been incredibly weepy. She will cry every evening saying that she has no friends, etc. She is fine during the day but every night it gets pretty hectic around the house. Since she’s been dealing with obsessive lining up of toys, etc I kind of just blew it off as Ava having a rough patch.

However, the past week she’s been saying some pretty disturbing things, especially for a five-year-old. She has said things like “no one will miss me if I’m gone” or “no one will care about me if I’m gone.” Okay, aside from the fact that these are insightful thoughts and she’s verbally expressing them to me, I found these statements disturbing.

Last summer, I heard about the FDA’s research into a possible link between Singulair and suicide/depression. At the time, I thought, “well she’s only four, we’re fine.” However, the past few weeks I started to wonder again about the Singulair. She gets weepy in the evening and she takes her Singulair before bed every night.

I called the pediatrician today and she said that there is a very good chance it is the Singulair. She mentioned that some clinicians feel that the link is over-stated and that the questionnaire is slated towards responding about depressive episodes. Conservatives clinicians feel very strongly that if there is even a remote possibility that there is a link, then it needs to be considered when assessing patients.

So, the plan is to stop Ava’s Singulair. She said that within a week or a week and a half we should see a noted improvement. If she doesn’t improve, then the doc wants me to call her back so we should discuss other possibilities. Ava goes to see a pediatric asthma & allergy specialist at the end of February and so we’ll have a better idea of how to handle her asthma medication protocol.

Read our good news update re: Ava’s Singulair and Depression issue.