A Warning about Singulair!

[Guest guest]

http://wnyt.com/article/stories/S360205.shtml?cat=300

from another list

Another group I am on is discussing some pretty negative stuff about

Singulair. One mom reported that her child's ammonia went way up

soon after taking it. A different Dr. told her to get him off of it

as it can cause liver problems in some, especially children. The mom

took him off and his ammonia returned to normal.

Another mom reported that her 4 yo experienced nightmares and night

terrors that also subsided when the drug was discontinued.

But the

most serious assosciation was reported on a news station about a

normal, healthy 15 yo boy who commited suicide 17 days after

starting the pills. His parents blame the Singulair as they saw

significant negative changes in him soon after beginning it.

Apparently, Merk was aware of these problems and claimed to have

stated these risks in updated inserts. However, Doctors and

Pharmacists interviewed reported differently. Here is the link to

the newscast:

*******

Suicide and a common allergy medication

A Queensbury couple is blaming their teenage son's suicide on the

allergy drug Singulair. The drug's manufacturer says they've been

alerting doctors and pharmacists to the potential for danger, but a

NewsChannel 13 investigation reveals the drug maker's notification

program, at least in the Capital District, is weak and ineffective,

putting allergy sufferers at risk.

Cody was an active 15 year old who took his life on August 4,

2007, just 17 days after starting Singulair for his fall allergies.

Usually he took Allegra but during his back to school physical, his

pediatrician made the change. Singulair was FDA approved for treating

asthma in February 1998 and in 2003 got the green light to treat

seasonal allergy symptoms.

Millions of people have taken the drug.

" He was very sure of the drug and very comforting on the phone

saying, you know this is perfectly, he's going to be better off with

this drug, you know. So I filled the prescription, " said Kate .

Since Cody was their only child, Kate says she was very attentive to

his well being. She checked the Merck website and the information

sheet she got from the pharmacist on Singulair and found no red

flags, so they were stumped when Cody started acting out of character.

" Second week he started having some issues with not sleeping well,

and then sleeping like long periods of time, and leg aches and just

kind of agitated behavior, " said .

" He only had three days of really falling, negative emotional

meltdown really emotional .. yeah, like just shaky, sweating

profusely, actually just, you know, thought well God, you need some

sleep, you know, something wrong, unrealistic fears, " said .

On the last day of his life Cody went upstairs to take a shower

before dinner. When he failed to answer his mother's call, Kate checked on him.

" So I went upstairs and I found my son, " said .

Cody had hanged himself. At the hospital, the Doctors asked about any

drugs he was taking. Kate kept saying, nothing but Singulair.

On October 2, 2007, two months after Cody's death, Merck updated the

warning for Singulair to include suicidal thoughts and actions.

Company spokesman tells me the company received some

post marketing events and changed the package insert, patient

brochures and ads.

assured NewsChannel 13 that drug reps were instructed to share

the information with clients, but none of the doctors or pharmacists

we checked with was aware of the update.

Cohoes pharmacist Mc says he would have liked a heads up.

Mc sells more than 50 bottles of Singulair a month and yet the

inserts in his newest stock date back to April 2007, before Merck

changed the listing of side effects.

Mc checked a special website for pharmacists and didn't even

find a hint of potential for suicide.

" Well it's frustrating to be honest with you, it's very frustrating, "

said Mc.

Pharmacists at CVS and Rite Aid stores we checked with were also

unfamiliar with the update, as were a couple of pediatric groups.

The president-elect of the Albany County Medical Society, who is an

allergy specialist, said he didn't have an inkling of the potential

for trouble.

" I hadn't gotten any messages regarding this and I've talked to some

of my colleagues and they were totally unaware of it, " said Dr. Shulan.

And his newest drug samples were still packing old inserts without

the latest information.

" And this is what's meant for the patients, " added Shulan.

The Singulair website carries the updated side effects, but you have

to search it out in the patient information PDF on the fourth of five pages.

If you check with the FDA, you'll find nothing. As they told us, they

haven't updated their website on Singulair since 2001.

While the Merck spokesman couldn't give NewsChannel 13 a count of

cases that lead to the update, he said a warning does not reflect a

conclusion. He said an adverse event can be caused by many things

including, genetics, disease, or a background event.

For the s, there was only one event, the death of their son.

" Something has to be done. Somebody you know, go in the right

direction, because as a parent, as a consumer of a drug you should

know all the risks and the benefits and then you can make your own

decision, " said .

Anytime you experience a change in health or behavior after starting

a new drug, tell your doctor, don't stop the medication.

If you have a bad reaction to a drug, you can post it on the FDA website.

There is also a consumer website you can check to see if anyone else

has had an adverse reaction.

We've set up links on our website.

On Thursday, February 28, 2008, the FDA opens two days of hearings on

risk communications.

Issues like this may be addressed and Merck says they are always

looking for ways to improve their communication.

The company says, in this case, they believe the level of

communication is appropriate for the level of the label change.

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm Vaccine Dangers &

Childhood Disease & Homeopathy Email classes start in March