Focalin Shortage (Page 2)
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My son has been on Focaling regular release for two years, we have never had a problem getting his medicine filled until this past month. Since he was diagnosed at 4 we have tried EVERY other medicine out there but nothing works for him but Focalin. He is finally where he needs to be and is doing well at home and in school. I am not sure what to do, is there any idea when this shortage will be over? He takes 20MG in the monring 15 at lunch and 10 in the afternoon. So our prescription is fairly large. He cannot take the XR because it has to many ups and downs. It is sad that because of the drug abusers that my child who cannot function without this medication cannot get what they need. It makes me SICK that some of these comments are from adults just using this drug to have energy or to get their housework done. Our son needs this to be a normal child, to be able to go to school, to be able to play with his friends, to be able to play baseball. If you are using this drug just for the fun of it please go and find something else to catch a buzz with. Do not take the drugs little kids need away from them for your selfishness.

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54

I am in Kentucky and having the same issue. My son takes 40XR in the morning at 10IR at lunch and another 5IR if needed in the evening. We are finally in a very good spot and I am furious that this is happening. I ordered it from the mailorder pharmacy through our insurance and he said that the name brand (which they had in stock) would probably be going out as well before I need to have his prescription refilled. Hopefully the release in March of the namebrand will help. It absolutely drives me crazy how the addicts and the ones who abuse prescriptions hurt those who use it properly (especially children). It drives me crazy having to go to the pharmacy every month to have his prescription refilled and god forbid you get there one day early...it's absolutely ridiculous.

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53

My son went to the doctor today and switched his 5mg IR focalin to the 20mg XR. Good news is it's in stock. I just know that the 5mg is not available at all.

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52

Good News and Bad. Good is that the FDA has finally added both the brand and the generic to the national shortage list. I was told by a reporter at the NY Times that the FDA had been bombarded by shortage complaints. So, it looks like all the emails helped. Another piece of good news is that Novartis is releasing branded quantities in early March according to the FDA website. The Bad news is that the generic will likely not be available - again, according to the FDA website - until the end of the June or even well into October for some strengths. The generic manufacturer, Teva, lists the reason as a raw material shortage. Not sure why the raw material shortage is impacting Teva but not the more expensive branded version at Novartis?? In addition, Novartis attributes the shortage due to increased demand while Teva says the shortage is because of the raw material issue. Now that these drugs are on the shortage list there will be added pressure to resolve this in a more timely fashion. It is sad that it took so much public pressure to get the FDA to list these drugs as being scarce but at least they did and maybe the sunshine on the problem will help deter these companies from allowing the drugs to become scarce in the future.

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51

Try getting it at any pharmacy right now

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50

I found some at a smaller pharmacy in Birmingham but not the generic but oh well. The Wal-Greens near me said they are releasing it March 1st for generic and name brand so maybe there is a light at the End of the Tunnel.

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49

I am just overwhelmed with the responses and heart broken over all these kids who are suffering because of this companies lack of care and concern. We have had to change our son's medicine we have went to time released Focalin XR 30 mg and then to ritalin in the afternoon. The XR is working pretty good but the ritalin is not doing anything. The after school worker said he is getting aggravated with his friends etc. I am going to contact everyone that you all suggested

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48

I also have a child that takes Focalin 5mg as her afternoon booster and we are having a hard time here. Does anyone know of any pharmacies in Birmingham, Alabama that may have it?

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47

I have tried to get the NY Times and the WSJ to pick up the article but I was told a story had already been done about a year or so ago. I checked and there is an older story about the fight between the DEA and FDA over overall drug allotments of ADHD medicine. Something different is going on now because even Teva will tell you that they are on hold and it has nothing to do with the quotas (but that want say what it has to do with). I have spoken to an FDA rep and they BELIEVE it is due to a shortage of some raw materials but that is unconfirmed. Novartis will ship again in March so some will be available at brand name prices in mid March. As for the generic, Teva says that they cannot tell you when they can ship again as it is proprietary information. Break out your wallets for the brand name Focalin is all I can tell you.

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46

People having problems with the shortage should contact their local news station. I did and in only a matter of minutes I got a reply from an investigator wanting to do the story. If we raise awareness then maybe we can make a change.

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45

I was told by a pharmacist that the DEA, not the FDA, controls one of the key ingredients/components of Focalin and its generic equivalent. I was stunned by that disclosure. There is a govt website that confirms it is a shortage of one of the ingredients and says it will be on back order till mid-March by all manufacturers. fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm

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44

I can't be more upset about this stupid shortage. Only four days off the Focalin and my son has scratched three times. I didn't realize how well the meds were working until he got off of them. I dread what will happen if he causes a serious injury to someone. And all of this could be avoided if he could only have the medicine that was helping him.

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43

I see that they are telling ppl 6-8 wks but I couldn't get it last month and now I'm dealing with it again this month. I can't afford to keep getting the brand name. My son has been on everything . He is finally on the right dose and is doing so good in school. I can't rock his world by stopping it. This isn't right and they know it these poor kids!

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42

I have the exact same issue with my 12 yr old daughter , mild Aspergers and ADHD . We've been through every rx on the planet and finally had the right dosage. Now we have her 20 mg Xr in the morning and can't find her 5mg IR anywhere. I found out the hard way at the pharmacy today! What are we to do??? I have less than a weeks supply and am terrified she could relapse and end up back in the hospital like before! Any ideas or help would be greatly appreciated.

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41

Everybody who gets a form letter from the FDA stating that a national shortage does not exist can send an email requesting a review to the FDA ombudsman. The email address is [email protected]. I was also told by the legislative liaison at the American Association of Pharmaceutical Professionals that contacting your local federal congressperson is probably the most effective way to help solve this issue. If Congress intervenes to the FDA then the FDA will approach Teva and Novartis and request an action plan even if, for whatever reason, the drug is not listed on the National Shortages list. Anyway, please email the ombudsman and your congress person. This is a national shame and I feel so bad for the children and parents on here, especially the ones with serious illnesses that make my son's ADD seem rather minor. God Bless all of you that are suffering big time. I have asked a couple of national reporters to review this issue but none have "bitten" on it yet. Maybe one will and it will get some national press.

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40

Thank you!!!!

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39

Today I spoke with Mr. Spira who is, as I understand it, a legislation liaison at the American Pharmaceutical Professionals Association and he said he is aware that this a growing issue and that Teva is inaccurately telling people that it is a quota problem. Evidently his association is gathering complaints to get action taken at the federal level. His association also has the power to directly impact a drug being added to the National Shortage list (which Novartis and Teva do not want to happen as remediation plans are required if that happens). I urge you to email the problems you are experiencing to Mr. Spira. His email address is [email protected]. He was very helpful and said that the more people they hear from the better and quicker they can help address the issue.

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38

[email protected] This is the address I sent my e-mail to. It is to report shortage or drug supply issue. If there is an issue then it should be on the list, but it is not. So I gave them a link to this sight in hopes that they will take a look at our concerns and hopefully look into it.

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37

The quota shortage is a myth. I have talked to the DEA and asked TEVA point blank if they were under the quota and Teva told me that they were under the quoto. The DEA confirmed this to me. They want to blame the quota but when you press them they admit it is a "supply" issue but will not confirm the reason. Everybody needs to report this to either the FDA shortages email address or report it to the American Association of Pharmaceutical Professionals. The manufacturer is supposed to "self report" but evidently that is not happening

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36

In five days my son will be out if his meds. :( He is autistic and is so sensitive to the changes in his environment. I will be going back to his doc to change meds. This is so unfair and ridiculous. He has had such a hard time with his behavior and I finally got him on the right medication only now to change it again. Which will mean a whole cycle of emotions to go through with him. I am beyond angry and upset right now. Are others here running out and forced to switch meds? What have you been changing to?

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35

I too have searched high and low in Chicago and no one seems to have it nor can they tell me when it will be available. Also sent and email to the FDA on shortages and they stated "We are doing everything within FDA's regulatory authority to ensure that the product listed in your email continues to be available for patients. We have reviewed the market availability of this product. At this time, we are not aware of any shortage of Focalin and/or its generic, dexmethylphenidate. We understand the important need of this drug. Please visit the drug shortage web page for supply information and a list of ongoing efforts to help resolve drug shortage issues. You may also check the ASHP Drug Shortage website."
This is ridiculous

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