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Is Your Child Outgrowing Her Generic Concerta Dose?

Methylphenidate (also known as Concerta).

Methylphenidate (also known as Concerta). (Photo credit: Wikipedia)

Written by Kristen Stuppy MD. Dr. Stuppy is a practicing pediatrician in Kansas. She feels privileged to be able to help families keep their children healthy and she loves watching entire families grow!  Dr Stuppy is active on Facebook and puts a more personal touch to pediatric topics on her blog.

Generic Concerta Not Working Like the Brand Used To? It might not be that you’re outgrowing the dose…

I used to be a huge fan of generics. They save money, right? They are equivalent to the brand name, right?

That’s what I’ve always been taught and what I teach.

I’ve been jaded by many problems and now disagree with the above. Generics aren’t always cheaper than the brand name. Some generics are not equivalent to the name brand.

A recent discussion on a psychology/pharmaceutical listserv I follow brought up the issue of generic Methylphenidate HCl not working as well as the brand name Concerta. Several members had some great insight into why this is.

The discussion peaked my interest in the issue and I started looking online for information earlier this week.

Ironically today I went to pick up a family member’s medicine. We have filled at the same pharmacy previously for generic “Concerta” and have always gotten the equivalent generic.

When I looked at the pills in the bottle today, I told the pharmacy tech they weren’t OROS (see below). She looked confused. She had no clue what I was talking about.

(Lesson to all: if you have any questions, ask to talk to the pharmacist. Hopefully they will understand the pharmacology better than the tech.)

Generics for Concerta (Methylphenidate HCl) might have the same active ingredient, but have a completely different time-release system, resulting in varying drug peaks in the bloodstream.

The original Concerta (from Watson pharmaceuticals) uses a special technology to time-release the active drug. This time-release technology is called OROS (osmotic controlled release oral delivery system). There are several other time-release methods.

The active ingredient may be imbedded in various substances from which the medicine must exit slowly or a gel cap is filled with beads that dissolve at different rates. With the technology used by Concerta, the capsule IS the time release. It doesn’t dissolve.

The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. See this photo from Medscape.

Screen Shot 2013-05-13 at 9.43.07 AM

I have recently learned that not all generic formulations of Methylphenidate HCl are using this technology. This alters the time-release nature of the active medicine.  For some people this substitute might be just fine, or even preferable.

But if it seems like your medicine isn’t lasting long enough, has times that it works well followed by times it doesn’t until the next peak, or any other problems — check your pills!

You can tell the difference by closely looking at the capsules. The OROS capsules are a unique shape, a little more blunted than a standard capsule. If you look really closely at the ends, you will find that one has a “dimple” where there is a small hole covered by a thin layer matching the rest of the capsule. I just happen to have at least one of three dosages.

IMG_0564

So if any medicine doesn’t work like it used to, look closely at the pill itself to see if it is the same as previously. If you don’t have any left, ask the pharmacy for the company / maker of the medicines you’ve filled over the past several months.

Let your doctor know if you can’t use a substitution so they can specify “Watson brand only.”  If the new “brand” works better, be sure to ask for that manufacturer.

Do not ask your physician to simply increase dosing, because with the next prescription you might get the OROS pill, and the new dose will be too high.

Ask which manufacturer makes the generic for Concerta sold at your pharmacy. Watson Pharmaceuticals is the one that is approved by Ortho McNeill Janssen Pharmaceuticals to market the OROS system pills.

Mallinckrodt markets another type (not OROS) in the US. If your pharmacy doesn’t use your preferred pill type and you plan to shop elsewhere, be sure to let them know why!

 

Reporting Adverse Events: If you have an issue with the duration of action of a different brand of Methylphenidate HCl you should report it to the FDA. This will allow them to review cases and possibly stop the substitution of these non-equivocal products. Click on this link for the MedWatch Report.

Resources:

The Pre-MMA 180-Day Exclusivity Punt? What Gives? A legal blog explaining how medicines lose their exclusivity and can become generically available, specifically the Concerta dispute.

How To Tell The Difference Between Concerta and Generic Concerta A Canadian ADHD blog provided the picture of how to recognize the difference. Generic formulations have been available in Canada years prior to in the US.

Special thanks to the members of the Child-Pharm listserv!

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10 Tips To Help Your Child Make The Medicine Go Down

Written by Denise Somsak MD
Explain that medicine needs to be taken to make your child feel better.  Around the age of three years old, this explanation will have much more meaning and may increase ease of compliance. In the words of Yoda, “Truly wonderful, the mind of a child is.”  They sense your compassion and conviction.  You don’t need luck.
  1. Ask your doctor before you start.  Better to avoid screaming than to manage it.  Some kids do better with liquid others chewable.  Many medications can be crushed and put in food.  Pharmacist can add flavoring to liquid medications.  This is usually better than adding the medication to juice or milk because not all meds can be mixed in other beverages and more importantly, the child might taste it and refuse the rest leaving you with an even larger amount of liquid to get down.  Rectal medication is sometimes an option, but few medications other than tylenol, anti-emetics and seizure medications are made for this route.
  2. Know you can.  There is no try.  Only Do or Do Not.
  3. You need a syringe.  No, not to give the child a shot.  An empty syringe that you can fill with the correct amount of medicine.  The pharmacy should have given you one.  Always ask especially for children less than 3 years old.
  4. Make sure the child is not afraid of the syringe.  Let him hold it.  Fill it with water and let him sip it and drip it into his hand.
  5. If the child will try a little medication willingly, give a little more.  If the Force is with you, that’s all it takes.
  6. If the child does not like it, promise a chocolate milk chaser or some other highly desired treat that the child can only earn after the medication and at absolutely no other time.  This technique only works for children who can understand cause and effect and delayed gratification, about 2.5 to 3 years old and up.
  7. If the child spits the medicine back at you immediately or vomits within 10 minutes, you need to repeat the dose.  Call your doctor with variations on this theme.
  8. To avoid the spitting, lie the child on her back.  You might need a holder to steady her head.  Slowly drop the medicine in a little at a time by putting the syringe at the back of the throat, but DO NOT GAG the poor girl.  A few drops at a time even during crying should get the job done.  It will feel like forever, but I promise you it is less than a minute.  She might cough a little.  Go slow.
  9. If she will not open her mouth, gently hold her nose until she does.
  10. Do not reward the child for protesting.  In other words, refusing and protesting the first dose should not mean that he never has to take it again.  In the words of Mary Poppins, “Be firm but kind.”

Always keep medicine safely out of the reach of children and never confuse them by calling medication candy.  Apparently this is confusing enough according to recent research presented at the National AAP conference which showed that both kindergartners and teachers had difficulty telling the two apart.

 

Dr. Somsak was born and raised in the heartland. She describes herself as a no frills, practical gal.  She writes regularly at http://www.pensivepediatrician.com

HPV Vaccine Unsafe? Pediatricians Weighed In

Written by Brandon Betancourt

Recently, a parent of one of our patients sent us a link regarding the Gardasil (HPV) vaccine and the claim that it doesn’t protect against cervical cancer.  The headline of the article the parent sent me is titled “Merck Researcher Admits: Gardasil Guards Against Almost Nothing.”

I had never heard of this claim before, so I asked a group of pediatricians what they made of this allegation and if they knew Dr. Diane Harper, the person quoted in the blog post. I also asked if they had any thoughts on the article itself; which was posted by the Population Research Institute, a non-profit organization tasked to debunk the myth of overpopulation.

I got quite bit of feedback that I’d like to share with you because I think it is important for objective individuals to dissect these claims and set the record straight.

By the way, if you would like to read the actual article by the non-profit that makes the claims, you can Google it. I really don’t want to send any traffic to the site. So I’m only going to quote on the pieces that the pediatricians commented on.

The first one to respond, was Dr. Zurhellen. He had an issue with this line from the article:

“…1 out of 912 who received Gardasil in the study died.”

Here is Dr. Zurhellen’s response to that:

If, really, 1 out of 912 girls vaccinated…died…from the vaccine…could this be hidden from us ?  Since over 38 million doses have been given, and that probably represents about fifteen million women/girls…that would translate as sixteen thousand (rough round-offs…) deaths.    Where was the media coverage of 16,000 vaccine deaths?  Nowhere since it did not happen.

Dr. Berman had a very practical analogy that actually makes a lot of sense:

This is kind of like saying seat belts don’t do a thing to prevent drunk driving, so what good are they?

Dr. Horowitz emphasized that in order to deconstruct Dr. Harper’s claims, one needs to understand how medical studies are done, understand the natural history of diseases or medical statistics.

For example, he quoted this from the article

70% of HPV infections resolve themselves without treatment in one year. After two years, this rate climbs to 90%. Of the remaining 10% of HPV infections, only half coincide with the development of cervical cancer.

And had this to say:

So let’s do the math: “only” 5% of cases of HPV infection are associated with cervical cancer. Given infection rates of about 50%, this amounts to 2.5% of the total female population at risk for cervical cancer. This is an enormous number of women.  In the millions…

Dr Horowitz had an issue with this statement as well:

“the death rate from cervical cancer continues to decline by nearly 4% each year.” Let’s do the math. If the 4% annual decline in cervical cancer death continues, in 60 years there will have been a 91.4% decline in cervical cancer death just from current cancer monitoring and treatment.

So let’s attribute this to better overall medical care in general, and earlier detection specifically. However, it is ludicrous to expect this diminution of death rates to continue forever. You may be able to squeeze 2 qts. of water out of a sponge, but it is silly to think that this is a linear relationship, with the amount of water per effort being the same with the 1st squeeze and the 10th.

“The rate of serious adverse events is greater than the incidence rate of cervical cancer.” 

Unfortunately, she shows her ignorance in not understanding what a serious adverse event is. I believe that every kid who fainted had a (serious?) adverse event.

Dr. Lessin added:

A serious adverse event is defined by the FDA as one that causes hospitalization or death.  Extremely few were reported.  The FDA also requires that every event that happens after a research intervention be reported.  This is why you see ear infections as a side effect of many medications.  Clearly there is no causal relationship other than the person got an ear infection around the time of the trial.

Others weighed in as well.

I tried to learn a bit more about Dr. Diane Harper and found numerous articles where she says was misquoted quite badly in other articles, some of which were picked up by the likes of CBS and MSNBC.

… there is some accuracy mixed in with what I would consider a careless disregard for fact. For example, of the 15,000 (now 19,000, depending on the article), adverse effects reported to the CDC, 94% were non-serious, such as swelling around the vaccine point or fainting after receiving the vaccine. Of the 6% that were serious, they have been closely monitored. Of the 23 deaths reported since the vaccine was introduced, none of the deaths were linked to the vaccine.

John Canning shared a Medscape article titled HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events (if you click on the link, Medscape will ask you to signup. But if you Google the title of the article, you can go directly to the article.)

The article is interesting and I encourage you to read it, but in essence, it concludes with this:

“Based on ongoing assessments of vaccine safety information, the FDA and CDC continue to find that Gardasil is a safe and effective vaccine,” the agencies said in a statement released on July 22, 2008. “The benefits continue to outweigh the risks,” they said. “This vaccine is an important cervical cancer prevention tool,” they added.

The takeaway is this

The HPV vaccine is highly effective in preventing four types of HPV in young women who have not been previously exposed to HPV. This vaccine targets HPV types that cause up to 70% of all cervical cancers and about 90% of genital warts.

Moreover, the vaccine has been licensed by the FDA as safe and effective. This vaccine has been tested in thousands of females (9 to 26 years of age) around the world. These studies have shown no serious side effects.

Dr. Harper was very likely misquoted.  If not, then she clearly does not understand statistics or causation and draws conclusions based on her opinion, rather than the facts.

To read more, visit the CDC’s website or click on this link.

Brandon is a practice administrator. He blogs regularly on practice management issues at PediatricInc.com. He and his wife (a pediatrician) are pro-vaccine and have vaccinated their  3 children with all the age appropriate vaccines. 

Does Apple Juice Contain Dangerous Levels of Arsenic?

Written by Lacey Raburn, MS, CLC

On September 14, 2011, “The Dr. Oz Show” claimed that, through independent testing of selected samples of apple juice, they found unsafe levels of arsenic. This report would, of course, alarm many parents who provide apple juice to their children. Unfortunately, Dr. Oz failed to convey the entire story to the general public. For this the ABC News Health and Medical Editor, Dr. Richard Besser, publicly accused Dr. Oz of “fearmongering” on the popular show “Good Morning America.” 1

A little background on arsenic

Arsenic is a metal found in everything from our water to air. There are two types of arsenic: organic and inorganic. Organic arsenic is naturally occurring and not absorbed by our bodies. Because of this, it is not thought to have any harmful effects. Inorganic arsenic is not naturally occurring and can be harmful if consumed in large amounts and for a long period of time. The level of arsenic determined to be safe in drinking water is less that 10 parts per billion; most of the arsenic found in drinking water is inorganic. 2 3. Apples and apple juice contain organic arsenic. 4 Additionally, there are some levels of inorganic arsenic in apple juice; however, this is usually a fraction of the total arsenic and well below acceptable levels of inorganic arsenic in drinking water. 4

Measuring arsenic in apple juice

When arsenic is tested in apple juice, first the total arsenic levels are reported.4 This is a measurement of both organic and inorganic arsenic. If the total arsenic levels are high, the levels of inorganic arsenic are measured. Usually, the inorganic arsenic levels are well below what is considered safe. If they are too high, the Food and Drug Administration (FDA) will alert consumers. The FDA has regularly tested arsenic levels in foods and juices for many years to guarantee the safety of those foods. 4

Dr. Oz only reported levels of total arsenic in the apple juice, not inorganic levels. Also, he obtained all of these reports from one lab. When the FDA learned of Dr. Oz’s intent to report these findings on television, a letter was written that alerted the producers that this data did not accurately reflect inorganic arsenic levels. 5 Additionally, two more labs obtained samples from the same lot that Dr. Oz tested to determine total arsenic levels.6 Their results indicated much lower results of total arsenic compared to those that the lab Dr. Oz used. From this, the FDA concluded that the first lab’s results were unusually high and most likely a result from an error in the testing process. Another letter was written to the producers of the show encouraging them not to air the episode as it would cause unnecessary fear among consumers. 6 The following is an excerpt from this letter:

“In short, the results of the tests cited above do not indicate that apple juice contains unsafe amounts of arsenic. The FDA reaffirms its belief, as stated in our September 9, 2011 letter, that it would be irresponsible and misleading for the Dr. Oz Show to suggest that apple juice is unsafe based on tests for total arsenic.”

The FDA also released an update reassuring consumers of the safety of apple juice. 4

The bottom line

According to the FDA, apple juice is safe to drink and the levels of arsenic found in apple juice are well below what is considered safe and acceptable.

If you would like to read more information on this topic, please visit the FDA website.

References:

1. Gann, C. Apple juice and arsenic: Dr. Besser vs. Dr. Oz. 2011. Available at: http://abcnews.go.com/Health/dr-richard-besser-dr-mehmet-oz-debate-arsenic/story?id=14526426. Accessed September 15, 2011.

2. Arsenic in Drinking Water. 2010. http://water.epa.gov/lawsregs/rulesregs/sdwa/arsenic/index.cfm. Accessed September 15, 2011.

3. Questions and Answers: Apple Juice and Arsenic. 2011 http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm271595.htm. Accessed September 15, 2011.

4. FDA: Apple Juice is Safe to Drink. 2011 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm271394.htm. Accessed September 15, 2011.

5. Zink, D. Letter from FDA to “The Dr. Oz Show” Regarding Apple Juice and Arsenic (09/09/2011). 2011. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm271630.htm. Accessed September 15, 2011.

6. Zink, D. Second Letter from the FDA to “The Dr. Oz Show” Regarding Apple Juice and Arsenic (9/13/2011). 2011. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm271632.htm. Accessed September 15, 2011.

Lacey Raburn, MS, CLC is a dietician at Plateau Pediatrics in Crossville, Tennessee.