Shortage of ADHD drugs

Posted on October 30, 2011 by Linda

We can't get our ADD meds and we're losing focus faster than a defective camera lens. What gives?

First, everyone (OK, doctors) convinced us that we should take meds for our ADD. So we get our prescription filled, our brains come to attention, we get things done and then ... and then ... no medication!!!!

Is it a conspiracy? Is it corporate manipulation? Is it ghosts on Halloween?

Well, it's probably not ghosts but there aren't clear reasons for the shortage of ADHD medications, especially mixed amphetamine salts (a.k.a. Adderall and its ilk) and methylphenidate (a.k.a. Ritalin).

The FDA website (http://www NULL.fda NULL.gov/Drugs/DrugSafety/DrugShortages/ucm050792 NULL.htm) reports that the Adderall shortages are caused by a variety of issues, mostly about "API" shortages. API stands for "Active Pharmaceutical Ingredient." According to Drug Store News more than 80% of the API needed to manufacture drugs in the US comes from OUTSIDE the United States! Most of the active ingredients come from Italy, China and India. So if the supply slows down abroad, our meds in the US are affected.

It is truly a global world of pharmaceuticals these days. The FDA requires that the API produced outside the US meet the same high standards for quality as those produced domestically. But ... and here's the shocking fact ... drugs produced overseas are NOT highly regulated, even for export to the US and other countries. As recently as 2008, there was a single FDA inspector assigned to China. As in one person. One.

OK, don't get me sidetracked into a discussion about the purity of drugs. This is about shortages. However, concerns about the purity of the API can delay production, too. The FDA took action against a Mexican API production facility in June 2011, which delayed manufacturing (this was not an ADHD drug API).

So...as of October 28, 2011, the FDA reported that Immediate Release Mixed Amphetamine Salts (Adderall and generics) are delayed because of API shortages (brand name Adderall), higher demand and manufacturing delays.

For Adderall ER, the picture is similar, but Shire Pharmaceuticals (who also produces Vyvanse) claims there is no shortage at the manufacturing level. There are some distribution inequities, though. So one part of the country might have a plentiful supply, while other areas may experience a shortage ... sigh.

Ritalin/methyphenidate - things are grim. As of October 11, 2011, Sandoz (which manufactures generic Ritalin) predicts "sporadic backorders" for the next couple of months. The only manufacturer who has plenty of generic Ritalin (methylphenidate) is Watson Pharmaceuticals which apparently has a lock on the market right now.

Metadate, a branded formulation of methyphenidate that comes in the CD, IR and ER variations, is at full supply from UCB Pharmaceuticals.
Metadate CD

The other formulation that is bountiful at the moment is Daytrana, a brand name formulation that is administered via a time release transdermal patch (applied to the skin). Noven is the manufacturer of Daytrana.

Bottom line is that some important meds are missing from our ADHD arsenal right now and nobody seems to be talking about it ... unless you are one of the unlucky ones who can't get a prescription filled.

What's your experience? Let us know where you live and whether you can get meds in your area. We need to help each other on this vital issue!

Warning! Doctors can sell your Rx history to Big Pharma

Posted on June 26, 2011 by Linda

In yet another consumer-bashing move, the US Supreme Court ruled June 23, 2011, that pharmaceutical companies may now purchase lists of the drugs that individual doctors prescribe (without the name of the patient) for marketing purposes.

The ruling was made using the First Amendment Freedom of Speech argument that if researchers and journalist were allowed to gather such records, then marketers deserved equal access. Um, this doesn’t exactly seem like freedom of speech to me. It’s more like data mining. And that pretty much sucks.

Not only do the pharmaceutical companies not need to know what drugs our doctors are prescribing to us (even anonymously), they don’t need to be putting pressure on doctors to prescribe more of their particular drug.

What I hear from doctors is that they feel besieged by drug reps who pound them with expensive brochures, volumes of research and "educational" materials. There is unprecedented marketing influence over our most personal body mechanics. I, for one, don’t like it a bit.

One consumer advocate said that the ruling could create a conflict of interest for physicians who must fight to maintain the best interests of their patients while being bombarded or pressured by pharmaceutical companies.

Having come of age in an era when consumer protection was firmly entrenched in the culture (although I might have been naive about my trust), it’s still a shock to see just how little our individual needs influence the marketplace. And make no mistake, the medical field is a marketplace; has been for more than a decade. I hate it. I hope we can withstand the commercialization of our health. Even more, I hope we can survive it.

Warnings on generics: Supreme Court rules against consumers

Posted on June 25, 2011 by Linda

I am outraged!

And more than a little scared.

This week, on Thursday, June 23, 2011, the US Supreme Court ruled 5-4 against two women who claimed that they were not properly warned about the risk of taking a generic equivalent drug, (http://www NULL.latimes NULL.com/health/boostershots/la-heb-generic-drugs-20110624,0,5484443 NULL.story)saying that consumers were not allowed to sue for side effects not listed on the label. The justices said the generics companies didn’t have the same responsibility as brand name pharmaceuticals to update their warning labels when new side effects were discovered.

Are you kidding me?

Those generic drugs, the ones pushed hard by insurance companies because they cost less, the only ones that some people can afford to take, are not even required to toe the same line for warning labels as Big Pharma? Ridiculous. Absurd. And dangerous.

The two women, Gladys Mensing of Minnesota and Julie Demahy of Louisiana took a generic equivalent of Reglan (originally developed by Wyeth) to treat acid reflux for about four years and developed serious neurological symptoms (involuntary muscle movements). Although the Supreme Court did not dispute that the symptoms were side effects of the generic drug, it said that companies who manufacture generics should not be held to the same standards as research pharmaceutical firms to add new warnings to their labels. Their contention is that the original warning label is sufficient for a generic equivalent.

Justice Clarence Thomas wrote that the reason generics were granted special exemption was that "It is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public."

But what about our safety and our right to full disclosure? Is the tradeoff for cheaper prescription prices an incomplete warning label about a potentially long-term, debilitating neurological condition? In this case, apparently so.

What does this mean for generic manufacturers? That they may skip merrily down the road producing medications that may or may not negatively impact the end user without telling us about newly-discovered problems.

What does this mean for ADD medications? It means "caveat emptor" – let the buyer beware. The drugs that are "off patent" may or may not have new, serious side effects. But if we take a generic we’ll never know, because there is no requirement that we be told about them. And now, no way to seek legal recourse against the company that produced the drug.

I am reminded of the severe warnings issued to cash-strapped consumers who ordered prescription drugs over the internet from foreign countries. There was no published warning of the purity or efficacy of the mail order drugs. Isn’t that exactly what is going on here? Granted, it is not a contamination or substitution problem, but we are buying (and taking) life-saving drugs without updated information about their potential for damage. So how can we know whether the generic we are taking is prone to cause problems that appeared after the original FDA approval? We can’t, thanks to the Supreme Court.

If Reglan was still under patent, Wyeth Pharmaceuticals (now part of Pfizer) would certainly be held responsible for warning the public about these serious side effects. But not the generic companies. This ruling allows generic drug manufacturers to hide the bad news from us. Until we experience them first hand.

Now I am even MORE outraged.

I will continue to request brand name prescriptions from my doctors. Thank goodness my health insurance still pays for them. My fingers are crossed that yours does, too. Which doesn’t mean those side effects on the label make me feel safer. But at least I know the possibilities.

Tell me about your prescriptions — do you take generics or not? Are you outraged too?

Wellbutrin generic – bad news?

Posted on November 4, 2007 by Linda

I’ve always worried that generic drugs aren’t quite as good as the brand name version and now there’s mounting evidence to prove it.

Wellbutrin XL 300 (Budeprion XL) works just fine for depression and many ADHD symptoms. But when some patients are switched to the generic formulation, they reported frightening symptoms: fast onset of severe depression and serious suicidal thoughts.

In a recent article published by the People’s Pharmacy (http://peoplespharmacy NULL.com/)a woman reported no problems with the original Wellbutrin XL 300 but said that she had "the worst case of depression" she could remember when her pharmacy substituted the generic equivalent. It should be noted that the difference has not been reported in the 150 XL formulation at this point.

Apparently the generic version releases the medication at a different rate than the original, thus creating quite different response rates and effectiveness.

This news scares me – because a lot of ADDivas take Wellbutrin, including me – and there is the potential for serious repercussions. Suicide is not to be taken lightly, especially when antidepressants are supposed to ward off those thoughts and actions.

Equally important, however, is that many ADD women and men have already experienced differences in generic medications vs. brand name drugs that treat ADHD. I cannot take generic Adderall, for instance. Other people cannot take the brand name version. Ditto for any of the other drugs on the market today.

There are two ways to look at this issue, in my opinion.

1) We need to make SURE that we are receiving the exact drugs prescribed for us with NO substitutions by the pharmacy or insurance company (this may take some lobbying by you or your doctor).

2) If generics really do release their active ingredients at different rates than the original drug, it gives us even MORE options to play with to treat our ADHD symptoms.

After all, drug companies are making a fortune by adjusting the release time of ordinary drugs like old fashioned Ritalin, slapping their brand on the bottle and charging 10 times the price of generics. I know folks who can’t take the brand name drug but have good results with the generic. It works both ways. But the bottom line is the same: we all react differently to medication release schedules, to the type of drug prescribed, to the interval we take the drug, etc.

OK, now the disclaimer: this is NOT something to play with on your own. Obviously there can be serious consequences. Drugs are not a smorgasbord from which we can pick and choose. Work with your doctor to find the best combination for you.

But if you are switched to a generic and suddenly notice your symptoms change, call the pharmacy AND the doctor immediately. You deserve to take the meds that work best for you,
brand name OR generic.

Read the full report at Consumer Lab. (http://www NULL.consumerlab NULL.com/)