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Keep those pills in shape
Overweight pills are making the news these days.
Barr Labs initiated a recall in mid-August for generic Adderall tablets that may contain too much of the active pharmaceutical ingredients dextroamphetamine and dl-amphetamine, posing a superpotency risk to users of the ADHD drug.
In addition, although recently given a clean bill of health following an FDA inspection, Mylan is nonetheless dealing with fallout from accusations in a local press report that the generics maker's manufacturing employees allegedly sidestepped drug quality controls, yielding medications out of spec for weight, thickness or hardness.
And the recall of Digitek in spring 2008 for possibly containing twice the approved level of digoxin has been followed by other digoxin brand recalls, most recently a version from beleaguered Caraco last May.
Pills become overweight when too much of the drug's API gets weighed out and put in the formulation, says Charlie Carney, a long-time GMP practitioner and consultant who is now an instructor for ISPE. "It doesn't usually lead to an incredibly large increase in mass because the pills are compressed to the same size. So they wind up having greater potency than intended."
It's a big issue that should automatically invoke an internal quality investigation, he says.
"Today, with computer controls, it's hard to hide facts. Whether the problem is found in house and the product is never distributed, an investigation and a fix are required. If it's caught by the FDA in an audit, a much bigger fix is required, sometimes involving retraining for operations personnel and even closure of the plant."
- see the Adderall recall release
- here's our earlier Mylan coverage
- here's the Digitek recall notice
Related Articles:
FDA cites two for GMP lapses
FDA clears Mylan plant after probe
Comments
the overweight tablets can actually be due to two causes..one as described which is a simple weighing error which should have been apparent when the product is tested in QC. However the digoxin tablets had the right amount of active weighed but the tablets were pressed at double the weight required [or so the FDA report seems to indicate]. How can that happen-this is not an assay with a small error..this is a tablet that is double the size and should be obvious to everyone who went near the product, operator, QC, QA. I would love to know how this one happened
the digoxin pills were about twice the amount they were supposed to be but the RECALLED ADDERALL pills were about three to FOUR TIMES (60-80mg) the labelled amount (20mg). I'll repeat that: the recalled pills contained ***60-80 mg amphetamine***, which is 3-4 times what was supposed to be in them. I was supposed to take one and a half pills a day which normally would be only 30mg. With the superdosed pills I unknowingly got and was taking, i was getting 120 mg a day. to put this in perpective, there is a less commonly perscribed adhd drug called Desoxyn. desoxyn is methamphetamine. it is about twice the strength per mg as adderall. it is slightly more effective but doctors don’t like to perscribe it because it is labeled as “meth…†Okay, now look at street methamphetamine, again you have the ratio of being twice as strong as amphetamine. so you need to take twice the amount of adderall to get similar highs, mania, physical side effects as the same amount of amphetamine. Back to me. Because of the drug company’s error, and slowness in letting me know about the recall, I was taking 120 mg (â€30″mg perscribed at 4X strength)of amphetamine, equivalent to approximately 60 mg methamphetamine. 70 (up to 120) mg methamphetamine is considered chronic meth abuse. this is higher than your average recreational user. and we all know the average recreational user of meth usually is not doing too well. at this point i am cutting down on the superdosed adderall slooowly. i am afraid to stop taking the pills because that would cause AMPHETAMINE WITHDRAWAL (because of the extremely high dose)and it would reeeaally suck. normally if you are on 20-40mg of amphetamine (adderall)er day (or even 10-20mg of methamphetamine), if you stop taking it suddenly, the withdrawal is relatively mild you'll feel just fine in a day or two. HOWEVER, for a person taking 140mg plus of adderall (equiv. to ~70mg meth) per day (and for me 120mg is uncomfortably close to that) quitting "cold turkey" can cause severe withdrawal side effects. if you want to know more about long term side effects that can result from this level of amphetamine use, google “chronic meth abuseâ€.
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