Sunday, April 08, 2007

FDA Drugs: February 2007

2007: Mar | Feb | Jan . . . 2006: Dec | Nov | Oct | Sep

FDA Drugs: February 2007

  • Warning Letter: Signature Genetics. Seryx is the company that markets an excellent (but expensive) pharmacogenetics program which will take your blood or cheek cells and analyze your DNA for various genotypes which affect how your body metabolizes certain drugs, many of which are psychotropic drugs. This information may be used to help a prescriber make decisions about starting dosages or drugs or combinations of drugs to use or avoid. This topic is a whole 'nother post I could do, but this type of testing can be used inappropriately (2002 Quackwatch page), as well. Anyway, this computer program is considered by the FDA to be a "device", and it has not applied for FDA approval, so the FDA is telling it to stop until approval is obtained.
  • Wellbutrin (bupropion) Medication Guides updated: PDF versions of Medication Guides for Wellbutrin and Wellbutrin SR were updated.
  • Generic Focalin (dexmethylphenidate) approved.
  • Only 22 New Drugs Approved in 2006: Merrill Goozner comments on his blog, GoozNews, about the lowering of innovation in the pharma industry.
  • FDA Starts Podcasts: The FDA Commissioner, Dr. Andy von Eschenbach, has started a series of drug safety-oriented podcasts. The first one just announces the series. Go to the XML feed to subscribe.
  • ADHD Drug Warnings: The FDA is requiring all manufacturers of drugs used to treat ADHD, including Adderall, Concerta, Ritalin, and Strattera, to develop Medication Guides to warn patients about the risks of cardiovascular (sudden death, stroke, heart attack, blood pressure) and psychiatric (mania, psychosis, aggression) side effects.
  • Vyvanse releases Medication Guide: Shire's Vyvanse (lisdexamfetamine dimesylate) was listed last month (before the name was changed from Vynase) as a new ADHD drug. It is a prodrug, meaning it is metabolized into an active drug by the body. Advantages are said to be that it is once-daily and that it is less likely to be abused (ie, 4 out of 5 drug abusers prefer other stimulants to this one). It now has full approval as a Schedule II drug (for full prescribing info, see link to Label Info here.)
  • Changes in Nardil (phenelzine) Prescribing Info: added severe renal impairment or renal disease to list of contraindications; added cautions about use in diabetes; and added warning about drug interaction with guanethidine (Ismelin).
  • Changes in Cymbalta (duloxetine) Prescribing Info: a number of changes were made, though I cannot tell how substantive these were. Lilly did receive a new indication for the treatment of GAD (Generalized Anxiety Disorder) with Cymbalta.
  • Changes in Effexor XR (venlafaxine) Prescribing Info: the following was added under the Precautions section: "Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported. The possibility of these adverse events should be considered in venlafaxine-treated patients who present with progressive dyspnea, cough, or chest discomfort. Such patients should undergo a prompt medical evaluation and discontinuation of venlafaxine therapy should be considered."
  • Zimulti or Acomplia (rimonabant) review extended: This cannibinoid receptor antagonist, which is being reviewed as a weight loss drug (you guessed it... it blocks the munchies, even if you are not smoking pot), was to have a final decision on approval status on April 26. The review period has been extended to July 27. (I reported in November's update that this drug was approved in Mexico.) The latest proposed brand name is Zimulti. The hearing for this drug will be held on June 13, 2007, before the Metabolic & Endocrinologic Drugs Advisory Committee. When the background resource documents are ready, they will be found here.
  • Warning Letter: Provigil (modafinil). Cephalon got slapped for promoting its wakefulness-promoting drug (indicated for use in narcolepsy, obstructive sleep apnea, and Shift Work Sleep Disorder) by distributing a document by Dr. Kerasidis which states the drug is effective in multiple sclerosis, Parkinson's, depression, ADD, and chronic fatigue syndrome. Interesting, in that this document was provided as testimony to the Maryland Dept of Health and Mental Hygiene's Committee which is responsible for making decisions about which drugs will be placed on the Medicaid formulary list.


NeoNurseChic said...

Do they really need more warnings for nardil? Couldn't they just put "interacts with everything and no matter who you are, you probably have some risk factor" on the label and that would cover it? lol...

Took parnate for headaches...psychiatrist at the HA ctr suggested parnate because apparently it has some components that are good for attention, and I couldn't be on concerta while on the parnate. (I think? Don't remember...) I got a sinus infection. Couldn't get any doctors to tell me what I could take for the sinus symptoms. My neuro's office said, "We don't deal with infections" after I exhausted every other possibility, including asking an ER doc! Finally, l told my neuro's office that they prescribed it and nobody else will help me...they said "use saline drops". True...only thing safe at the time!

When I came off parnate and came through the required amount of weeks after being off it, I ate cheese like 10 times a day. I never knew how much I loved cheese until I couldn't eat it. I actually gained a fairly significant amount of weight when I came off it just because I couldn't get enough cheese! lol... Funny what not being allowed to have something does to it! Our hospital places very low dietary restrictions on MAOIs...the list wasn't bad - aged meats and cheeses, red wine, foreign and all tap beers, banana peels (who eats those?), and a few other random things. The p-doc at the center even said I could drink hard liquor if I wanted...which led my neuro to ask, "So you like to drink hard liquor? Do you do this often?" ha.....

I think I have a story with just about every class of drug! Too bad none of them have helped the headaches....maybe someday! ;)

Anonymous said...

What is the real deal with provigial? My psychiatrist put me on it--I have fibromyalgia and sleep 10 to 14 hours per day if left alone. I fall asleep driving. Like on the freeway driving

My primary won't write it for me and won't discuss it and my rheumatologist said "I don't like it but do what you want". If you are not comfortable "or the lawyers aren't" with answering a question is there a decent site to get information from?

I'm a psychiatric social worker with 20 years in the field and 2 years acute care hospital experience so I am a moderately informed consumer.

Anonymous said...

Google Answers put together an interesting analysis of the number of NDAs (new drug applications) that come into FDA each year, and the associated costs:
FDA New Drug Applications

It gives some interesting perspective to a story like this.