Sunday, January 21, 2007

FDA Drugs: November 2006

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

Just a quick list of psychiatry-relevant FDA and related notices...
  • More Ambien (zolpidem) generics (and here) get tentative approval. Sanofi's patent expired on Oct 21, 2006, but they triggered an automatic 6-month extension by applying for pediatric use. We should start hearing about generic Ambien around April or May. The first approved generic manufacturer gets an automatic 6-month exclusivity before the flood gates open up, and other manufacturers can get into the game. There are about a dozen manufacturers all lined up for tentative approval.

  • Phase I results promising for NGX426. NGX424 gets coverted in the body to tezampanel, an AMPA/kainate receptor antagonist, which makes it a non-narcotic pain medicine. The company, TorreyPines, seems to be looking at indications for migraines and neuropathic pain, though this class of drug may be useful on epilepsy and anxiety, as well.

  • Drugs to turn on specific genes. This is one of the new holy grails. As described in the linked PNAS article, using RNA interference techniques, you make a little piece of double-stranded RNA (dsRNA) that is designed to bind to a specific gene, say, the gene that contains the instructions for making amyloid precursor protein (APP), which is involved in causing Alzheimer's dementia, or maybe the gene that codes for a particular variant of the CETP protein, which has been associated with increased longevity. According the article, sometimes this technique will silence a gene, and sometimes it will crank up the volume. Drugs of the future would be used to selectively turn on, off, up, down genes, like fiddling with 100,000 dials on a huge mixing board, trying to get just the right mix. A fascinating, but scary, proposition.

  • Mirapex (pramipexole) approved (label .pdf) for Restless Legs Syndrome. This is old news now, thanks to the marketing blitz on this indication.

  • Generic Zyprexa (olanzapine) gets tentative approval. There are now 5 companies with approved versions of generic Zyprexa, waiting to launch when either Lilly's patent expires (2011) or someone successfully challenges their patent application (now in process).

  • Rimonabant (brands Acomplia or Zimulti) approved in Mexico. The sexy new diet drug is already approved in Europe, and is now on our shores. Rimonabant is a CB1 cannibinoid receptor antagonist, so it will also block the munchies from smoking marijuana. Sanofi Aventis has already submitted a new drug application to the U.S. FDA, followed by a resubmission in October.

  • Seroquel marketing warning letter. AstraZeneca received an FDA letter warning that they violated the rules by underemphasizing the risk of diabetes with Seroquel in a piece of marketing material. They also failed to note some other risks.

  • Warning: Tamiflu side effects - delirium, self-injury. Roche and FDA sent out notification letters warning of reports about self-injury and delirium occurring in people, especially children, who have the flu and take Tamiflu. They note that these reactions may also occur from the flu itself.

  • Warning: Methadone side effects - cardiac, breathing, death. FDA put out a public health advisory warning of "reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes)."
Search the FDA's "Orange Book" for more drug data.

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NeoNurseChic said...

Good ones! I hadn't heard of tezampanel, so that's exciting. Gives me hope that maybe retrying stuff I already failed isn't all there is left for me. Guess we'll see. The methadone warning seems like a "duh..." Generic drug wars....rough and tough stuff. Glaxo still has a death grip on imitrex and keeps finding all kinds of ways to keep their patent...trexima, OTC trex in England, etc. That drug bankrupts people who truly need it, but they're so greedy that they'll research new patent extensions until the end of time on it...

Take care!
Carrie :)

Sarebear said...

Holy COW on the genes thing . . . eeeee!

It does sound scary, although promising in certain ways, too.

It also seems to me, being such a . . . well, a threshold in medicine, to step over, that all sorts of unforeseen consequences of doing this sort of thing could and may happen. Hopefully though, they'll get a handle on those things . . .

It gives me a teeny tiny bit of hope, that they might be able to mitigate bipolar and such, at least from the genetic basis (what's the plural of basis, bases? lol) of it. There's much more to bipolar than genetics, but improve it from any angle you can, I say. But then, I would.

(excepting creating embryos for stem cell research; use the existing lines, or those that would be discarded from fertility procedures done with women/couples) Yeah that's a whole nother debate, but since I said improve it from any angle you can, I felt I better state that exception. I'm rather conservative, anyway. That's just for ME; I'm not meaning to start a debate on that, anyway.

There's enough potential controversy just in the gene drugs, anyhoo, lol.

Midwife with a Knife said...

Pediatric ambien? Wow. I guess I never knew that kids get insomnia.

Sarebear said...

They'll get whatever the drug companies say they get.

yeah, that's a bit disingenuous, but still.

DrivingMissMolly said...


When I was a kid, kindergarten or so and onward, I had insomnia. I'm not sure how 'normal' or 'abnormal' that is but I was up all night sometimes. I remember listening to the breathing sounds of everyone in the family and reading my children's bible until the sun rose.

In retrospect I wonder if my insomnia was caused by my asthma or by medicines I took for it.

I also sleepwalked and had nightmares and nighterrors.

I kind of would like a sleep study just to see if something came up.


Anonymous said...

I am writing on behalf of the victims and those yet to be victims of methadone. I have come together with many other families throughout the United States who have lost loved ones to methadone.

We are asking government agencies to enact stricter guidelines in prescribing methadone for any reason. It must be mandatory that all doctors be certified and trained in the pharmacology of methadone; inpatient stays must be required during induction to methadone; all staff be extensively trained in monitoring methadone patients for symptoms of toxicity. Clinic patients should be tested for legal and illegal drugs that are taken with methadone to get “ hi gh” of experience “euphoria” such as benzodiazepines, alcohol, cocaine, heroin ect… and face severe consequences / mandatory detoxification from methadone program when presenting inebriated at clinic, clinic should also document such activity as well as prevent client from driving. Take home doses for all patients receiving methadone should be eliminated thus preventing the risk of diversion or precautions such as pill safe should be implemented.

Current statistics show that nearly 4000 people a year die from methadone. These deaths are mostly happening to pain management and detoxification patients wit hi n the first 10 days of taking initial dose. Most of these deaths are related to methadone prescribed with other medications that react as additives with methadone. Diversion of methadone is a serious problem because it lands t hi s most deadly drug on streets. Statistics also state that methadone is contributing to more deaths nationwide then heroine and cocaine.

The government did take notice after the 2003 record number of deaths associated with methadone and the Bush administration responded by gathering the top experts on drug overdoses, doctors, researchers, and medical examiners, as well as representatives from the federal Drug Enforcement Administration, Food and Drug Administration, and Substance Abuse and Mental Health Association. Finn and Tuckwiller (2006) report that “the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone”. Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. My question is why hasn't a team of independent researchers not funded by pharmaceutical companies; a person or group of people that stand to gain no financial benefit on the outcome of the studies been hired to conduct the research? Finn and Tuckwiller (2006) report that “the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone”. Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. On the forum associated with his website several of the clinic participants speak of diverting, misusing, stockpiling, selling, and potentiating methadone and other prescription drugs.

This methadone epidemic and deaths associated with it are not going away. It's only getting worse; I get contacted by families on a daily basis who have lost someone to this drug. At what point do we value human life over the convenience of others? Methadone patients, whether they are pain or clinic pose a risk to themselves and society as a whole if they are not monitored, dosed, and assessed correctly. Clinic patients getting into cars after being dosed who are using benzodiazepines, alcohol, or other opiates are killing innocent people on the road. This type of harm reduction is not saving lives it’s taking them. The government cannot continue to be a legal drug dealer in order for its citizens to “behave”. Many MMT patients claim that they have been able to maintain sobriety for long periods of time (several years) but are unhappy and depressed therefore seek out MMT and describe the "high" they get from this that makes they happy. Endorphin Deficiency is another "off-label" use of methadone. I have yet to be able to find this "diagnosis" listed in the DSM IV but I'm am sure they a large percentage of the population suffer from this as endorphin deficiency precipitated not only by opiate abuse but also eating disorders, ADHD, low levels of neurotransmitter GABA, PMS, stress, MS, depression etc....
I know the rules are in place for the clinics but they are NOT being followed. Patients sell take homes outside the clinics. In one news article a man died in the parking lot of a clinic after taking his brothers take home. This drug is too dangerous to be allowed in medicine cabinets! There is A LOT of money to be made from methadone but what expense is that money being made at? When do the risks outweigh the benefits of this drug? How many more people must die before changes are made that actually save lives?

On June 24th 2006 I lost my fiancé (Ron) to t hi s deadly drug prescribed by a physician with a combination of other medications that acted as additives to the Methadone. He had knee surgery and became addicted to the percocet he was prescribed. He checked hi mself into Greenleaf in Valdosta , GA for detoxification. Upon entering the facility he was drug tested and did not come up positive for opiates (he had stopped taking the percocet 4 days before entering the facility). On the fourth day in detox he died sometime between 2am and 1pm in the afternoon (he was never checked on in all of those hours). The night before he died he was complaining of migraines and vomiting, apparently the staff thought he was still experiencing withdrawals and was not concerned about these symptoms. The symptoms of methadone toxicity mimic withdrawal symptoms physicians and staff must be very cognizant of the complex properties and metabolization of methadone. There were many errors made in my fiancé’s death including the fact that he was given numerous amounts of additive medications such as benzodiazepines. He had only been taking percocet for about 4 months and according to the DSM IV he wouldn’t be an appropriate candidate methadone maintenance treatment.

It doesn't matter specific reasons for taking methadone but what does matter is that t hi s medication is deadly and physicians need to more prudent in prescribing it as well as monitoring their patients w hi le beginning treatment of any kind using Methadone. I'm not sure if Ron was given methadone for the sole purpose for detoxification from opiates or if it was a combination of pain relief associated with numerous surgeries and opiate addiction. Methadone is difficult to properly dose no matter what reason it's being used for and primarily relies on the patient’s indications of how they feel (assumedly they are being monitored). There are ways to make the administration of methadone safer, it's just a matter of putting the focus on t hi s drug and the deadly consequences when administered incorrectly or not monitored.

Many people are dying unnecessarily at the hands of the physicians they turn to for help. Methadone deaths are rising throughout the country. Ron was 32 years old and has 2 c hi ldren from a previous marriage that now do not have a father.

I'm also providing you a link to a website I created in hi s memory to give a more human touch to t hi s email.