FDA Approves Generic Ambien, Fosamax, Coreg and more

Filed Under (Medicine) by User ImageCris Harshman on 04-03-2008

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I was wondering why I haven’t seen any Ambien commercials lately. According to the FDA,

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Here’s a list of some of the generic drugs approved by the FDA so far this year:

  • Alendronate Sodium Tablets (Fosamax)
    Used for: Treating and preventing types of osteoporosis
    Originally marketed as: Fosamax, by Merck & Co.
    Date approved: Feb. 6, 2008
  • Carvedilol Tablets (Coreg)
    Used for: Treating hypertension and heart failure
    Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
    Date approved: Sept. 5, 2007
  • Cetirizine HCl Tablets (Zyrtec)
    Used for: Treating symptoms of allergies
    Originally marketed as: Zyrtec, by Pfizer
    Date approved: Dec.12, 2007
  • Granisetron Tablets (Kytril)
    Used for: Preventing nausea and vomiting related to chemotherapy and radiation
    Originally marketed as: Kytril, by Roche
    Date approved: Dec. 31, 2007
  • Oxcarbazepine Tablets (Trileptal)
    Used for: Treating certain kinds of seizures and epilepsy
    Originally marketed as: Trileptal, by Novartis
    Date approved: Oct. 9, 2007
  • Pravastatin Sodium Tablets (Pravachol)
    Used for: Treating elevated cholesterol and preventing coronary events.
    Originally marketed as: Pravachol, by Bristol-Myers Squibb
    Date approved: Apr. 23, 2007
  • Zolpidem Tartrate Tablets (Ambien)
    Used for: Treating insomnia
    Originally marketed as: Ambien, by Sanofi Aventis
    Date approved: Apr. 23, 2007

For more information, the FDA’s Office of Generic Drugs maintains a frequently-updated list of generic drug approvals.

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Buying Ambien online? FDA says you’re getting an anti-psychotic.

Filed Under (Medicine) by User ImageCris Harshman on 16-02-2007

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The FDA released a news alert today about purchasing Ambien and other drugs over the Internet.  Apparently, some people who order these drugs are instead receiving Haloperidol, an anti-psychotic drug used to control symptoms of schizophrenia and other neurological disorders:

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug…  Haloperidol can cause muscle stiffness and spasms, agitation, and sedation…  FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia.

More at the FDA’s site.

Honestly, I have no idea why the hell someone would buy prescription meds off the Internet anyway.  Why do people feel they have the knowledge and education to self-medicate??  Personally, I think a lot has to do with advertisements - now that pharmaceuticals advertise directly to consumers, they feel empowered and emotionally hooked.  They see fluttery luminescent butterflies, cholesterol scores dropping and couples holding hands in floating bathtubs.  They hear a list of “common side effects include” and feel empowered to make the decision for themselves to balance side effects versus the perceived benefits.

“Ask your doctor for Requip.”  In years past, your doctor would spend a good half an hour doing a basic yearly exam, taking time to diagnose and treat your body as a whole, not just the symptoms you display.  Now, people see commercials, decide for themselves they suffer from all kinds of ailments, and doctors who are tired of fighting their patients simply fill out the prescription.  Soon you’ll be paying your $68 doctor’s visit fee to your television.

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Does Ambien makes you fat and cross-dress?

Filed Under (Medicine) by User ImageCris Harshman on 07-02-2007

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According to this news article in the Herald Sun, health officials (I’m assuming in Australia) are alerting doctors to some odd side affects of taking an insomnia drug generically known as Zolpidem - or, as we know it on this side of the pond, Ambien.  Forget sleepwalking - some people are reportedly sleepeating, like a woman who “mysteriously” gained more than 50lbs over seven months and was finally discovered eating out of the fridge, fast asleep.  And if that’s not bad enough:

The tales match another media report last year of a Sydney man who had taken two Stilnox tablets at home and later woke to find himself lying on a woman’s couch wearing a dress.

And this is what the Air Force (and others) are handing out to soldiers as “pharmacological fatigue countermeasures?”  If a study is undertaken to verify these reports, I’d love to see the military participate.  Makes me wonder if reports I occasionally hear about returning Iraqi soldiers committing out-of-character acts like suicide and domestic violence are perhaps related to these “pharmacological fatigue countermeasures.”

As the Adverse Drug Reactions Advisory Committee (ADRAC) stated:

…prescribers [should] be alert to the fact that zolpidem may be “associated with distressing neurological or psychiatric reactions”.

Indeed.  I’d certainly say a drug causing people to wake up in the midst of cross-dressing and binge-eating to have “distressing neurological or psychiatric reactions.”

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