Drugs/Medical Archive

Will Generic Accutane Spawn more Lawsuits?

March 30th, 2010. By janem

Accutane may be buried but the generic form, isotretinoin, is alive and may be hurting. Roche Holding pulled Accutane off the market in June 2009, about 15 years too late for countless victims of Accutane injury. Since its approval in 1984, the drug had been linked to psychological changes, suicidal behavior, auto-immune disease, central nervous system problems, birth defects and most notably,  inflammatory bowel disease (IBD).

But Roche didn’t discontinue manufacturing its blockbuster drug for safety reasons. Instead it had to do with legal and economic issues: generic competitors reduced the drug’s market share to less than 3 percent — Accutane’s departure leaves Claravis (Teva/Barr) with 54.8 percent of the isotretinoin market, followed by Amnesteem (Mylan/GenPharm) and Sotret (Ranbaxy), each with 22.8 percent. And Roche has paid out plenty in personal injury lawsuits. (To date, juries have awarded more than $33 million to patients who blame Accutane for their IBD.)

So the pharmaceutical industry spawns other generic forms of Accutane, called isotretinoin, priced from 10 percent to 65 percent (Sotret) less than Accutane. That may be good news for some lawyers–one attorney has filed more than 100 similar cases against makers of generic isotretinoin–but bad news for teens and young adults who (might) weigh the odds and decide they would rather develop IBD than suffer with acne and hey, the medication is now so much more affordable. Granted, acne can be debilitating emotionally. It can cause high levels of anxiety or depression during teen years, reason enough to disregard more dangerous side effects such as IBD.

The dermatology jury isn’t out on isotretinoin, yet. One dermatologist says that pharmacists mistakenly believe all isotretinoin products are therapeutically equivalent and they prescribe the generic brand because their patients wanted a cheaper product. “Dermatologists were essentially forced by patients to abandon [Accutane],” says Dr. Taub, who believes that “bioavailability from patient to patient differs so much more with generic isotretinoin than with Accutane.” Dermatologist Ty Owen Hanson says Claravis didn’t seem to work for his patients. “It was almost like patients were taking a placebo.”

Another dermatologist, Dr Webester, says Accutane and its generics possess identical pharmacokinetic curves. Dr. Feldman says he sees no difference between Accutane and its generics and doesn’t know which generics his patients get. Generally dermatologists stopped prescribing Accutane when the Roche reps stopped coming by with free samples, about the same time the generic isotretinoin debuted. More than two decades after Accutane’s introduction, it still cost up to $1,200 monthly, versus $600 to $900 for generics.

So the end of  Roche’s blockbuster drug paves the way for other drug companies to cash  in.  But will generic manufacturers remain in the marketplace if they begin to get slapped with personal injury lawsuits? After all, there’s only one way to spell isotretinoin…

Tags: Accutane, Add new tag, defective drugs, Isotretinoin, Roche
Posted in Drugs/Medical | 3 Comments »

Medical Marijuana Catch-22: You’re Fired

March 24th, 2010. By AbiK

How in hell do the fourteen states where it’s legal—yes, LEGAL—to use marijuana for medical reasons have such a progressive law that, on the flip side, opens the door for employers to fire medical marijuana card-carrying employees who test positive for marijuana use?

According to a cnn.com article, Keith Stroup, who’s on the legal counsel team for the National Organization for the Reform of Marijuana Laws, says he gets around “300 emails and phone calls a year from medical marijuana who have been fired or had job offers rescinded because of a failed drug test.” 

Stroup goes on to say, “Usually they talk about how they have lost their job and I tell them there’s not a thing they can do about it.”

True, in most at-will employment states an employee can be fired for any reason—except for those reasons that put the employee in a federally protected class—such as race, gender, and religion.

But medical marijuana-use employees are not a federally protected class. So employers pretty much Read the rest of this entry »

Tags: Discrimination, Employment, Labor Law, Marijuana, Medical Marijuana
Posted in Discrimination, Drugs/Medical, Emerging Issues, Employment | 8 Comments »

Your First Clue Something’s Wrong with Fosamax

March 18th, 2010. By AbiK

Yup. There’s your very first clue. The website—usually chock-full of bright branding colors (Fosamax green and yellow, the colors of grass, trees and sunshine…ahhh) and salt-of-the-earth salt-and-pepper haired folks enjoying precious moments with the grandkids or out there gardening—all smiles because they’re taking Fosamax and feelin’ fine. No osteoporosis worries there.

Now, no, I can’t say for sure that the “official” Fosamax site has gone to straight black type on white because there are any problems… but I’m guessing the site’s “not currently available” for reasons beyond a pricing analysis going on over in the marketing department.

Yup. A non-existent website. It’s a marketer’s nightmare. A PR person’s problem to manage. And it’s your first clue that maybe, just maybe, something’s amiss…

(psssst—if you haven’t been clued in yet, read on…)

Tags: Fosamax, Osteoporosis
Posted in Drugs/Medical | No Comments »

SJS on Discovery Health Mystery Diagnosis

March 15th, 2010. By AbiK

Imagine thinking your child—as an infant—has a bad case of chicken pox only to find out that it’s not chicken pox but a very bad reaction to some medication (in this instance, an anti-convulsant). Then imagine finding out that the reaction has a name: Stevens Johnson Syndrome (SJS). And it can bring on a number of life-threatening symptoms in addition to leaving scars and medical conditions that can last a lifetime.

That’s what happened when Julie McCawley, now 16, was an infant and was admitted to a hospital for what was seemingly a very bad case of chicken pox. Covered with burn-like blisters, her eyes began to swell shut and she was finally diagnosed with SJS as the result of taking an anti-convulsant.

While Julie is fortunate to be alive, she has since endured 13 surgeries to counter the lasting effects of SJS and she is now blind in her right eye and photophobic. She also carries the scars from the blisters that once covered her body. 

Discovery Health’s Mystery Diagnosis will be airing a segment on Julie’s experience—it’s a program that all parents should aim to watch to become more aware of SJS, which can be difficult to diagnose—and according to Julie’s mother, Jean, that’s simply because “so few doctors are familiar with SJS”.

The Discovery Health Mystery Diagnosis program on SJS will air on March 22—check your local listings for times and channels.

Tags: Discovery Health, SJS, Stevens Johnson Syndrome
Posted in Drugs/Medical | 2 Comments »

First Zits, then Accutane, then IBD, then Kidney Stones?

March 12th, 2010. By AbiK

Remember that  book, “Because a Little Bug went Ka-CHOO!”–the one where there’s this tiny little sneeze that leads to a chain reaction that winds up with a huge circus marching through town? Yeah, that one. Well, this article from over at HealthDayNews this week kind of reminds me of that book, only not in a warm ‘n fuzzy kind of way.

The article is about Inflammatory Bowel Disease (IBD)—which has been linked to the anti-acne prescription medication Accutane. And it seems IBD can affect more (actual quote is “much more”) than just your digestive system.

The National Women’s Health Information Center states that IBD can actually contribute to the following health problems:

• Arthritis and pain in the joints
• Fractures and weakening of the bones
• Problems with the eye, including inflammation
• An inflamed liver
• Kidney stones or gallstones
• Skin ulcers or a red, bumpy rash
• Problems with growth and delayed onset of puberty in children and teens
• Problems with the lungs (though such cases are rare)

The article just helps to highlight that IBD is a serious disease that can not only wreak havoc on the intestines, but also a number of other areas. And, as such, careful consideration should be taken when considering anti-acne treatments that use the drug, isotretinoin—Accutane, Amnesteem, Claravis or Sotret. And, as we previously posted, parents should be aware that a number of these drugs are available online, sans prescription.

Tags: Accutane, IBD, Isotretinoin
Posted in Drugs/Medical | No Comments »