Posts Tagged ‘ Accutane ’

Will Generic Accutane Spawn more Lawsuits?

March 30th, 2010. By janem

accu Will Generic Accutane Spawn more Lawsuits? 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 | 32003 Comments »2010-03-30+17%3A23%3A20janem

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

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 | 2981No Comments »2010-03-12+15%3A23%3A24AbiK

Parents: Is your Kid on Isotretinoin? (aka Accutane)

March 3rd, 2010. By AbiK

accutane Parents: Is your Kid on Isotretinoin? (aka Accutane) Yes, Roche stopped selling acne drug Accutane back in June 2009. But that was a decision made by that company—not the FDA. And, that decision was made (insert raised eyebrow here) for “business reasons”—not for any safety issues. Ahh, but here’s the thing… those “business reasons” included competition from generics. And guess what? You can still get those generics. Other than Accutane, isotretinoin is sold as Sotret, Claravis and Amnesteem.

I imagine a number of parents of acne-ridden teens breathed a sigh of relief when Roche stopped marketing Accutane. After all, what parent wants to consider putting their teenage daughter on some form of guaranteed contraception in order to be put on a drug proven to cause birth defects just so they can clear up their zits? Beyond that, reports of depression, suicidal thoughts, possible gastrointestinal problems—and labelling that also warns of a potential sudden decrease in night vision (mom, can I have the keys to the car?)—don’t exactly add up to a drug you want your child on.

But let’s face it, internet-savvy teens have no problem beating the system and finding ways to order isotretinoin online—particularly when the promise of clear skin in on the line. Enter a recent study published in the Journal of American Academy of Dermatology (January 2010) titled Availability of Oral Isotretinoin and Terbinafine on the Internet.

The study, by Jason P. Lott and Carrie L. Kovarik, MD, looks at the proliferation of websites that sell certain medications without a prescription—specifically dermatologic medications. In their study of websites readily found via Google search, they categorized the websites into four groups: Illicit Commercial (those that offered purchase without a prescription); Legitimate Commercial (US licensed pharmacies requiring prescriptions); Informational (those offering only information, not sale); and Other for those not fitting into the other above categories.

What did they find? For their search on “no prescription Accutane”, 66% of the sites returned on search were categorized as Illicit Commercial. Translation: you could buy Accutane from them without a prescription.

Lott and Kovarik state that they did not go through and actually purchase any oral isotretinoin via the sites they studied—so it’s not certain that the medications would actually be received or if they would be authentic. That said, the authors of the study indicate that the US Government Accounting Office (GAO) reports that 94% of all online opioid purchases result in delivery of the drugs as advertised.

If the GAO report is true, I’d be checking my kid’s backpack.

Tags: Accutane, Acne Medication, Amnesteem, Claravis, Isotretinoin, Sotret
Posted in Drugs/Medical, Emerging Issues | 2879No Comments »2010-03-03+19%3A46%3A13AbiK