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Good news, generic OxyContin is now approved

Posted by BrianG on 3/24/04 at 21:13 (147704)

The FDA announced today that it has approved generic versions for the long acting pain med, Oxycontin. This will be welcome news for chronic pain patients with little, or no insurance. They will also work on making it not so popular to the dug abusers. Last year I read something about this. They were thinking of adding an ingredient, that would kill the high, if the tablet was crushed, or powdered. Actually I don't know what took so long, as the Morphine version of MS Contin, has been available for a while now.

Taken a directed, it is a wonderful long acting pain med, sometimes the only thing that will eliminate chronic pain.
Over 10 MILLION Americans suffer from chronic pain!


Cut & Pasted from the FDA website:

FDA Statement
March 23, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Statement on Generic Oxycodone Hydrochloride Extended Release Tablets
The Food and Drug Administration today released the following statement on its approval of generic oxycodone hydrochloride extended-release tablets:
Oxycodone hydrochloride extended-release products, such as OxyContin and its generic versions, are important options for the management of moderate-to-severe chronic pain, such as that associated with cancer and various other illnesses. FDA's approval of two generic oxycodone hydrochloride products should make this safe and effective medicine available at a lower cost to patients suffering from moderate to severe chronic pain.

At the same time, FDA recognizes that oxycodone extended-release tablets present a potential for abuse, misuse, and diversion. That is why FDA has secured the agreement of the manufacturers of the generic products to have in place, prior to marketing, risk management plans that are consistent with the innovator product's plan.
Decades of experience with generic drug approvals suggest that, when the first generic versions of an innovator drug reach the market, the use of that drug does not increase overall. Rather, demand tends to remain steady, with an increasing proportion of market share being held by the generic versions.

Earlier this month, the Office of National Drug Control Policy, the DEA, and FDA announced a coordinated strategy to confront the illegal diversion and abuse of prescription drugs. This coordinated strategy includes:
Careful consideration of labeling and commercial promotion of opiate drug products;
Ensuring wider dissemination of education and training on appropriate pain management and opioid treatment procedures for physicians authorized to prescribe controlled substances;
Increasing the number of state Prescription Monitoring Programs, which detect suspicious prescriptions and individuals redeeming prescriptions from multiple physicians ('doctor shopping') to identify abusers; and
Using web crawler/data mining technology to identify, investigate and prosecute 'pill mills' - Internet pharmacies that provide controlled substances illegally
Today's announcement incorporates education of medical professionals and consumers, outreach to businesses involved in Internet commerce, pharmaceutical manufacturers, and pharmacies, as well as increased investigation and enforcement activities.
When used correctly, opioids play a very important role in the management of pain. FDA's job is to maximize the potential benefits that patients receive from these drugs, while, at the same time, minimizing the risks associated with these products. FDA takes its responsibility in meeting this challenge very seriously.

In approving these generic products, FDA is seeking to balance the need for effective pain management therapies -- for the more than 10 million Americans who suffer from chronic pain -- with the prevention of misuse, abuse, and diversion of prescription drugs.

Re: Be thankfull, if you live in the US

BrianG on 3/25/04 at 08:15 (147733)

Cut & Pasted from the BC / BS web site:

Many Europeans Don't Get Help for Chronic Pain

THURSDAY, March 18 (HealthDayNews) -- Half the people with musculoskeletal pain in Europe -- about 100 million individuals -- endure chronic pain because they don't receive treatment for their condition, says a study in the Annals of the Rheumatic Diseases.

Researchers conducted interviews with about 6,000 people with musculoskeletal pain and about 1,500 doctors in eight European countries -- England, France, Germany, Ireland, Italy, Spain, Sweden, and Switzerland.

The survey revealed that management of musculoskeletal pain differed little between the countries and family doctors felt they did a good job of managing the condition. However, their patients didn't always share that view.
About one in four patients with musculoskeletal pain said they didn't seek medical help, even though between 60 percent and 75 percent of the patients surveyed said they suffered pain on a constant or daily basis, to the point that it limited routine activities.

Patients who did seek medical help often waited several months or years before doing so, the survey found. About half the patients who had consulted a doctor about musculoskeletal pain were not currently being treated for their pain.

The doctors in the survey said they offered all patients some form of treatment for their pain. And nearly all the doctors said they were trying to improve quality of life for those patients.

Non-steroidal anti inflammatory drugs (NSAIDs) were the most common prescription drugs offered by the doctors to people with musculoskeletal pain. German doctors were more likely to recommend exercise, physiotherapy, herbal medicine and acupuncture to patients than doctors in the other countries.

More information
The Arthritis Foundation has information about osteoarthritis.
SOURCE: Annals of the Rheumatic Diseases, news release, March 17, 2004

Re: Good news, generic OxyContin is now approved

Suzanne D. on 3/25/04 at 17:36 (147792)

That does sound promising, Brian! Thanks for always keeping us informed of the latest research concerning pain medicines. Less costly medicines for those who need them, plus less popularity with drug abusers, sounds like a winning combination.

Hope you're doing well these days!
Suzanne :)

Re: Good news, generic OxyContin is now approved

Kathy G on 3/26/04 at 13:42 (147857)

If the generic works for the people presently on OxyContin, then it's good news for them. If it doesn't and their insurance companies won't cover the brand name, it's bad news. Too often people who are established with a brand name honestly don't get the same results with a generic. It's not as common now as it used to be when generics were first being introduced but it is one area where insurance companies give the patient a hard time. Sometimes if their doctor appeals it for them, the insurance company gives in but often times it doesn't. So that's why generics can be a blessing or a curse.

As for the information about pain relief abroad, it is certainly one of the times that, despite all our complaining, we do have the best health care in the world.

Re: Good news, generic OxyContin is now approved

Kathy G on 3/26/04 at 13:44 (147859)

I'm just like Suzanne. Why don't I edit things before I hit the submit button? I meant to say that despite our complaining, we should be thankful that we have the best healthcare in the world! DUH!#-o

Re: Good news, generic OxyContin is now approved

Suzanne D. on 3/26/04 at 17:21 (147885)

Kathy, that is a valid point you make. I used to be plagued with recurrent bladder infections and found out the hard way that Macrodantin was the only medicine that would take care of the problem. The generics for that drug simply were not effective for me.

My uncle is a retired pharmacist, and he heard me talking during a visit about how I just couldn't get over the infection, and he asked to see my bottle of medicine. He said to insist on the Macrodantin as the generic was not as theraputic. A few years later, I had another infection and told the pharmacist that I did not want a substitution. He told me that there was a new list (at that time) of drugs that could not be substituted by a generic unless specified by the doctor, and Macrodantin was on that list.

The world of medicine is certainly a complex one!

Suzanne :)

Re: Good news, generic OxyContin is now approved

BrianG on 3/26/04 at 22:32 (147901)

I have to agree about the quality of the generics. I take one med, that used to be brand, it's now generic. Of course my insurance company made me switch to the generic. I could tell right away it was not as effective as the Brand, but learned to live with it. What is worse is that the pill's outside covering is much more 'crumbley' than the brand name. I really have to be careful, when carring my day's dosage with me.

I'll put up with it though, knowing that some others will be afford to buy the med, in the generic form, rather than
going without.


Re: Be thankfull, if you live in the US

Ed Davis, DPM on 3/27/04 at 11:55 (147948)

What took the FDA so long? Don't get me started on what I think of the FDA -- it will get me thrown off this board ;)

Re: Good news, generic OxyContin is now approved

Ed Davis, DPM on 3/27/04 at 11:58 (147949)

Kathy and Brian:
Many generics are actually produced by major drug companies and are of high quality. It is good to ASK the pharmacist about the manufacturer (manufacturer is often on the label). Some pharmacies try to maximize profit by going to a second tier manufacturer to maximize their profits when a better, more reputable generic is available -- keep an eye out for this.

Re: Good news, generic OxyContin is now approved

john h on 3/29/04 at 09:37 (148045)

Brian: How much does the Oxy reduce your pain level? Example: from a 8 to a 2. I have 4-5 capsules left over from my kidney stone problem 4 years ago. At that time I was in so much pain I cannot remember if they helped or not.