Roxane Pharmaceuticals has just released a new generic for Subutex, It is a much cheaper alternative to the expensive brand name. It comes in 8mg and 2mg like the brand name. Despite the rumors and fears it DOES NOT contain talc as an inactive filler, actually the formula is almost identical to the brand name, The possibility of it containing Talc like it’s UK counterpart caused quite a stir on the internet and with doctors everywhere.

New Generic Subutex from Roxane Pharmaceuticals (2 8mg pills)

To catch you up on what happened with the Talc scare, before the generic was even approved by the FDA, doctors got together and petitioned it because “Talc” could be used as a filler. Reckitt Benkiser (Brand Name) also sent the FDA a citizen petition in hopes of holding up approval, in the petition the main concern they held as reason to hold up the generic was:

“The concern is the presents of talc, a binding agent used instead of the more expensive cornstarch process used by the branded product. Their concern is that when misused by injection or inhalation the talc which is a mineral and not biodegradable, like cornstarch, can cause severe complications and in some cases death.”  .. Read the Full Petition Here

The FDA denied this petition:

Here’s some of the FDA’s response to the petition.

“Subutex and Suboxone have combined labeling, as they are intended to be used in sequence by patients. The labeling of Subutex and Suboxone instructs prescribers to initiate treatment with supervised administration . The labeling makes clear that Subutex, which does not contain naloxone, should be limited to supervised use wherever possible As patients progress, Suboxone is intended to be prescribed for take-home use in appropriately limited quantities .” ..Read the Full Response Here

Unfortunately this is not true, many people are prescribed a months supply of Subutex to take home. If this pill contained Talc and someone decided to abuse it, or any other prescription drug containing talc, by crushing it up and then “snorting”, “shooting”, or “smoking” it, they are at risk of getting “Pulmonary Talcosis”. Which is an incurable disease that will destroy that persons quality of life. Talcosis usually occurs when small Talc particles enter the bloodstream at a much greater particle diameter then would be from regular inhalation. Only particles lower than 10um will actually make it to the lungs when inhaled through the air during our everyday lives. Short-term exposure to talc in the air is not as dangerous for this reason. But when these big particles enter the blood from an IV, they get trapped in the lungs. Talc particles are very similar to asbestos and cause a very similar diseases. Which is why it is unsafe to use Talc in prescription drugs, even more so for drugs that are made for people with substance abuse history. If the intent is to discourage people from abusing the pharmaceutical, i got 3 words for you… “Harm Reduction Approach”. Nobody should have to suffer for the rest of their life because they snorted a pill. Not to mention the majority of people that abuse these drugs wouldn’t be the wiser of it’s inactive ingredients. They wouldn’t even know what talc is. Reckitt Benkiser, the manufacturer or the brand name Suboxone/Subutex had a simple solution… Nalaxone. Which discourages everyone from abusing Suboxone due to it’s ability to precipitate instant withdrawals.  I don’t understand how mainly the drugs that are classified as narcotics, and have the potential to be abused… are the ones with Talc. I could understand if it was in a hormone pill or in birth control or antihistamine’s … who would want to snort/IV those? The reason Talc is usually used in generics is because it is much cheaper than the safer, biodegradable, cornstarch alternative. At what cost? Sometimes I really think they are just trying to kill us off.

So as you might imagine this revelation caused a big uproar on drug addict forums everywhere. Then posts started appearing claiming that there was a mistake:

“You’re right about the Roxane product not containing talc. According to their information it contains cornstarch as the binder just like the branded medication. I think when the doctors objected to the use of talc in their FDA petition, they referenced a generic formulation used overseas and not knowing the Roxane formulation at that time, feared it might be used here as well, but so far that’s not the case.”

“Even though the FDA did not mandate the “no talc” clause for generic Subutex, they knew that either way their medication will be abused. So Roxane chose not to put it in their preparation of Subutex; it is being socially responsible. Just like when Purdue took the 160mg OC off of the market. Too many opiate nieve folks were dying because they took something they did not have the tolerance to take.”

So now we know that Roxane Laboratories took it upon themselves to play it safe at potentially, the cost of profit. This surely will be rewarded by the consumers and community.

More Information about the Subutex Generic:

Roxane Subutex Info

Bioequiclancy

FDA Info

More Information about Talcosis in drug addicts:

Occupational Health guideline for Talc (Non-Asbestos Form)

Successful lung transplantation for talcosis secondary to intravenous abuse of oral drug

Talcosis of Unusually Rapid Development

Talcosis in HIV-positive Drug Addict

A 44-yr-old male with progressive dyspnoea and dry cough

Foreign body granulomatosis in intravenous drug addicts in Hong Kong

Talc: Understanding it’s Manifestations in the Chest

More on Talc:

Talc, is a mineral composed of hydrated magnesium silicate, it is used in many industries such as paper making, plastic, paint and coatings, rubber, food, electric cable, pharmaceuticals, cosmetics, ceramics, etc. It is known to be used in some forms of Ridilin, Methedone and various other pharmaceuticals and is VERY dangerous. Talc Processing eliminates a number of trace minerals from the talc, but does not separate minute fibers which are very similar to asbestos. Talc particles have been shown to cause tumors in the ovaries and lungs of cancer victims. For the last 30 years, scientists have closely scrutinized talc particles and found dangerous similarities to asbestos. Responding to this evidence in 1973, the FDA drafted a resolution that would limit the amount of asbestos-like fibers in cosmetic grade talc. However, no ruling has ever been made and today, cosmetic grade talc remains non-regulated by the federal government. This inaction ignores a 1993 National Toxicology Program report which found that cosmetic grade talc, without any asbestos-like fibers, caused tumors in animal subjects. Clearly with or without asbestos-like fibers, cosmetic grade talcum powder is a carcinogen.

Talc particles cause tumors in human ovaries and lungs. Numerous studies have shown a strong link between frequent use of talc in the female genital area and ovarian cancer. Talc particles are able to move through the reproductive system and become imbedded in the lining of the ovary. Researchers have found talc particles in ovarian tumors and have found that women with ovarian cancer have used talcum powder in their genital area more frequently than healthy women.

Talc poses a health risk when exposed to the lungs. Talc miners have shown higher rates of lung cancer and other respiratory illnesses from exposure to industrial grade talc, which contains dangerous silica and asbestos. The common household hazard posed by talc is inhalation of baby powder by infants. Since the early 1980s, records show that several thousand infants each year have died or become seriously ill following accidental inhalation of baby powder.

Several studies have established preliminary links between talc and pulmonary issues, lung cancer, skin cancer and ovarian cancer. This is a major concern considering talc’s widespread commercial and household use. In 1993, a US National Toxicology Program report found that cosmetic grade talc caused tumours in rats (animal testing) forced to inhale talc for 6 hours a day, five days a week over at least 113 weeks, even though it contained no asbestos-like fibres. Scientists have been aware of the toxicity of talc since the late 1960s, and in 1971 researchers found particles of talc embedded in 75% of the ovarian tumors studied.However, the U.S. Food and Drug Administration (FDA) considers non-asbestiform talc, that is, talc which does not contain potentially carcinogenic asbestiform amphibole fibers, to be generally recognized as safe (GRAS) for use in cosmetics.

ACTIONS YOU CAN TAKE:

1. Do not buy or use products containing talc. It is especially important that women not apply talc to underwear or sanitary pads.

2. Contact your pediatrician and/or local hospital and find out if they have a policy regarding talc use and infants.

3. Write to the FDA and express your concern that a proven carcinogen has remained unregulated while millions of people are unknowingly exposed.