Arimidex
Comments
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otter wrote: anastrozole being marketed by Breckenridge (at least here in the U.S.) is actually being manufactured by Natco Pharma Ltd., a company located in India.
OMG !!!! Great catch Otter ! I would never knowingly buy a drug made in India. And it's only on the label that the pharmacists see ?!? Whoa. It's the natural assumption that drugs sold here are manufactured in the US. That's downright scary ! I'm going to check out the link you've provided as soon as I send this off !
As for ways to keep track of my daily Arimidex, instead of a daily organizer, I use an antique enamel pill box (prettier and more portable for when I travel) and put in 7 pills every Saturday. So that if I forget whether or not I've taken my pill, I simply do a quick count. If I am traveling, instead of lugging around my supplement bottles, I make up little packets using saran wrap and then put the packets in a ziploc bag and take one packet out each morning.
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Okay, this is too scary. Now that I know where to look, I checked the NIH site that I use and Cadila Healthcare Limited and Zydus Pharmaceuticals (USA ) which manufacture Anastozole together, manufacture it in - you guessed it - INDIA, Check it out: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19338. I'm gonna see which other of our "Approved" manufacturers are making the drugs in India0
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Medco mailorder is telling me they are using Breckenridge also. I am not sure what to do. How much of the USA generic market is actually manufactured in India. How do we find out if these are safe?
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Good Grief! I'm glad I have about 60 days of the old stuff left! Can a person ask for a certain company or is that totally the choice of the pharmacy? And if so, would the pharmacy people be the ones to talk to?
As far as traveling and pills, remember if you travel outside of the U.S. (like if you were lucky enough to be going to Jamaica, for instance), then you need to leave your pills in their prescription bottles. This is new since all the terrorist stuff, and I didn't know about it until a friend mentioned it to me (unfortunately I do NOT have any trips to Jamaica in sight. SIGH!).
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My oncologist has no problem at all with some of the generics being made in India. Their labs are put through the same tests (by the FDA) as the labs in the USA. I think if you were to look closer, there are a LOT of meds that we assume are made here, that are actually made in another country.
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lisa34lisa - Like so many things related to BC, whether or not to buy drugs manufactured in India is a matter of personal choice. However, it should be an informed choice not one made thru deception. We've heard again and again about women who are dissuaded from buying their meds from Canada because "drugs manufactured outside the US" may not have the same controls.
Personally, I am fine buying meds manufactured in Canada or western Europe. I am not fine with buying meds manufactured in India
So, for those of you who are curious, here's the list:
The following generic Anastrozoles are made in INDIA (almost all of them)
1. Accord Healthcare Inc. imprint AHI
2. APP Pharmaceuticals, LLCDB02
3. Ascend Laboratories, Llc AN;1
4. Breckenridge Pharmaceutical, Inc. AN;1 - Made in India
5. Cadila Healthcare Limited - A7
6. Zydus Pharmaceuticals (USA) Inc. - A7
7. Dr. Reddy's Laboratories Limited RDY;1
8. Karalex Pharma, LLC 3RP;1
9. Pack Pharmaceuticals, LLCAN;1
10. Three Rivers Pharmaceuticals, LLC 3RP;1
The following do not state where they are manufactured, so I'm gonna assume...
Cypress Pharmaceutical, Inc. 0376
Mylan Pharmaceuticals Inc. M;34
Roxane Laboratories, Inc. 54;077
Sandoz Inc SZ;171 -
There are only 2 generics that are clearly NOT made in India:
Kremers Urban, LLC 71;KU -made in Ireland
TEVA Pharmaceuticals USA Inc TEVA;A10 - made in Isreal.
My personal choice will be to go with Teva (which has a great track record) or Kremers. FYI, I got the information from the NIH webbsite,http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=Anastrozole&x=16&y=7 I just had to read the labels pretty closely. Thanks again, Otter. I'll start a thread which has photos of the labels so everyone can see for themselves
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I get the feeling reading this that is possible that India has a large part of the whole generic market. I am beginning to think that many of us or our family members have taken generics manufactured in India in the past. My husband takes quite a few generics. I am going to try and investigate how many of his are manufactured in India. Maybe they are quite safe.
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Where is Armidex manufactured? Is it made in the US? The Armidex I am taking is packaged in Canada (in Ontario) but as far as I know the pills are not made here.
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I was just going to ask where Arimidex was manufactured. AstroZeneca is a huge international company. It wouldn't surprise me at all if they had facilities in India or even China for manufacturing the drugs they sell.
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According to photo on the NIH site, http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=15670, Arimidex is "Made in USA".
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After reading the article on the other post about this issue, I now wonder where the active ingredient is manufactured! It could come from another country...and as long as it is mixed with inactive ingredients while here in the USA, they can claim "made in the USA"
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Lisa - You're correct, we dont know the country origin of any ingredients - active or inactive - of a drug that is "made in the USA". However, my point is that those drugs that are "made in the USA" - even if ALL ingredients come from another country - are subject to closer and more frequent testing and oversight than those manufactured elsewhere. I believe, but have not yet looked for cites, that drugs from Canada and Western Europe are also subject to careful scrutiny by their own goverments. (When I do get a chance to look, I'll post sourcesand if I find none, I'll post that as well.)
Unfortunately, drugs out of India and China have been singled out as being a bit more suspect. For those of you that haven't seen the other thread, There is an article in the Washington Post (June 17, 2007) by Marc Kaufman titled "FDA Scrutiny Scant in India, China as Drugs Pour into the U.S." http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html
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Here's one source, that gives an Overview of Pharmaceutical Regulation: By Country and talks about drugs from Western Europe and Canda being more closely regulated than India.
http://www.pharmacychecker.com/aboutop.asp
Here are the excerpts re: the countries producing Anastrozole
INDIA:
The Central Drugs Standards Control Organization (CDSCO), a division of the Indian Ministry of Health and Family Welfare, is responsible for drug approval and regulation, as well as for the licensure of pharmacies in India. CDSCO is responsible for approving new drugs for the Indian market, post-market surveillance, and enforcement actions to protect the Indian drug supply.
Under the CDSCO, the Drugs Control Administration is responsible for regulating pharmacies. They do so through the State Drug Control Offices, also called Food and Drug Administration offices, which inspect and license pharmacies, and enforce the Pharmacy Act of 1940, which require pharmacies to meet rigorous safety standards.
Pharmacies in India must comply with similar regulations as those in the U.S., such as having a licensed pharmacist on the premises during hours of operation, safe storage of drugs, particularly those with special requirements (such as insulin), and safeguarding of controlled substances. However, India's enforcement standards are generally lower than they are in the United States. Indian pharmacy members are inspected by PharmacyChecker.com to verify that they are meeting good standards of mail-order pharmacy practice.
While in many respects economically disadvantaged compared to the U.S. and countries of the European Union, India has a very large and highly sophisticated pharmaceutical industry. In fact, a sizable portion of the world's pharmaceutical active ingredients are manufactured in India. These ingredients are then exported to other countries such as the U.S. and the EU for the manufacture of final drug products.
Many drugs in India are manufactured in FDA-approved or inspected facilities. In fact, the U.S. Food and Drug Administration inspects more drug manufacturing plants in India than any other country outside the U.S. However, the drug supply in India is not as strongly regulated as it is in the U.S. and some other economically developed countries, such as Canada and the United Kingdom. Consequently, it has a higher rate of counterfeit medication. (emphasis added)
Useful Links- Central Drugs Standards Control Organization: http://cdsco.nic.in/
- Pharmacy Council of India: http://pci.nic.in/
ISRAEL:The Pharmaceutical Division of the Israeli Ministry of Health regulates that country's drug supply, pharmacists and pharmacies. Israel's system for pharmaceutical regulation is strongly based on both U.S. and EU pharmaceutical regulations.
Israeli regulations require that drugs approved for sale in that country must be manufactured using U.S. or EU standards for Good Manufacturing Practices (GMP) and USFDA or equivalent European Standards. Additionally, drugs approved for use in Israel are generally approved for use in the U.S. or EU. Israeli pharmaceutical companies are major suppliers of generic drug products to the United States.
Pharmacies are licensed by the Israeli Ministry of Health. Under Israeli law, drug labels must be in Hebrew and English.
Useful Links
- Pharmaceutical Administration, Israeli Ministry of Health: http://www.health.gov.il/english/Pages_E/default.asp?maincat=10
UNITED KINGDOM:Drug products sold in the UK are regulated by the Medical and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Evaluation Agency (EMEA). The MHRA is the United Kingdom's counterpart to the U.S. Food and Drug Administration and decides which drugs are safe and effective for citizens of the UK. The EMEA is in an agency of the European Union charged with evaluating the safety of new products for members of the EU. Drugs that are approved by the EMEA can be sold throughout the EU.
On a national level, pharmacists and pharmacies are registered with and regulated by the Royal Pharmaceutical Society of Great Britain (RPSGB). Pharmacies must be operated by a licensed pharmacist, maintain safe storage conditions and a sanitary dispensing area.
pharmacist, maintain safe storage conditions and a sanitary dispensing area.
Useful Links- Medical and Healthcare Products Regulatory Agency (MHRA): http://www.mca.gov.uk/
- The European Medicines Agency: http://www.emea.eu.int/
- Royal Pharmaceutical Society of Great Britain: http://www.rpsgb.org.uk/
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Before we scare anyone.... this manufacturer sounds open and honest.
Quoted from the original article mentioned above:
Because of U.S. drugmakers' concerns over quality control, U.S. Pharmacopoeia -- a nonprofit organization that works with drugmakers and regulators to set drug-quality standards -- opened an office in Hyderabad, a center of the Indian drug industry. Executive Director Roger Williams said Dr. Reddy's Laboratories recently became the first Indian firm to agree to pay USP to check the quality of its products.
And, Dr Reddy's is one of the least expensive generics out there. 0 -
I have very mixed feelings on this topic. On one hand, I know other countries don't necessarily regulate their drug manufacturing as well in every case -- on the other hand, I've been taking generics of various drugs off and on for years and have never worried about this. For example, most recently, I'm taking generic meds for my heart and they have worked well and I've had no trouble with them.
Most of the companies listed in various posts have good reputations. I tend to be more trusting of pharmaceuticals than OTC drugs because prescription drugs (including each company's generic) need FDA approval before they can be distributed in the US. On the other hand, I know FDA approval isn't always a guarantee that the approval process/inspection was/is very thorough. I also have a healthy dose of skepticism when it comes to journalism and many internet sites. And, there is very little that isn't global any more and very little that is uniquely made in the US.
I live less than a mile from Purdue University, which has a strong pharmacy school. I'm going to find out what it takes to get into their library (probably just walking in the door) to do some research and maybe even talk to some of the professionals there. I want to know more about the FDA approval process and various companies before I come to any conclusions.
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Thanks Jo! If the range is between 30 - 100 why does your onc want you to be at 50? I guess I am at the lower range and maybe should be taking something. What is the recommended dosage?
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People you need to get real. My guess is better than 90% of all the drugs we use, Brand and generic are made outside the USA. Simple cost analyst will tell you that. Most plants regardles of where are FDA inspected. Ask your pharmisist [sp]. he-she will tell you where the drug is actually made.
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I think things have gotten really confused. There's nothing wrong with drugs, foods or anything else , made in other counrtries. Most countries have oversight re: quality control as good, if not better than the US. If you're intereted, the pharmacy checker link that I posted gives capsule summaries of each country. However, India and China have in the past had issues with QC due in large part to the fact that their pharmaceutical industries have grown so fast. As Lisa34Lisa and the Washington Post article linked above, Dr. Reddy's has taken steps to ensure quality control.
I feel like I've unintentionally kidnapped this thread. So unless I'm expressly asked for input( or if ,I truly, truly can't resist -LOL) I'm going to confine my comments to the thread I started just for this: http://community.breastcancer.org/forum/78/topic/755313?page=1#idx_9
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MTG, I think the conversation has been interesting and good. Quality control is an important issue on many levels. I think it's important to be aware of what we put into our mouths and on our bodies and the many ramifications. Trusting our government to be the overseer of all is fine but they have limits as to what they can accomplish. The FDA itself acknowledges that it has limited people to send to other countries. Overall, I think most drugs are safe, but I also think caveat emptor is still a good warning.
I think this topic has also pointed out that the issues are complex and can be overwhelming for those who don't have the background or time or whatever to research it thoroughly.
On vit.
I take D3, 1000 IU, and will discuss testing with my dr. the next time I see him. I have no idea what my levels are but I do know about a week after I started taking it, my joint and bone pains decreased significantly. If I miss a few days, they come back. To my knowledge this isn't something my dr. tests for so I'm going in armed with information about why I think it's important. Of course, the more prepared I am, the more likely he is to have the same knowledge already 
It's just never come up so I want to make sure I have backing and can say something more intelligent than "I read it on the internet" 0 -
MTG, it is amazing the research you are able to do. I live in Canada and would love to know the "low down" on every drug I take.
The ability to be well-informed and being able to make a decision based on ALL the information is important to me. Such knowledge may or may not change a decision, but I still prefer to have the information.
Something I have never heard of before, is the amount of control US people have with their pharmacies. Prior to this, I did not even know the pharmasist could be asked all these questions or to order a specific generic. Now I am going to ask them a lot more questions.
One thing I have wondered about, why are some of those generics almost as expensive as the original manufacturer's product. I would have thought they would be half the price. Otherwise, what is the incentive to buy generic?
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NatureGrrl and Molly - Thanks for your kind words. Naturgrrl, Im going to PM you several links about Vitamin D for you to look over and arm yourself with for your next doctor's visit.
Back to Shape Ups - I just received and email from DSW that there's a 20% off sale on shape ups both in store and on line.
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Molly...
this is MY opinion only. I have nothing to back it up. With that said, at CVS the name brand was costing me $507.00. A month. No RX insurance. When I heard about the generic, I was so excited! Called CVS. $370! HU??? What??? For a generic? With that, I started calling locally owned pharmacies. Not chains. $17. $19.
Here is why *I* think there is such a difference in price. The chain stores are ripping off the insurance companies! People with good RX coverage pay $ ____ for name brand, and $ ______ for generic. Most of the time, no one has any idea how much the meds actually cost. Nor do they know that it can be bought for MUCH less money somewhere else. Often less than their co-pays.
Again, I have no proof. This is just a reason I made up. There could be much better reasons that I just am not aware of.
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Ok so I ordered them on line and then found myself passing the store and so bought them as well and have cancelled the online ones. Lots of colors. $80. For me, I found they run true to size. Is it wierd to be so excited about excerise shoes ?
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No it's not wierd, it's GOOD!
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And just to add salt to the wound, my oncologist told me yesterday that a new study has come out saying that AI's are not as effective in overweight women. He says I must lose weight. We are talking about at least 30 pounds. Since Arimidex I feel like I am swimming upstream against a strong current when it comes to losing weight. What I thought was tough before is now almost impossible.
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Sunflowers......on weight gain
I am talking from experience as this happened to me twice in my life, but fortunately was on to this prior to BC treatment.
Weight is sneaky, and my take is that the majority of BC patients lose muscle tone from inactivity and THEN gain weightt. That was one reason I did weekday weights/crunches (plus walking at least one mile) during chemo and also cycled on weekends. Not just the mental part. I knew what would happen if I didn't.
My abs tried to lie and pretend they were too weak/sick to be crunched, but I whipped those puppies into submission. I have to watch them, though, because they are sneaky.
I am continuing to slowly lose weight now that I have regained my energy post radiation. I gained a bit of weight at the end when my energy went down and I was feuling with tea and a "little something". Now, I am back to running around and I am noticing things on the scale.
So it can be done, but takes both cardio and strength training. I am hoping that doing the Seattle-to-Portland Bicycle Classic this weekend takes a couple more pounds off. If so, I will be down to the last 5 pounds which I can take off with vigorous cycling.
As for the weights/crunches, I have to do those puppies for the rest of my life. No excuses unless physically unable to. The great news is that enough exercise makes you feel wonderful and also your clothes look fab on you.
And you don't have to give up eating!!!! - Claire
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Claire - I've always been so impressed by (and secretly envious of) the shape you must be in to do your cycling. It's good to be reminded that you too have to work at it. And the, "No excuses unless physically unable to." is a great mantra esp necessary since I got up this morning, put on work out clothes, went next door to my neighbor's apt and when she cancelled on me, came back home, took off the work out clothes and went back to bed !
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Over on the "motivation" thread we have a 10 minute rule. At least 10 minutes of exercise a day. Then increase it if you can each day.By moving the joint pain seems to to be less than before.
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FYI, The new study, " Effect of Body Mass Index on Recurrences in Tamoxifen and Anastrozole Treated Women: An Exploratory Analysis From the ATAC Trial" http://jco.ascopubs.org/cgi/content/abstract/JCO.2009.27.2021v1
An article summarizing it: http://www.curetoday.com/index.cfm/fuseaction/news.showNewsArticle/id/5/news_id/2837
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Thanks MTG for the articles
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