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Where Do Generic Drugs Come From?

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Here we go again. First it was pet food from China contaminated with melamine. Then it was Chinese-made toothpaste containing diethylene glycol, an ingredient found in some antifreeze.

Another scandal erupted earlier this year when patients developed severe allergic reactions to the blood thinner heparin. More than a dozen people died. The investigation that followed found that some Chinese suppliers apparently added a cheap, dangerous compound to the raw ingredient.

Now thousands of Chinese babies are sick because melamine, the same chemical that killed cats and dogs, was added to milk to disguise dilution. Other dairy products, including yogurt and ice cream, may also have been contaminated.

All these incidents suggest that food and drug quality control is lax in China. Few Americans realize that raw ingredients for many of our medications are sourced from China.

Generic drug companies undersell brand name products in part because they buy their raw ingredients for less. How else could a discount drug chain offer a cholesterol-lowering drug like pravastatin at $10 to $12 for a three-month’s supply? The brand name Pravachol goes for over $300 for the same amount.

We do not know where discount drugstores buy their low cost medicines. One possible source is India. The FDA recently banned importation of 30 generic drugs (including pravastatin) from Ranbaxy Labs, India’s largest pharmaceutical firm. The agency cited lapses in manufacturing process and quality control. The U.S. Department of Justice is pursuing separate action alleging that Ranbaxy distributed adulterated and misbranded products.

Unfortunately it is impossible for pharmacists or patients to identify the source of their medication. For the last several years we have been hearing from readers and visitors to our Web site (www.peoplespharmacy.com) about problems with certain generic drugs. That is why we have become critical of FDA oversight.

We were recently taken to task by a Houston Chronicle reader who wrote, “The Graedons have been anti-generic drugs for years. They never miss an opportunity to denigrate generics. I wonder which companies’ stock they own.”

Just for the record, for 25 years we were strong advocates for generic drugs. Even when physicians and pharmacists questioned quality, we encouraged patients to insist on generics. We believed the FDA that generics were always identical to brand name drugs. We are no longer confident that is true for all generics. We own no stock in any pharmaceutical company, brand or generic.

We think the FDA needs to take a far more active role in monitoring foreign and domestic drug manufacturing. Currently, many companies are on the honor system: FDA checks paperwork and does little if any analysis of actual medications off pharmacy shelves to make sure they meet quality standards.

The events in China and India suggest that the honor system is no longer adequate. To keep Americans safe, our federal watchdogs need more resources and willingness to safeguard our drug supply.

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The PsychoPharmacology website (closed listserv for mental health professionals) has had MULTIPLE reports of poor response to newly out lamotrigine (generic of Lamictal, mfg by Teva.) Patients have had manic episodes and seizures. Most of the psychiatrists and psychopharmacologists are recommending sticking with the brand name Lamictal, avoiding this generic.
Many docs are filing adverse reaction reports with the FDA.

Although some of my prescription medications are generic, I feel that I have to trust the vendor (Medco) to provide drugs that are safe. However, I no longer buy OTC generic medications. I look for the "produced in (country or USA address)" and won't buy a product labeled "distributed by . . .". Sadly, in the USA it has become buyer beware because the FDA no longer is reliable. Our clothing and almost everything we buy must be labeled with country of production, but not the medications that we take to improve or to stabilize our health. What a disgrace!

I've tried three different blood pressure drugs-all with severe side effects.

The worst was the smallest dose of Lisinopril and I'm wondering if Walgreens gets generics. I'm still dealing with the weakness and pain in my legs seven months later.

Acupuncture has stopped the burning and throbbing but the weakness and a little pain remain. That was with only 21 days on the drug!

My husand takes carvedilol, which is the generic for Coreg. He takes one 6.25 mg. pill each a.m. He hasn't had any problems with it, but I wondered if there had been any reports of any difficulties with this drug. It is a beta-blocker. He also takes one 75 mg of Plavix which has no generic, and glipizide 5 mg.

I take Fosamax which has recently become available as a generic. My Dr has switched to Fosamax plus D which extends the name brand for my insurance. My concern is that a generic could be a sugar pill and with Fosamax it would be a year or more before it became apparent.

I have worked for the government and it really opened my eyes to how at risk all of us are. We all think that FDA, USDA, and such really police industries that make unsafe products but this isn't so. It is BUYER BEWARE...with anything you may purchase to use or ingest....food, containers (BPA baby bottles), medicines, so called licensed professionals, etc. It takes tragic outcomes and public outcries before anything ever changes.

Many brand name medications are made outside of North American just like generics. Also, the excipient in both cases most definitely come from overseas. Just because it is a brand name doesn't mean it is made in the US or Europe.

I recently took Amoxicillin/Clavulante 250mg/125mg (generic of Augmentin) made by Sandoz. Do you know if there have been any findings of Melamine in this drug or any other generic drugs sold in the US? I had no untoward side effects. If you do not know that, then do you know where Sandoz gets it raw ingredients for making this drug?
Thanks very much,
George

PEOPLE'S PHARMACY RESPONSE: INGREDIENT SOURCES ARE USUALLY A CLOSELY GUARDED SECRET.

my 15 year old son is presently being hospitalized for Stevens Johnson Syndrome like symptoms. The Dr's are perplexed about what triggered this illness. I'm at his bedside researching the web and have learned that drug interactions are one of the known triggers for SJS. Ibuprofin is a known culprit. I was treating him at home prior to this episode with generic ibuprofin for relief of cold symptoms. Could this be the cause? He has taken brand name ibuprofin several times before without incident. Any insight on this would be greatly appreciated.

PEOPLE'S PHARMACY RESPONSE: NSAIDS SUCH AS IBUPROFEN CAN TRIGGER THIS VERY SERIOUS SKIN REACTION. ANTICONVULSANTS ARE THE MOST COMMON CULPRIT, BUT OTHER DRUGS CAN CAUSE SJS AS WELL. AFTER HE HEALS, HE WILL LIKELY NEED TO AVOID NSAIDS IN THE FUTURE. PLEASE ASK THE DOCTORS ABOUT THIS.

I recently have been paying attention to the labels on my med bottles. Little did I know that they come from India and Israel and places I never heard of. I know the FDA is not on their toes. What can a person do about this? BW

Is amoxicillin safe if it comes from India?

I too also had a very bad reaction to a generic drug that was made in India. The only reason I know it was made in India is that after the reaction I did some investigating. I put the name of the the company "Dr Reddy's" in the search line and yes made in India. So going further, I entered each company listed on all the generic drugs my husband and I take, and guess what? All made in India.

There are many articles you can read under this topic on line. I am very angry! Why are we not made aware of this? Why do we not have the choice to buy our prescription that are made in the United States? Bottom line.... Money! Many people are getting rich at the expense of our health. We need to make every one in the United States aware of this!

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