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Generic Drugs From India and China May Not Be Safe

Joe and Terry's Blog June 26, 2007

Generic Drugs From India and China May Not Be Safe

It’s worse than we imagined.

For the last five years or so we have been sounding an alarm about generic drugs. That’s because we’ve been hearing from readers and listeners that sometimes their generic medicine has not worked as expected. In other cases they have experienced unpleasant or even dangerous side effects.

For almost 30 years we championed generics as a wonderful way for consumers to save money. We believed that the FDA was protecting consumers from poor quality medications.

Within the last decade, however, there has been a tremendous shift in the source of medications. Both raw ingredients and finished generic drugs are increasingly coming from countries like India and China.

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

It reveals that over the last seven years FDA has made 200 inspections of plants in both countries compared to 1222 quality insurance inspections in the U.S. last year. There is no possible way for FDA to inspect all the plants in China and India that are producing pharmaceuticals that land on American drugstore shelves.

The intense competition among generic drug makers and their search for the cheapest raw materials has driven the huge increase of imports. The same motivation drove pet food manufacturers to purchase wheat gluten contaminated with melamine from China. We worry that the FDA cannot guarantee the safety of these inexpensive pharmaceutical products any more than they could protect our pets.

If you have experienced a problem with a generic drug you can add your comment on the home page of this Web site: http://www.peoplespharmacy.com/archives/generic_drug_problems/report_generic_drug_problem.asp

 

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Comments

The Ranbaxy generic for Diflucan from India did not work for me.

I think you're greatly overstating risks from generic medications from abroad, unnecessarily scaring people away from taking cheaper but equally effective generic drugs, and ironically implying that brand-name drugs are safer! Numerous US-based pharmaceutical companies get their brand-name drugs' active ingredients from other countries, so there's nothing inherently safer about brand-name drugs nor anything more dangerous about generics.

What's ironic is that as under-regulated as prescription drugs are, so-called "nutritional" and "herbal" supplements are completely unregulated - when you buy something labelled a "supplement," you have NO WAY of knowing what's in it -- whether it really has as much of the ingredients as it claims, the purity of them, whether it has, say, mercury or lead, etc etc. This is all because Big Supplements (yes, akin to Big Pharma) fought tooth and nail against FDA regulation of their products, and got Congress to grant their wishes in DSHEA.

So, yes, at the pharmacy counter, buyer beware -- but in the supplements aisle - buyer REALLY beware.

Strangley, I have gotten nose bleeds, from an 81 mg childrens' ASA, whereas,a 5 gr. Bayer, does not seem to cause that same side effect.

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Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio.

© 2007