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FDA Issues an Import Alert for 30 Generic Drugs from Two Plants in India

By September 17, 2008

News from the FDA
Dr. Mike brings you the latest news from the U.S. Food and Drug Administration including alerts, new drug approvals, new drug indications, and first time generic drug approvals.

The U.S. Food and Drug Administration (FDA) yesterday issued an import alert for generic drugs produced at two Ranbaxy Laboratories in India. Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States.

The FDA is concerned that these plants do not meet the FDA's safe drug manufacturing standards. However, FDA states that it has no evidence to date that Ranbaxy has shipped any defective products. Additionally, the FDA considers Ranbaxy generics already in the U.S. to be safe and the agency is not ordering any of the drugs in question to be removed from pharmacies.

The FDA “recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.”

The FDA import alert includes some commonly subscribed generic medications, such as pravastatin and simvastatin used to treat high cholesterol; metformin and glimepiride used to treat type 2 diabetes; loratadine OTC used to treat allergies; and, fosinopril used to treat high blood pressure.

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Comments
September 22, 2008 at 7:35 pm
(1) Fran says:

Dear Dr. Mike,
I’ve been taking Simvastatin for awhile now, the generic of Zocor. But I have been experiencing muscle fatigue and unexplained pains–and I noticed these long before I ever heard that a statin can cause problems for some people. Yet my doctor says that I would have known long before now if the stain was seriously affecting me. Yet I’ve been told by at least one doctor that a side-effect (or allergy) can crop up concerning something that has never caused a problem previously. But because I felt that the pains and strange muscle fatigue (especially in my upper back)were growing worse too quickly to attribute them to “aging,” I decided to check that out for myself and stopped taking the Simvastatin. And the pains have, for the most part, lessened quite a bit and aren’t nearly as pronounced. But how can I know if this is coincidental unless I stay off the statins for a month or so and then go back on them and see if the discomfort returns?

I know not to stop any other prescribed medication, but my husband’s Internist told him to stop his statins for 3 months last year so they could check something or the other (not the same statin I’m on). And I plan to talk with my cardiologist about switching me to Zocor or some other statin . . . just not a generic. And perhaps there will be a statin I can tolerate better. For instance, they tried me on Lipitore and I broke out in a rash that made my skin look as if I’d been burned. So Zocor/Simvastatin is not the first statin I’ve been on.

Recently I read in your newsletter that Simvastatin was not a safe generic, but now it has been removed from the Alert List. But I have decided to get off Simvastatin in place of some other statin, anyway. I’d rather pay the difference in price that Medicare does not pick up. How important is it to save money and chance serious harm? Is India (and other such countries) considered a safe place from which to get serious prescribed drugs? (We lost one beloved pet to the Chinese dog food!) Yet Americans are told not to get any drugs from Canada? Who’s running this curious state of affairs, anyway? Are we shopping around and giving the “order” for Simvastatin and other drugs to the cheapest bidder? I’m losing a little more “trust” and faith, day by day, in the Good Ol’FDA. It’s scary.

Thank you for the very rare and valuable service you provide.
Franlee

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