Be Safe with Rx Drugs

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Before you take ANY new drug, download the "Prescribing Information" for that drug.

The "Prescribing Information" is a legal document which must be approved by the FDA. It has to be kept up-to-date. It is the "label" you see mentioned in articles about the drug. Unfortunately, years ago the drug companies got the FDA to remove the requirement that a copy of this information be given to consumers when they purchased the drug at a pharmacy, and many people do not even know this important document exists.

The Prescribing Information will list all the known serious side effects of a drug. When the FDA issues a slap on the wrist to a company that has not disclosed a serious drug reaction or side effect, it makes the drug company mention the side effect or serious reaction in the Prescribing Information. The Avandia Prescribing information has listed heart failure as a concern for years and it later it added macular edema (swelling in the retinal area that can cause blindness.) Unfortunately, few doctors have the time to keep up with label changes, so often they are unaware of serious side effects that have been linked to heavily marketed, popular drugs.

Make sure you understand the Prescribing Information.

If your medical knowledge isn't good enough to understand the wording, do not be shy about calling up your doctor and asking him to interpret it to you. The information may be as big a surprise to your doctor as it is to you. When I have asked doctors about information in the Prescribing Information, including black box warnings, they have often not known it was there. Sadly, they have sometimes told me that the known side effect I was experiencing was nothing to worry about when, in fact, it was. I campaign to make people more aware of drug side effects because I suffered permanent harm from a known side effect of a drug that my doctor brushed off as not a concern.

If there are serious side effects, ask your doctor whether there is testing that can spot these side effects early enough to prevent permanent damage and make sure your doctor does those tests.

Even here, there is the concern that the drug company may have told your doctor that certain tests can guarantee safety when this is not true.

For example, with some drugs, including Rezulin, by the time your liver function tests came in abnormal, the damage was already done and you might not recover. With Zyprexa, by the time your blood sugar became abnormal, you could have sustained irreversible damage, too. Since we learned that the drug companies selling these dangerous drugs may offer insurance to your doctor to cover claims if you sue him after experiencing kind of permanent damage as an incentive to get him to keep prescribing a dangerous drug, as was done with both Vioxx and Zyprexa, you can't trust your doctor's assurances 100%.

Documentation of how drug companies market known dangerous drugs by offering liability insurance can be found HERE

Ask if there is an older, better understood drug or other healing strategy, like exercise and diet, that could be used instead of the newer drug.

In the case of Avandia, diet and exercise provided much better outcomes for people with diabetes and prediabetes than did the drug. The alternative drugs or strategies are usually much cheaper, too.

If a doctor makes a claim that a new drug does something really important no other drug does and that is why you should take it, investigate the data on which that claim rests.

Many people with diabetes were told that Avandia would rejuvenate their beta cells, and that was why they should take it even if they were gaining tens of pounds and swelling up like ticks. This turns out to have been a claim based on the most flimsy of evidence--much of it derived from the study of another, more dangerous drug no longer on the market--that was recently completely disproved by the DREAM study.

Vioxx was sold with the promise that it didn't cause the stomach bleeding other NSAIDS cause, which was also false. (My mom ended up in the ER thanks to stomach bleeding from Vioxx.) More recent data shows that Vioxx and related expensive, dangerous, new drugs are no more effective than Ibuprofen.

Right now, people taking incretin drugs like Byetta are being told that this drug will rejuvenate their beta cells, but the evidence for this is also weak and is derived from mouse studies. One fact everyone with diabetes must memorize is this: Rodents have very different pancreas function from humans and many drugs have effects on rodents that they do not show in humans. And later research found that though the drug was growing beta cells in these rodents, they were highly abnormal cells and some were of a type that might turn cancerous.

All this sounds like a lot of work, and it is. But since your doctor is too busy to do it, you will have to. It is YOUR body that will pay the price if you take a toxic drug.

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