Stay Safe with Prescription Drugs

 

Known Drug Side Effects Can Really Harm You

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

 

The "Prescribing Information" for a drug is a legal document which must be approved by the FDA. It also 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 that this important document exists.

 

The Prescribing Information will list all the known serious side effects of a drug. While the FDA merely issues a slap on the wrist to a company that has not disclosed a serious drug reaction or side effect, it does make the drug company mention the side effect or serious reaction in the Prescribing Information.

For example, the Avandia (rosiglitazone) Prescribing information listed heart failure as a concern for years and it later it added macular edema (swelling in the retinal area that can cause blindness,) though the public only became aware of these serious concerns years after they appeared on the label. 

As of 2018,  Invokana has a serious "Black Box" warning telling patients that the drug raises the risk of lower limb amputations. Victoza has a black box warning saying it may cause thyroid cancers. 

​

Less life-threatening side effects are buried deep in the prescribing information, but some can be life changing. Januvia, for example, can cause severe joint pain that doesn't go away when people stop the drug as well as severe rashes. These occur because of the way it affects the immune system. 

ACE inhbitor blood pressure medicines like lisinopril can cause painful joints and a perpetual cough. 

 

Unfortunately, the drug companies present these side effects in a way that doesn't discriminate between those that are serious and in some cases irreversible, and those that are trivial and may not even be caused by the drug. 
 

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 and left me with permanent symptoms, including a drug-induced ringing in my ears that I have lived with for 21 years. 

​

If a drug can cause 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 that harm the kidney or liver, by the time your kidney or liver function tests come back abnormal, the damage has already been done and you might not recover.

For example, Zyprexa was an antipsychotic that was prescribed off label to people with far milder problems than the schizophrenia it was approved for. It caused permanent diabetes, but by the time a person taking it had their blood sugar became abnormal, they had sustained irreversible damage.

As a result of law suits about dangerous drugs, we have learned that the drug companies selling these dangerous drugs went so far as to 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,  so you can't trust your doctor's assurances 100% that a drug is safe. Device companies selling dangerous spinal implants have done the same thing. 

​

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

 

Is There an Older, Better Understood Safer Drug Available? 

Before you take a very expensive newer drug that is earning its maker billions, 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. Cutting carbs will give you much better blood sugars and improve your risk for complications far better than does Jardiance or Invokana. 

​

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 completely disproved by a larger, study, 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.) Eventually the data showed that Vioxx and related expensive, dangerous, new drugs are no more effective than Ibuprofen.

 

Much of the evidence for drugs' beneficial effects comes from rodent research, so 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.
 

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.