Published By: Typethink · On: 13th Dec 2012

The most frequent concern for most patients is the possibility of a serious side effect of a medication prescribed for their arthritis. For some patients this risk is almost more of an issue than the disease being treated. Since starting practice in 1991, I have definitely noticed this rising concern. I have not come across a review indicating why this is so, but I can make a good guess.

The news media often reports terrible drug side effects without giving any background on possible related causes of the side effect such as other illnesses. They almost never indicate the percentage of patients who developed the problem.  A medical expert in the associated disease is rarely interviewed or given the chance to put the adverse event in perspective. Instead there is usually a heartbreaking interview with a patient or family member. These types of stories grab headlines, but they should not be the basis of an individual treatment decision.

The way that adverse events are reported in patient brochures fail to quantify the risk of the event or even define what an adverse event is. In my opinion a side effect is a common but usually mild effect of a medicine. Examples include sedation with allergy medicines, nausea with certain antibiotics, or dizziness with pain medicines. These side effects can be avoided by taking medicines at certain times of the day or with food. Most mild side effects go away with routine usage of the medicine.

In recent years pharmacy handouts and web pages give a long list of “adverse events,“ not side effects. It is very important to understand the difference. An adverse event is any complaint or medical problem reported by those using the drugs during the clinical trials of the drug or post marketing reports. Because patients are required to report all problems, complaints, or medical issues, the adverse event list can be very long, including hundreds of problems. Most of these problems are not related to the drug. The  FDA requires that these lists be published in all ads or websites from the company making the drug. The drug companies and most pharmacies must comply or risk very large penalties or lawsuits.  The downside of this is that the patient and doctor must both try to make sense of this list of sometimes serious problems such as cancer, heart attacks, suicide, liver failure, or death. My job is to make sense of all this by reading original articles related to the drug or reading reviews by experts in the field related to the drug.

Adverse events are analyzed statistically by comparing their incidence to either a placebo group or a population that best represents the patients being treated. I spend a great deal of time reading the safety section of drug studies, so that I can give my patients a practical assessment of the risks of a drug. Drug safety is also monitored by the pharmaceutical companies, the FDA, and committees in other countries. The results of these studies are published. An example is “DANBIO,” the Danish registry for biologic therapy. They track incidence of cancer, infection, and rare diseases in arthritis patients on the newer biologic type drugs such as Enbrel or Remicade.

Here is the good news. Most adverse events are mild and occur at a rate similar to control subjects, who are not on the medication. Serious adverse events are very rare. Even if there is a higher risk of the adverse event in those on the drug, the percentage of patients actually having the serious adverse even is typically very small. Frequently thousands of patients must be treated in order to discover these small increases in risk.

Please remember to not worry excessively about the list of side effects or adverse events. Please go over common issues that may occur with the drug. Before taking a drug, review serious problems that appear to be directly related to drug usage. Drug safety monitoring is very important to all rheumatologists, the drug companies, and the international medical community.

I graduated medical school in 1985. I can assure you that most drug treatments of rheumatoid arthritis and similar conditions are much more effective and safer than 27 years ago. New tests and computer data base analysis give unprecedented access to accurate information regarding drug effectiveness and safety. Most recent drugs are custom designed to repair a specific dysfunction of the immune system, leaving the good parts intact and having a minimal or rare impact on other parts of the body.

Please keep in mind that the basis of all modern medicine is weighing the benefits of the drug or surgery versus the risks of the illness. This is known as “evidence based medicine.” This evidence must be validated or proven by a review of experts that typically goes on for several years. The evidence must be free of tampering or what is known as “industry bias,” such as a review by an expert receiving money or gifts from the company making the product.  Members of the American College of Rheumatology take drug reviews  very seriously. We frequently present studies from European countries, which presumably are unbiased, since they are seeking cost effective and safe treatments to be used for their own national health care systems. Medical experts are required to disclose any financial compensation from any drug company or corporation.  I am very proud to be part of this society, and I do my best to treat my patients with the most effective and safest medicines and to make these decisions based on the facts.

For additional information, Google: “ DANBIO Denmark registry,” and “ British Society Rheumatology biologics register.” For women’s health issues, Google: “OTIS teratology.” This non-profit organization monitors the effects of diseases and drugs on pregnant and breast feeding women and their children. Although these are specific organizations for specific types of patients and drugs, they are good examples of unbiased opinions regarding efficacy and safety data.

NW Rheumatology subscribes to UptoDate,Inc.  As the names states this site is very up to date. It is an online information source that is paid for by doctors or medical institutions. There are no ads. The editors are all experts in their assigned topics. We also use “The Medical Letter.” This is a well respected source of unbiased drug reviews. Other sources used by us include abstracts and guidelines from the American College of Rheumatology. I also review articles in “The New England Journal of Medicine,” and “Arthritis & Rheumatism.”

Do not fall for the simplistic hype that “medicines are bad,” and that there are natural cures with “no side effects.” If it sounds too good to be true, then it is most likely false.

Safety:

  • Please make sure that you read all print and web site information about your illness and its treatment.
  • Know the consequences of not treating a serious condition. Many diseases cause serious hidden damage. The patient will be feeling reasonably well until it is too late.
  • Review all new medicines with your pharmacist. If there are any concerns, please contact your doctor.
  • Please keep all routine appointments for lab tests and physician visits. This is very important to monitor for treatment response and side effects.
  • Please call if you have any concerns about lack of benefit or side effects from a new or current medicine.
  • For drugs that increase risk infection, please make sure that you wash your hands frequently and get an annual flu vaccine. Report any signs of infection to our office.