side effects and adverse events

[Scout]

Do you know if any of the medications you are prescribed (oral and/or topical) have side effects that can affect your eyes? What about the supplements and vitamins you are taking?

This article, published in the Archives of Internal Medicine, is creating quite a buzz. Last week, most broadcast news and online news services featured this study in their health news sections. Here is a link to the abstract of the study.

http://www.ncbi.nlm.nih.gov/pubmed/21911629

Many new drugs are aggressively promoted. The public may not realize that even with US Food and Drug Administration (FDA) approval, important uncertainties about the benefits and harms of these drugs remain. We assessed the US public's understanding of the meaning of FDA drug approval and tested how brief explanations communicating drug uncertainties affect consumer choices.

snip

Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25% mistakenly believed that the FDA approves only drugs without serious side effects.

A substantial proportion of the public mistakenly believes that the FDA approves only extremely effective drugs and drugs lacking serious side effects. Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices. Nondirective explanations worked as well as directive ones.

Here is a link to one of the online articles that features this study. From WebMD: http://www.webmd.com/news/20110912/s...efits-vs-risks

The study shows that just giving people information about drug benefits and harms isn't going to solve the problem, says Michael Steinman, MD, associate professor of medicine at San Francisco VA Medical Center. He wrote a commentary to accompany the study.
People need to know what questions to ask, he says.
Suppose there is a new cholesterol-lowering drug. "There are some important questions you would want to ask," he says. Among them:
• Has the drug been shown to reduce strokes and heart attacks?
• Does it reduce them more than the other choices?
• Has the drug been around long enough that we have a good sense of its true benefits and harms?
The latest, greatest drug is not always best, he says. As an example, he and Woloshin point to Vioxx. The anti-inflammatory drug had sales of $2.4 billion before being withdrawn in 2004 due to its link with heart attacks and strokes.
Another expert, Michael Cohen, RPh, ScD, president of the Institute for Safe Medication Practices, thinks some of the study findings will be a surprise to consumers. "I would suspect that many consumers are unaware that not all adverse events can be detected during clinical trials."
When a drug is approved and becomes more widely used, new side effects can surface, he says.
Consumers can keep tabs on this information, he says. One option is by checking Medwatch, the FDA Safety Information and Adverse Event Reporting Program. The Institute for Safe Medication Practices also posts drug alerts on its consumer site, consumsermedsafety.org, Cohen says.

There are many places to go on the Internet to find out whether any medication you are taking has the potential to affect your eyes but there is so much information that it can be confusing and may or may not be from reliable sources.

However, after finding out several medications I was taking did cause side effects that affected my eyes, I started doing research and now check out all medications prescribed to me--and not just the topical ones.

Warning: Don’t immediately stop a medication without checking with your doctor. Research the possible side effects and adverse events and then take the information to your doctor to discuss your options.

Here is a list of websites that I find beneficial and reliable to check out side effects and adverse events.

Medwatch: The FDA Safety Information and Adverse Even Reporting Program
http://www.fda.gov/Safety/MedWatch/default.htm

Drugs.com drug information:
http://www.drugs.com/

DrugLib.com: drug information
http://www.druglib.com/

RxList drug information:
http://www.rxlist.com/script/main/hp.asp

Daily Med: U.S. National Library Of Medicine, Institutes of Health, Health and Human Services:
http://dailymed.nlm.nih.gov/dailymed/about.cfm

WebMD drug information:
http://www.webmd.com/drugs/index-drugs.aspx

Scout

[poppy]

Do you know if any of the medications you are prescribed (oral and/or topical) have side effects that can affect your eyes? What about the supplements and vitamins you are taking?

I think it is an issue for dry eye sufferers in that so many medications can cause/worsen dry eye, and that often there is very limited information available for us to decide whether we should take that medication or not.

Just listing "dry eye" as a side effect, isn't really enough information, especially when we already know ever other medication can cause dry eye. If medications listed percentages of people affected, with some kind of measurements (eg, an average decreased tear break up time of 5 seconds), then that would be a lot more meaningful. I also think a lot of drugs known to cause dry eye don't specifically list it. I think we know that anything with dry mouth as a side effect can also create dry eye but this isn't always specified.

The problem, I suppose, comes down to the fact that dry eye is considered an insignificant problem and therefore is never studied in any detail.