By Dan Roberts – MDSupport.org
“Tom”, a 73-year-old male, complained of severe dry eye syn- drome and loss of acuity after one injection of an anti-VEGF drug for treatment of wet macular degeneration. Tom had previously undergone four months of treatment with a similar drug, but his physician recommended changing to the newer and less expensive one.
Both drugs had been clinically-tested and FDA-approved for ophthalmic use. Dry eye syndrome was not reported in the trials as an adverse event for anti-VEGF drugs, so the physician did not suspect it to be related. Instead, he prescribed medication to treat Tom’s new symptom. Tom refused the medication, saying he felt that his condition may be an adverse event so rare that it was not reported in the trial results. He did not agree with his physician’s opinion that the benefits of the new drug outweighed the risk in this case, and he insisted that he be returned to the original treatment. After doing so, Tom’s condition improved, and his vision returned to baseline.
Agencies such as the FDA are responsible for approving drugs and for monitoring their safety after reaching the market. Timely and accurate reporting of side effects and serious adverse events (SAE’s) by pharmaceuticals and physicians is important, especially in the case of newly marketed drugs. Physicians are expected to report to the pharmaceutical companies, and the companies are expected to take appropriate action when necessary. The safety of the public depends upon compliance with reporting procedures. Unreported SAE’s, however, are still too common, and can lead to public health disasters. Physicians and pharmaceutical companies are obliged to comply with the reporting process, and patients play an important role as well. Every patient should be aware not only of the pre-market discovery of side effects and SAE’s of a particular drug, but of the potential for new and unexpected events.
Patients should be encouraged to report all physiological and psychological changes during treatment, whether or not such changes are reported in the trial results and discussed in the prescribing information. Such reports should be made to the physicians, but in the event that a report goes no further, patients need to have the opportunity to communicate directly with the drug companies and governing agencies, and to share information with one another.
An Internet site at http://www.eHealthMe.com is one solution. The site has an interactive database for use by patients to identify, track, and report their individual side effects and adverse events during drug therapy. The web-based application contains a searchable database of labeled side effects, SAE’s, and warnings for individual drugs on the market. Additionally, the application allows patients to anonymously enter information and communicate with one another about personal conditions not listed.
The newly-entered information is tabulated by drug, type and frequency, and the results are accessible to physicians, pharmaceutical companies, and governing agencies. The intention is that this complement to the reporting process might expedite discovery of new post-market side effects and SAE’s, allowing for more immediate and effective intervention when necessary. To make a report, go to http://www.eHealthMe.com