Goldsmith & Goldsmith, LLP Goldsmith & Goldsmith, LLP
New York 212-421-5500
New Jersey 201-429-7892
Main Menu

Medication Errors

In a study recently published by the Journal of the American Medical Association (http://jamanetwork.com/journals/jama/article-abstract/2625319), researchers reported that nearly a third of drugs approved for usage by the Food and Drug Administration are subsequently found to pose safety risks.

To be approved, a medication must be shown to be both safe and effective. Achieving approval status however, often means the involvement of fewer than 1,000 patients and a follow up period of less than six months. Such a small sample size of patients can mean that a true cross section of society is not achieved. Moreover, such a brief follow up period may result in absence of any data regarding harmful side effects which appeared not months but years after patients took the medication.

During the course of their study, researchers reviewed over 200 drugs which had been approved over the last 15 years and of these, the FDA took action against 32%. These actions included a demand that the drug be taken off the market, a black-box warning be issued - the agency's most serious safety alert - and the issuance of special safety communications which advise both doctors and patients about newly identified concerns.

Of course, all drugs will likely have a side effect of some kind. Furthermore, it is probable that given the realities of the issuance of a new drug, there will be instances where a side effect, even a serious one, will remain undetectable even with a thorough clinical trial. The question will always be whether the risk/benefit balance is acceptable or not and that will depend on factors like medical need, available treatment alternatives, seriousness of side effects and frequency of occurrence. That being said, it is apparent that 32% is a number that is far too high and a response time of 4.2 years by the FDA can mean that it is already too late for many. The FDA and pharmaceutical companies can and should do better.

No Comments

Leave a comment
Comment Information

Case Histories

How Our Medical Expertise Helps You

Any lawyer can win damages in egregious cases such as operating on the wrong body part. Many firms have the resources to hire experts. But few lawyers truly understand the medical science of medical malpractice litigation. As a result they may fail to recognize a viable case, unwisely pursue a weak case, or stumble in cross-examination of those medical experts.

Learn More

Email Our Experienced Attorneys

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close
Email Us