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Post-Market Safety Events

Older women with medicine into hand.Drug defects are often discovered after approval and sale

Every medication comes with various lists of warnings and side effects, some of which can be deadly. Informed patient consent means that we have the freedom to speak to the pharmacist about any prescription, and to be properly informed about them by our providers. We also should have the right to know that the drugs we are being given have been through a thorough approval process. Yes commercials frequently air on television for drug recalls and drug defects, and one has to wonder exactly why.

In order for FDA approval to be given to a drug, the manufacturer must demonstrate its safety. However, many safety issues and devastating side effects have cropped up after that approval process and raised concern. A study from the Journal of the American Medical Association has suggested that nearly one third of approved drugs from the FDA have posed safety risks only identified some time post-approval. Over the course of an examined decade, 82.4% of these drugs were pharmaceuticals and 17.6% were biologics such as blood components.

Accelerated approval process puts patients in danger

Medications and drugs should not be put through any sort of accelerated approval process. This means that their approval process is simply sped up in order to hit the shelves, with recalls and adverse events as side effects being noted at later dates. For the safety of the general public, drugs should be put through extensive testing in order to show that they treat the ailments they are prescribed for, not make them worse. Currently, the FDA is under pressure to speed up the process drugs go through for approval. According to data, 19 drugs have received approval so far in 2017, which is close to the number of total approvals for the year of 2016.

Post-market safety issues occur more often with drugs that have been through the accelerated approval process. This makes it incredibly easy for a defective drug to have adverse effects on the patients it is prescribed to, especially when the median time for a drug (or specific dosage) to be formally taken off the shelves is several years after the drug has already been approved for use. Given that almost a third of medications approved have safety issues discovered after the fact, there’s no telling how many people will continue to be affected by defective drugs.

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The effects that a drug can have on a patient can be extremely helpful in treating diseases and illnesses, but they can also have the opposite effect. Doctors and healthcare providers should always be vigilant and aware of the side effects, as well as recall status of prescribed medications and drugs. Patients are entitled to informed consent as well, and consequences can be grave if it is not given. If you or anyone you know has been injured or suffered an adverse event as the result of a defective drug, contact us today for a free case evaluation with one of our skilled attorneys. Don’t delay, tell them you mean business.

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