Monday, May 15, 2017

Nearly a Third of Drugs Hit by Safety Issues After FDA Approval

Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32% of the drugs had safety issues after approval.

“That is very rarely a drug withdrawal, but more commonly a black-box warning or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” said study leader Dr. Joseph Ross. He is an associated professor of medicine and public health at Yale University.

Of 222 drugs approved by the agency during the study period, three were withdrawn, 61 received boxed warnings and 59 prompted safety communications, the findings showed.

Drugs most likely to have post-approval safety concerns included biologics, psychiatric drugs and medicines approved through the FDA’s accelerated approval process. The report is timely because the FDA is under pressure to accelerate drug approvals, the study authors noted.

“It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up.” Ross said in a university news release.

To assess experimental drugs for safety and effectiveness, the FDA relies on pre-market drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less. This makes it hard to detect safety issues that might surface once more patients use the drug over a longer time period, the researchers explained.

The findings were published May 9 in the Journal of the American Medical Association.

My Take:
When I review a new patient’s entrance case history the section on “current medication” is often a focus. Too often this section will list five or more medications. Often the patient provides a separate sheet of paper listing various medications. Sometimes patients leave this section blank thinking that the drugs they take are not relevant.

If I am not familiar with a drug, then I review it on If they are taking several medications then I must review the potential drug interactions. As I have mentioned in previous blogs, it is common for a drug to have serious interactions with several hundred other drugs.

However, if the drug is relatively new to the market, then I review the post-release reports. This section is where physicians reports side effects and drug interactions not listed by the drug company upon release. It is only after these reports pile up that the FDA takes a second look at the safety of a new drug.

Cipro and all the fluroquinones, broad spectrum antibiotics, are a good example. Patients suffered from tendon and ligament tears, neuropathy, and autoimmune issues for years before the FDA acted. It wasn’t until large internet support groups attracted media attention that the review process started. Today, with all the black box warnings on this group of antibiotics, there are still 31 million scripts written for Cipro every year. Most of them for UTIs (urinary tract infections) for which the use of Cipro is clearly contraindicated.

The Bottom Line:
Drugs are not safe. They all have side effects. This is what happens when you force biochemical alteration in the human body. Sometimes drugs are necessary but they should be used with caution. Please be a self-advocate – learn everything you can about any drugs you take and limit medication, even OTC medication, as much as possible.

Source: May 10, 2017 National Institutes of Health

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