powered by centersite dot net
Medications
Resources
Basic InformationLatest News
New Cholesterol Drugs Vastly Overpriced, Study ContendsFDA May Limit 'Risk Info' in Direct-to-Consumer TV Drug AdsHealth Tip: Throwing Out Leftover MedicineFDA Announces Recall of Some Liquid Pharmaceutical ProductsIs FDA Taking Close Enough Look at Fast-Tracked Drugs?U.S. Antidepressant Use Jumps 65 Percent in 15 YearsThe Fine Print on Medication Expiration DatesAmericans Taking More Prescription Drugs Than Ever: SurveyInappropriate Med Use High in Cognitively Impaired SeniorsA Reminder That Meds and Grapefruit Don't Always MixAspirin Responsiveness Can Change After Bariatric SurgerySome Medicines Boost Sensitivity to SunPainkiller Prescriptions More Prone to Errors If HandwrittenMedication Mistakes Have Doubled in U.S. Since 2000: StudyMarket Competition Linked to Change in Generic Drug PricesIs Your Child's 'Penicillin Allergy' Real?FDA Seeks to Increase Number of Generic Drugs on MarketWhen Is an Opioid Safe to Take?Lifesaving Drugs From Pfizer in Short Supply: FDALeading U.S. Doctors' Group Takes Aim at Rising Drug PricesU.S. Hospitals Still Prescribe Too Many Antibiotics: StudyBirth Control Pills Recalled Due to Danger of Unintended PregnancyNew Drugs Show Promise as First to Prevent MigraineMedication Adherence Up With Refill Synchronization ModelModified Vancomycin May Help Fight Bacterial ResistanceScientists Tweak Antibiotic to Boost Power Against 'Superbugs'New Cholesterol Fighting Meds Target Key GeneResearchers Say PDE5 Inhibitors Don't Cause MelanomaNearly a Third of Drugs Hit by Safety Issues After FDA ApprovalU.S. Moves to Avert Shortage of Yellow Fever VaccineOpioid Use by Iraq, Afghanistan War Vets Mirrors Rest of U.S.: StudyApril 29 Is National Prescription Drug Take Back DayERs Administering More Medications IntranasallyFDA Warns Against Children Taking Codeine, TramadolPhysicians Finding Ways to Work Around Cost of Rx MedicationsRuling Out Penicillin Allergy by Testing Inpatients Saves MoneyEpiPen Out-of-Pocket Costs More Than Doubled Over DecadeAACR: Regular Aspirin Use Linked to Lower Cancer MortalityFDA Approves Noctiva Nasal Spray for Nocturnal PolyuriaFDA Approves Odactra for House Dust Mite AllergiesHow Much Melatonin Is Really in That Supplement?Antidepressant Efficacy Varies for Depressive Symptom ClustersDo You Need an Antibiotic?'Off-Label' Antidepressants Common, But Where's the Evidence?Docs More Likely to Prescribe Antibiotics If Patients Expect ThemSimilar Adverse Event Risk for Typical, Atypical AntipsychoticsRx Adherence Reminders No More Effective at 'Fresh Start' DatesThink You're Allergic to Penicillin? Check AgainExcessive FDA Regulation Driving High Drug PricesOutcomes-Based Pricing Suggested for New, Costly Drugs
Questions and AnswersVideosLinksBook Reviews
Related Topics

Anxiety Disorders
Depression: Depression & Related Conditions
Mental Disorders
Mental Health Professions

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

HealthDay News
by -- Robert Preidt
Updated: May 10th 2017

new article illustration

WEDNESDAY, May 10, 2017 (HealthDay News) -- Safety problems emerge with nearly one in three prescription drugs after they've been approved by the U.S. Food and Drug Administration, a new study reveals.

Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32 percent 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 associate 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.

At the very least, the study should inform the ongoing debate about pre-market drug evaluation, the researchers suggested.

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.

According to study author Dr. Nicholas Downing, from the department of medicine at Brigham and Women's Hospital, in Boston, "The fact that so many new safety risks are being identified after FDA approval indicates that the FDA is taking its responsibility of ensuring the safety of new drugs throughout their lifetime seriously."

However, "these safety risks emerge, on average, four years after approval. This means that many patients are exposed to these medications before the risks become clear," Downing added in a hospital news release.

Some of those risks included serious skin reactions, liver damage, cancer and even death, the Associated Press reported.

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

More information

There's more about adverse drug reactions from the American Academy of Family Physicians.