Drug Makers Often Fail To Tell FDA, Research Subjects, About Adverse Events in Timely Manner: Studies

Two new studies highlight how drug manufacturers often fail to tell federal regulators about serious risks potentially associated with their medications, and most researchers are fail to inform test subjects about the most serious side effects that may be linked to drugs tested on them. 

In one study, conducted by researchers from the University of Minnesota, the findings indicate that manufacturers failed to report one out of every 10 serious adverse events linked to their drugs to the FDA. The other study, conducted by researchers from Northwestern University, found that nearly two-thirds of consent forms given to drug trial test subjects do not include information about important boxed label warnings; the strongest label warning the FDA can require.

The studies were published on July 27, as research letters in the medical journal JAMA Internal Medicine.

Adverse Events Not Properly Reported

The University of Minnesota study looked at how frequently drug manufacturers met federal requirements to report when their drugs were associated with serious harm to patients. By law, the pharmaceutical companies are required to report such incidents within 15 days after becoming aware of them.

The study looked at 1.6 million adverse drug events sent to the FDA between 2004 and 2014. They found that 160,383 reports of problems, or about 10%, were disclosed to the FDA by manufacturers outside of the 15-day requirement. About a quarter of those involved a patient’s death.

Researchers found that three percent of those cases took three to six months for companies to report, and another three percent took six months or longer.

The findings raise concerns because in many cases, the FDA relies on post-market surveillance once a drug is on sale to the public before being able to determine the true scope of potential side effects.

Test Subjects Not Being Warned Of Serious Drug Risks

The Northwestern University study looked at 4,780 human biomedical research protocols between January 1, 2010, and December 31, 2012., examining consent forms given to human research subjects who were given drugs. Researchers found 44 boxed warnings, which indicate a risk of severe adverse events related to a particular drug, that were applicable to 57 of those protocols, 75% of which involved test subjects with potentially life-threatening disease.

The research found that out of the 57 consent forms that should have had boxed warning information, 36, or 63%, did not contain that information. The highest rate of failure was among non-sponsored research studies, which failed to include boxed warning information 81% of the time. Industry-sponsored research failed to disclose boxed warnings on the consent forms 56% of the time, while government-sponsored research only included the boxed warnings half the time.

For example, researchers found that three out of four studies involving the painkiller hydromorphone failed to warn subjects of the risk of abuse potential and fatal respiratory depression. Both studies involving the antibiotic Cipro failed to warn test subjects that it could cause tendon ruptures or increase weakness in patients with myasthenia gravis; and all three studies involving methadone failed to warn research subjects that it could cause respiratory depression and cardiac arrhythmia.

Many health experts say that human research subjects cannot truly give consent to participate in clinical trials and research studies if they are not fully informed of a drug’s potential side effects.