A study recently revealed that certain steroids may increase the risk of heart attack when administered after surgery. The drug, Medrol (methylprednisolone), is typically prescribed to treat asthma, allergic reactions, and inflammation. Dangerous drug lawyers at Pintas & Mullins Law Firm examine the risks of taking this drug, and who may be most vulnerable.
The study was presented at an American College of Cardiology conference by researchers from Ontario, Canada. This finding is important because inflammation after cardiac surgeries such as cardiopulmonary bypasses is very common, and physicians typically prescribed a steroid like Medrol to relieve the inflammation.
Inflammation after cardiac surgery can cause a series of health complications, some more severe than others. Specifically, it can cause an abnormal or irregular heartbeat and respiratory problems, which were the primary reasons physicians prescribed steroids to these patients. Researchers noted that there needs to be more study on how to reduce the risk of irregular heartbeat in cardiac surgery patients without using steroids or other risky medication.
The study was conducted in 80 medical facilities from 18 countries, and included over 7,500 adult patients. The average patient studies was 67 years of age and about 60% were male, most of the cardiac surgeries were for valve problems and coronary artery bypass grafting (CABG).
Medrol is typically given in 500 mg doses intravenously during the operation, however, the steroids failed to improve patient outcomes after 30 days. This statement was not influenced by patient age, gender, surgery type or length, or diabetic status. In sum, the study found that prescribing Medrol did not improve patient outcome, though it did increase the risk of suffering a heart attack after surgery.
Researchers are not aware, however, why exactly the steroid was causing heart attacks in some patients. They did provide a few potential explanations: first, that Merdol was interfering with white blood cells’ ability to migrate and repair heart injury; and second, that perhaps the steroid caused resistance to insulin in the bloodstream, which would prevent glucose from helping the heart recover from surgery.
Drug Safety Trials Need Improvement
This study was unique in that it examined data from patients in so many different countries, from so many different demographics. Problems have been raised by advocacy groups in the U.S. recently over the lack of diversity in our clinical trial system.
In response, the FDA Commissioner recently stated that the agency would be launching an action plan to promote greater diversity in trial patient populations, and confirmed that there is a troubling gap in our drug and medical device safety data. She further assured public advocacy groups that the FDA will create a real solution to recruit more women, Latinos, African Americans, and other demographics.
Most clinical trials in the U.S. include a significantly higher ratio of white male patients, which then influences how pharmaceutical and medical device companies report their data on safety and efficacy. There are several reports noting that racial minorities are underrepresented in clinical trials, and many are now urging the FDA to make such diversity a requirement for all future trials.
Both gender and race play a role in how drugs are metabolized in the body, which can significantly change the frequency or severity of its side effects. A well-known example of this disparity is for the sleeping drug Ambien, which now comes with labels recommending women take significantly less than men.
Our team of dangerous drug lawyers have been advocating on behalf of those seriously injured by pharmaceuticals and medical devices for nearly three decades, and have won millions for our clients. If you or someone you love developed a serious, life-threatening side effect from a medication or device, contact our firm immediately for a free legal consultation.