FDA panel says risk of opioid use in kids’ cough medicines outweighs benefits
A federal advisory committee sent a strong message to the Food and Drug Administration on Monday, declaring nearly unanimously that the risks of using certain opioids in children’s cough medications outweighs the benefits.
“We have a disease with a very low risk profile, yet we’re looking at a drug that has a risk of death,” said Dr. Christy Turer, an assistant professor of pediatrics, clinical sciences, and medicine at the University of Texas Southwestern. “That, to me, seems very disproportionate.”
The recommendation by the FDA advisory committee was part of the agency’s ongoing effort to consider whether and how opiates and opioids should be used in medicine for children, an issue that has been the subject of hearings and warnings for a decade. The panel on Monday was convened to consider whether the benefits of children using cough medications containing codeine or hydrocodone outweigh the risks, focusing specifically on children in two age groups: those 6 to 12, for whom the FDA already recommends against using codeine for cough, and those 12 to 18.
Unfortunately, we were quite surprised when, on May 10, 2017 when the FDA, acting on its own, sent out a general notice stating, “As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.” (Emphasis added)
We don’t know why the FDA sent this notice out when, in fact, in November 2015 there were two epidemiological scientific studies linking the drugs with aortic aneurysms and dissection. Compare this with the notice that the FDA sent out in May 2016 when, based solely upon their analysis of their adverse database (which is appreciably weaker in evidentiary strength than peer-reviewed, published epidemiological studies) they warned of a new syndrome associated with the drugs which the FDA, itself, named, “Fluoroquinolone-associated disability syndrome”. The only explanation which appears to make sense is the change in Administration and philosophy.
Furthermore, the litigation is greatly hindered by the fact that some 98% of the fluoroquinolones sold in the U.S. are the ‘generic’ form and a recent U.S. Supreme Court decision absolved the ‘generic’ manufacturer of any liability for their drugs. Three states, California, Illinois and Vermont, currently allow suits against the ‘Brand-name’ manufacturers for injuries caused by the generic version of the drug. Nevertheless, the fact that some 98% of prescriptions are for the generic form has prevented many law firms to decidece to get involve din the .litigation and, unfortunately, ‘mass tort litigation’ against pharmaceutical manufacturers usually requires time, manpower and financial commitment from a large number of firms.
Proton Pump Inhibitors
Dr. Restaino became involved in the national proton pump inhibitor litigation in 2016, initially in regard to the PPIs and acute interstitial nephritis/kidney disease litigation. In November 2017, Dr. Restaino began putting together the PPI and gastric or esophageal cancer litigation, reviewing the initial 3 epidemiological studies published in November and December 2017 and then the March 2018 study looking at esophageal cancer. We have developed the main national experts involved in the litigation and Dr. Restaino went to Norway in February to meet with two of the major experts there, each of whom is now working with us. While Dr. Restaino did not discover the link between gastric and esophageal cancer and PPIs, he reviewed these published studies and brought them to the attention of the legal community. We continue to follow the science and epidemiology which now includes 8 epidemiological studies finding an association with gastric cancer, another 4 studies linking esophageal adenocarcinoma with the use of PPIs and, recently, 2 epidemiological studies linking PPIs with primary cancer of the liver.
We’d like to share with some good the news regarding the incretins and pancreatic cancer litigation:
While in 2016, the trial judge dismissed the entire incretins litigation based upon the legal issue of ‘preemption’ (stating that the FDA had published that there wasn’t enough science to warrant a label change at that time, therefore ‘failure to warn’ suits were barred), on December 6, 2017 the 9th District Court of Appeals disagreed with the trial judge and reinstituted the litigation.
Talcum Powder and Serous Ovarian Cancer
We are also actively involved in the national MultiDistrict Litigation (MDL) involving long-term (over 4-years) of talcum poder in the genital area and the susbsequent development of the serous form of ovarian cancer. Dr. Restaino is a member of the MDL’s Science Committee and is currently actively working with the epidemiology experts as they write their reports for the federal judge overseeing the litigation.