A Food & Drug Administration advisory panel recommended that the watchdog agency tighten restrictions on drugs used during MRI scans for patients with severe kidney disease, because the contrast agents have been linked to a rare but often crippling or deadly disease called nephrogenic systemic fibrosis, according to news reports.
And the agency demonstrated its willingness to crack down on companies outside the U.S., sending a warning letter to Italian manufacturer Sorin Biomedica after complaints surfaced in Europe about its defibrillation leads.
MRI drug recommendation
A majority of members on the FDA panel recommended that the agency put tight controls on the use of GE‘s Omniscan and Covidien‘s Mallinckrodt Optimark contrast agents, which contain gadolinium. The drugs are used to provide better contrast during magnetic resonance imaging scans. The FDA began regulating the drugs three years ago, after they were linked to cases of NSF in patients with severe kidney disease. Some members of the panel pushed to ban use of the drugs altogether in at-risk patients, according to the Pro Publica website. The watchdog agency generally accedes to the recommendations of its independent panels, but is not bound to do so.
Covidien’s Mallinckrodt subsidiary opted to label Optimark as “contraindicated” for patients with severe kidney disease, leaving GE’s Omniscan to bear the brunt of any changes the FDA decides to make.
Foreign foray at the FDA
The agency’s Oct. 29 letter to Sorin Biomedica underscored a new level of vigilance promised by its new regime under commissioner Margaret Hamburg. Citing complaints in Belgium, France, Britain, Japan, Germany and Greece — one of which, in Belgium, “may have caused or contributed to a death or serious injury” — the FDA warned the company that it must report any adverse events concerning its devices that occur outside the U.S. if it wants its products on the market here.
“Events that occur in other countries that involve a device that is also marketed in the US could have a significant bearing on our ability to recognize and act upon an impending public health issue in this country,” wrote Timothy Ulatowski, director of the Center for Devices and Radiological Health’s compliance office. “For example, complaint No. 08/068 ELA was received by your firm on June 11, 2008, from Belgium. The complaint, for the Isoline 2CR6 Lead … alleges that the patient had chest pain, perforation, and states that the patient was hospitalized due to receiving repetitive shocks, i.e., “Panic/Multiple shocks (118 Shocks at 34 J in about 2 hours and a half).” This information suggests that the Isoline 2CR6 Lead may have caused or contributed to a serious injury, requiring the submission of a [Medical Device Report] to FDA.”
The letter also cited problems with the testing of Sorin Biomedica’s Situs OTW leads.