A long-awaited federal advisory panel recommended Monday that drugmaker Pfizer add older adults to its high-risk blockbuster pain medication, Lyrica, a dose of which was linked to an increased risk of death.
Lyrica, previously known as Sildenafil, is used to treat postherpetic neuralgia, post-traumatic stress disorder and pain associated with cancer, rheumatoid arthritis and multiple sclerosis. It was approved by the Food and Drug Administration in 2006 and has never faced significant criticisms before this crisis. Pfizer is in the process of purchasing fellow drugmaker Allergan, the maker of Viagra.
“I am very disappointed that the panel voted ‘favorably’ on this proposed change,” said Dr. R. Gillian Uchida, director of integrative medicine at John Jay College of Criminal Justice in New York. “I believe that the public interest requires that the highest risk population not be at the bottom of the list when it comes to adjunctive therapy.”
That is because Lyrica can cause cardiovascular and pulmonary problems when it is taken by older patients who are at high risk for these complications. Many doctors report “tremendous” resistance from their patients to discontinue the drug even when taking the appropriate dose. The advisory panel called on Pfizer to conduct long-term cardiovascular outcomes testing of the drug and for counseling of both physicians and patients about the risks associated with using the medication at high dosages.
If the recommendation is approved by the FDA, the recommended dose of Lyrica would be switched from a 25mg dose to a 50mg dose for the elderly elderly and patients who already suffer from heart conditions. Lyrica is also used to treat migraines and depression. An FDA advisory panel already found the risks of higher-than-recommended doses “moderate to significant” when it was granted approval of a new syrup variation of the drug in 2015.
“While I think the subcommittee has taken a balanced approach and is supportive of additional evidence,” Dr. Hugh Coleman, a physician at North Texas Children’s Hospital, told The New York Times, “we should not compound the problem at the expense of more and more cancer patients or the suicidal patient or the diabetics who are on the ceiling, who can go up to 300mg and fail to go down even after they go down to 250mg.”
The first finding of the advisory panel, which is made up of three patient representatives, three doctors and two representatives from the drug company, is not final. The FDA is expected to issue a recommendation in October.
The Associated Press contributed to this report.