FDA to Allow Liquid Morphine to Remain on the MarketApr 10, 2009 | Parker Waichman LLP
Late last month, the U.S. Food and Drug Administration (FDA) asked some medicine manufacturers to stop making 14 unapproved painkillers that are based on liquid morphine, or hydromorphine. Nine companies were given 60 days to stop manufacturing and 90 days to stop distributing the medications in order to avoid further enforcement action, reports eFluxMedia. The FDA has never approved hydromorphine for use in the U.S.
This week, the FDA said the medicine will remain on the market until such time as an approved or equivalent version or therapy can replace the existing medication, said eFluxMedia, noting that the agency’s change of heart followed complaints from many physicians who treat terminally ill patients and who were concerned that banning the drug would “cause extreme suffering for many patients who are nearing the end of life.”
Hydromorphine is sold under the name Dilaudid, among others and is used by about two million people in the U.S., reported eFluxMedia, which noted that many claim to need such unapproved pain killers, arguing that locating approved versions is nearly, if not completely, impossible. The Associated Press (AP) said concentrated morphine can be easily administered by caregivers to quickly relieve pain by placing a few drops in the patient’s mouth and is particularly helpful for patients with swallowing difficulties.
Hydromorphine may cause respiratory distress and other serious adverse events, including death in patients, if not used properly, said eFluxMedia. “While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have a few alternatives for alleviation of their pain,” Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, quoted eFluxMedia. The AP said that the change in the FDA position was met with support by those working in hospice care and pain relief.
Throckmorton explained that hydromorphine is very concentrated; more so that other, currently approved versions of the medication, saying that the FDA believed the diluted iterations of the drug could replace the concentrated version, said the AP. But, noted Throckmorton, response from the healthcare community “helped us understand" that some patients need the concentrated form of the drug, according to the AP and that the medication is essential for some near-death patients, said Reuters.
The diluted version, said the AP, needs more liquid, which could cause choking in some patients. Also, the hydromorphine can be given at home instead of morphine shots, reducing costs and eliminating the need to transport seriously ill patients to hospitals for shots. Reuters noted that the medication is sold in a potent 20-milligram per milliliter strength.
The FDA sent new letters this week, advising the drug makers to continue, for now, with the manufacture and distribution of hydromorphine. According to information on the FDA's Website, the drug makers include Glenmark Generics, a unit of Glenmark Pharmaceuticals; Lannett Company; and Covidien Ltd unit Mallinckrodt.