The FDA has determined that the nausea drug metoclopramide (marketed under the trade names Reglan, Maxolon, Octamide, or generic metolopramide) has such dangerous side effects that it must now contain a "Black Box" warning. The Black Box warning is the highest level of warning required by the FDA.
Long term use or high doses of metoclopramide can cause a bizarre condition known as "tardive dyskinesia". Tardive dyskinesisa is a neurological disorder characterized by uncontrollable repetitive movements of certain body parts. These movements include repetitive grimacing, lip smacking, tongue protrusion, pursing of the lips, rapid eye blinking, and rapid movements of the arms and legs. Victims are plagued with feelings of anxiety and inner tension, and a compulsion to move. In more serious cases, victims simply cannot sit still at all. The condition may not be reversible in some individuals, and there is no treatment.
The drug companies that manufacture metoclopramide have known about this very serious side effect for a long time, but have lumped it together with far less serious side effects such as anxiety and insomnia. The FDA has now determined that the danger associated with tardive dykinesia is so significant the strongest warning possible must appear on the package.