The Food and Drug Administration on Wednesday urged doctors to prescribe the popular antidepressant Effexor in the smallest possible quantities to reduce the risk of overdose.
Wyeth, the maker of Effexor or venlafaxine HCI, and the FDA had reports of overdoses occurring in some patients, mostly in combination with alcohol or other drugs, the agency said in a statement.
“Health care professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose,” the FDA said.
The reported overdoses resulted in death or symptoms such as rapid heartbeat, coma, seizures, vomiting and vertigo, Wyeth said in a letter it sent to doctors and health care providers.
“Epidemiological studies have shown that venlafaxine-treated patients have a higher pre-existing burden of suicide risk factors than SSRI-treated patients,” the Wyeth letter said.
SSRIs — selective serotonin reuptake inhibitors — are another class of antidepressants that include such drugs as Celexa, Prozac, Paxil and Zoloft.
The letter did not disclose how many overdose cases had been reported. It urged doctors to report any adverse reactions to Effexor to the company or to the FDA.