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Lariam Legal Claims and Lawsuits
Lariam Side Effects
Lariam History: Story of Problems
FDA Warnings and Label Changes
In July 2002, the following additions were made to Lariam's product information label:
MEFLOQUINE MAY CAUSE PSYCHIATRIC SYMPTOMS IN A NUMBER OF PATIENTS, RANGING FROM ANXIETY, PARANOIA AND DEPRESSION TO HALLUCINATIONS AND PSYCHOTIC BEHAVIOR. ON OCCATIONS, THESE SYMPTOMS HAVE BEEN REPORTED TO CONTINUE LONG AFTER MEFLOQUINE HAS BEEN STOPPED. RARE CASES OF SUICIDAL IDEATION AND SUICIDE HAVE BEEN REPORTED THOUGH NO RELATIONSHIP TO DRUG ADMINISTRATION HAS BEEN CONFIRMED. TO MINIMIZE THE CHANCES OF THESE ADVERSE EVENTS, MEFLOQUINE SHOULD NOT BE TAKEN FOR PROPHYLAXIS IN PATIENTS WITH ACTIVE DEPRESSION OR WITH A RECENT HISTORY OF DEPRESSION, GENERALIZED ANXIETY DISORDER, PSYCHOSIS, OR SCHIZOPHRENIA OR OTHER MAJOR PSYCHIATRIC DISORDERS. LARIAM SHOULD BE USED WITH CAUTION IN PATIENTS WITH A PREVIOUS HISTORY OF DEPRESSION.
DURING PROPHYLACTIC USE, IF PSYCHIATRIC SYMPTOMS SUCH AS ACUTE
ANXIETY, DEPRESSION, RESTLESSNESS OR CONFUSION OCCUR, THESE MAY
BE CONSIDERED PRODROMAL TO A MORE SERIOUS EVENT. IN THESE CASES,
THE DRUG MUST BE DISCONTINUED AND AN ALTERNATIVE MEDICATION SHOULD
The most FREQUENTLY REPORTED adverse EVENTS ARE nausea, vomiting, LOOSE STOOLS OR DIARRHEA, ABDOMINAL PAIN, dizziness OR VERTIGO, LOSS OF BALANCE, AND NEUROPSYCHIATRIC EVENTS SUCH AS HEADACHE, SOMNOLENCE, AND SLEEP DISORDERS (INSOMNIA, ABNORMAL DREAMS). THESE are USUALLY mild and may decrease DESPITE CONTINUED USE.
OCCASIONALLY, MORE SEVERE NEUROPSYCHIATRIC DISORDERS HAVE BEEN REPORTED SUCH AS: SENSORY AND MOTOR NEUROPATHIES (INCLUDING PARESTHESIA, TREMOR AND ATAXIA), CONVULSIONS, AGITATION OR RESTLESSNESS, ANXIETY, DEPRESSION, MOOD CHANGES, PANIC ATTACKS, FORGETFULNESS, CONFUSION, HALLUCINATIONS, AGGRESSION, PSYCHOTIC OR PARANOID REACTIONS AND ENCEPHALOPATHY. RARE CASES OF SUICIDAL IDEATION AND SUICIDE HAVE BEEN REPORTED THOUGH NO RELATIONSHIP TO DRUG ADMINISTRATION HAS BEEN CONFIRMED.
OTHER INFREQUENT adverse events INCLUDE:
Cardiovascular DISORDERS: circulatory disturbances (hypotension, hypertension, flushing, syncope), tachycardia or palpitation, bradycardia, irregular pulse, extrasystoles, A-V BLOCK, and other transient cardiac conduction alterations.
Skin DISORDERS: rash, exanthema, erythema, urticaria, pruritus, hair loss, ERYTHEMA MULTIFORME, AND STEVENS-JOHNSON SYNDROME.
Musculoskeletal DISORDERS: muscle weakness, muscle cramps, myalgia, AND arthralgia.
OTHER symptoms: VISUAL DISTURBANCES, VESTIBULAR DISORDERS INCLUDING TINNITUS AND HEARING IMPAIRMENT, DYSPNEA, asthenia, malaise, fatigue, fever, SWEATING chills, DYSPEPSIA AND loss of appetite.
It is suspected that Roche U.S.A. has been aware of Lariam's dangerous side effects for years. The United Press International, in conducting a six-month investigation of Lariam, reported the following:
[T]housands of pages of internal documents spanning a decade, Hoffmann-La Roche tracked increasing reports of suicides, suicidal behavior and other mental problems among Lariam users. A review of four years of reports filed to the FDA found 11 suicides attributed to Lariam, and one expert on drug side effects said he believes the number easily could be 100 times higher.
Scores of Peace Corps volunteers are coming forward saying that during the past 12 years, they suffered crippling paranoia, anxiety, hallucinations, memory loss, suicidal behavior and physical ailments they attributed to Lariam. Many volunteers said the problems had persisted for years. Sen. Chris Dodd, D-Conn., who chairs the committee overseeing the Peace Corps and is a former volunteer, called for an independent medical investigation of the matter based on the UPI report.