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The anti-malarial drug Mefloquine (aka Lariam, Mephaquin or Mefliam) is known to frequently induce strong neurologic side effects.

I have heard a number of times that this drug would fail to get regulatory approval, if it were introduced today.

For example, the claim can be found in this (Swiss-German) article, which appeared in a Ktipp, a Swiss consumer protection magazine.

Heute würde Lariam nicht mehr zugelassen, ist Experte Ashley Croft überzeugt. Kürzlich wies er nach: Vor der Zulassung wurde Lariam fast nur an Einheimischen getestet, die an Malariaerreger gewöhnt sind - nicht aber an Touristen. Die Behörden drückten ein Auge zu. Dies sei «verantwortungslos», so Croft.

Erst mehrere Jahre nach der Zulassung machte Roche Studien mit Touristen. Die Ergebnisse waren niederschmetternd. Eine Studie kam zum Schluss: Über drei Viertel bekamen Probleme mit den Nerven oder der Psyche. Die meisten waren harmlos, etwa Kopfschmerzen oder schlechte Träume. Einige Teilnehmer litten aber auch an Depressionen oder Panikattacken.

Laut Rudolf Stoller von der Schweizer Zulassungsstelle Swissmedic war Lariam damals eine «wichtige Alternative» gegen Malaria. «In der Zwischenzeit», so Stoller, «sind die Anforderungen an die Zulassung eines Medikamentes aber tatsächlich höher geworden.»

Basic English translation:

Today Lariam would no longer be approved, expert Ashley Croft is convinced. Recently he showed: Before admission Lariam was almost solely tested on locals, who are accustomed to the malaria pathogen - but not on tourists. The authorities turned a blind eye. This was "irresponsible", says Croft.

It was not until several years after the admission that Roche made studies involving tourists. The results were devastating. One study concluded: More then three-quarters developed problems with nerves or psyche. Most were harmless, such as headaches or bad dreams. However, some participants also suffered from depression or panic attacks.

Taken from Rudolf Stoller from the swiss Admission Board Swissmedic: Back then Lariam was an "important alternative" against malaria. "In the meantime", says Stoller, "the requirements for approval of a drug have actually become higher."

Can this be verified?

  • I used a basic Google translate, to get the gist. Any (Swiss) German speakers care to edit it to make more sense? – Oddthinking Oct 29 '14 at 13:53
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    Welcome to Skeptics!. The question doesn't specify a jurisdiction. The local laws for drug acceptance are likely to vary. Which region is the question about (ideally, with corresponding claims)? – Oddthinking Oct 29 '14 at 13:55
  • Let's assume Swiss jurisdiction, since the source is a Swiss consumer protection magazine. – ChrisW Oct 29 '14 at 14:07
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    Also important to note: "able to be approved" says nothing about worth of a drug. The risk of side effects of a drug might very well be more than a modern regulator is willing to put approval on for political reasons, yet drastically less than the risk from the disease. – user5341 Nov 6 '14 at 14:26
  • This is a troublesome question. The hypothetical of whether it would be approved under current laws is not a statement of fact, but a legal opinion. You quote an opinion of someone with suitable expertise. How could we provide an answer that is more definitive? – Oddthinking Aug 19 '15 at 1:31

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