MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_01C9B909.B22E6900" This document is a Single File Web Page, also known as a Web Archive file. If you are seeing this message, your browser or editor doesn't support Web Archive files. Please download a browser that supports Web Archive, such as Microsoft Internet Explorer. ------=_NextPart_01C9B909.B22E6900 Content-Location: file:///C:/9E8BDD12/2009-4-9Newsletter.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" 9 April 2009

9 April 2009=

 =

First Artemesinin Combination Therapy (ACT) to Treat Malaria in the USA approved = by the FDA

The US Food and D= rug Administration (FDA) on April 8th approved for the first time in= the USA an artemesinin class drug (“artemether”) in combination as a ta= blet with another antimalarial drug (“lumefantrine”) that acts via an independent mechanism.  Togeth= er these two drugs are marketed as an oral tablet called “Coartem”. The manufacturer of Coartem is Novartis Pharmaceuticals in Basel, Switzerland<= /st1:country-region>.

Coartem is approv= ed for:

1.       Uncomplica= ted malaria

2.       Patients w= ho can take oral therapy (tablets).

3.       Adults and children weighing at least 11 pounds (5 kilograms).

4.       Malaria resistant to other treatments.

Coartem is not= approved for:

1.       Complicated malaria, or when intravenous therapy is needed.

2.        Prophylaxis against malaria

3.        Small children weighing less than 11 pounds (5 kilos).

In their news rel= ease posted on their website yesterday, the FDA reported that the “most co= mmon adverse reactions to Coartem shown in clinical trials in adults are headach= e, anorexia, dizziness, physical weakness (asthenia), joint pain (arthralgia) = and muscle pain (myalgia).”

Of note, the FDA states that Coartem tablets are best taken with food that contains fat, in order to maximize absorption of the drug.

On the website of Novartis, the April 8th press release on Coartem approval by the= FDA stated that: “Coartem is a fixed-dose combination of two novel antima= larials. It is a highly effective three-day malaria treatment with cure rates of over 96%...even in areas of multi-drug resistance”.

On the World Heal= th Organization (WHO) malaria website four Artemesinin Combination Therapies (ACTs) are recommended for treatment of uncomplicated P. falciparum malaria, of which Coartem (artemether-lumefantrine) is one. The other three are:

Artesunate + amodiaquine

Artesunate + mefloquine

Artesunate + sulfadoxine-pyrimethamine=

 

Overall, approval= of this ACT “Coartem” in the USA for treatment of uncompli= cated malaria should be an important addition for clinicians treating patients, particularly those returning from parts of the world with Multi-Drug Resist= ant (MDR) malaria.

 =

Daniel R. Lucey, MD, MPH

EROne Institutes, Department of Emergency Medicine<= /o:p>

Washington Hospital Center, Washington<= /span>, D.C.

Website for this posting (requires Internet Explorer): www.BePast.org

E-mail: DRL23@Georgetown.edu

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