CDC HCQ Fact Sheet (Exhibit 12) — AAPS v. FDA

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EXHIBIT 12 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 8-14 filed 06/22/20   PageID.284   Page 1 of 3

CS237187-C
Medicines for the Prevention of Malaria While Traveling 
Hydroxychloroquine (Plaquenil™)
What is hydroxychloroquine? 
Hydroxychloroquine (also known as 
hydroxychloroquine sulfate) is an arthritis medicine 
that also can be used to prevent malaria. It is 
available in the United States by prescription only.  
It is sold under the brand name Plaquenil and it 
is also sold as a generic medicine. It is available in 
tablets of 155mg base (200mg salt). 
You should know that the 155mg base tablet is 
the same as the 200mg salt tablet.  It is just two 
different ways of describing the same thing.  
Hydroxychloroquine can be prescribed for either 
prevention or treatment of malaria. 
This fact sheet provides information about its use 
for the prevention of malaria infection associated 
with travel. 
Center for Global Health
Division of Parasitic Diseases and Malaria
Who can take hydroxychloroquine?
Hydroxychloroquine can be prescribed to adults 
and children of all ages. It can also be safely taken by 
pregnant women and nursing mothers. 
Who should not take 
hydroxychloroquine?
People with psoriasis should not take 
hydroxychloroquine.  
How should I take 
hydroxychloroquine?
Both adults and children should take one dose of 
hydroxychloroquine per week starting at least 1 week 
before traveling to the area where malaria transmission 
occurs. They should take one dose per week while 
there, and for 4 consecutive weeks after leaving.  
The weekly dosage for adults is 310mg base (400mg salt). 
Your doctor will have calculated the correct weekly 
dose for your child based on the child’s weight. The 
child’s dose should not exceed the adult dose of 
310mg base (400mg salt) per week
Where can I buy 
hydroxychloroquine? 
Antimalarial drugs are available in the United States 
by prescription only. Medicines should be obtained 
at a pharmacy before travel rather than in the 
destination country. Buying medications abroad 
has its risks: the drugs could be of poor quality, 
contaminated, or counterfeit and not protect you 
against malaria.
In what parts of the world can 
hydroxychloroquine be used for 
prevention of malaria in travelers?
Hydroxychloroquine can only be used in places 
where chloroquine (a related medicine) is still 
effective. There are only a few places left in the 
world where hydroxychloroquine is still effective 
including parts of Central America and the 
Caribbean. 
CDC keeps track of all the places in the world where 
malaria transmission occurs and which malaria 
drugs that are recommended for use in each place. 
This information can be found using the malaria 
map on the CDC website: http://www.cdc.gov/
malaria/map/index.html.
This map shows an approximation of the parts of the world where malaria 
transmission occurs. For more detailed information about the occurrence of malaria 
transmission in specific countries, please use the interactive Malaria Map Application.
Malaria transmission 
occurs throughout
Malaria transmission 
occurs in some parts
Malaria transmission is 
not known to occur
Case 1:20-cv-00493-RJJ-SJB   ECF No. 8-14 filed 06/22/20   PageID.285   Page 2 of 3

Page 2 of 2
Hydroxychloroquine (Plaquenil™)
Malaria is a serious disease that can 
cause death if not treated right away. 
It is caused by a parasite that can 
infect a certain type of mosquito 
which feeds on humans.
About 1,500 cases of malaria are 
diagnosed in the United States each 
year almost all in travelers to parts of 
the world where malaria occurs.
Will hydroxychloroquine interact 
with my other medications?
Some other drugs can interact with 
hydroxychloroquine and cause problems. Your 
doctor is responsible for evaluating the other 
medicines you are taking to ensure that there 
are no harmful interactions between them 
and hydroxychloroquine. In some instances, 
medicines can be adjusted to minimize the 
interaction. You can also ask your pharmacist to 
check for drug interactions. 
What are the potential side 
effects of hydroxychloroquine?
Hydroxychloroquine is a relatively well tolerated 
medicine. The most common adverse reactions 
reported are stomach pain, nausea, vomiting, 
and headache. These side effects can often be 
lessened by taking hydroxychloroquine with 
food. Hydroxychloroquine may also cause 
itching in some people.
All medicines may have some side effects. 
Minor side effects such as nausea, occasional 
vomiting, or diarrhea usually do not require 
stopping the antimalarial drug. If you cannot 
tolerate your antimalarial drug, see your 
health care provider; other antimalarial drugs 
are available.
Other considerations  
•	 A good choice for longer trips because 
you only have to take the medicine once 
per week.
•	 Overdose of antimalarial drugs, particularly 
hydroxychloroquine, can be fatal. Medication 
should be stored in childproof containers 
out of the reach of infants and children.
•	 Some people are already taking 
hydroxychloroquine regularly for other 
medical conditions such as arthritis. In those 
instances, they may not need to take an 
additional medicine to prevent malaria. Your 
doctor can advise you. 
How long is it safe to use 
hydroxychloroquine?
CDC has no limits on the use of 
hydroxychloroquine for the prevention of 
malaria. When hydroxychloroquine is used 
at higher doses for many years, a rare eye 
condition called retinopathy has occurred. 
People who take hydroxychloroquine for 
more than five years should get regular 
eye exams. 
Check out the CDC malaria website at 
www.cdc.gov/malaria 
Health-care providers needing assistance 
with diagnosis or management of 
suspected cases of malaria should call the 
CDC Malaria Hotline:  770-488-7788 or 
855-856-4713 toll-free (M-F, 9am-5pm, 
eastern time). 
Emergency consultation after hours, call: 
770-488-7100 and request to speak with 
a CDC Malaria Branch clinician. 
For more information: 
Prevent Malaria
•	 Take an antimalarial drug. 
•	 Prevent mosquito bites. 
•	 If you get sick, immediately seek 
professional medical care. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 8-14 filed 06/22/20   PageID.286   Page 3 of 3

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