Qualaquin™ (quinine sulphate) has only one specific FDA-approved indication. That is the treatment of uncomplicated malaria caused by Plasmodium falciparum. In the United States, this is uncommon and when it does occur the patient has generally been travelling to a malaria area. However, for a long time Qualaquin has also been given to patients who suffer from leg cramps at night.
Qualaquin is not FDA-approved for leg cramps or restless leg syndrome, but it is nevertheless, the major reason for people in the US using it. It is also not approved for the prevention of malaria, nor is oral Qualaquin approved for the treatment of complicated or severe malaria. In other words, if an uncomplicated malaria for which one would use Qualaquin were to become complicated as in cerebral malaria, then oral Qualaquin will no longer be adequate treatment.
Side Effects Which May Occur With the Use of Quinine
Quinine is not a drug to be used lightly. Its side effects can be serious, even potentially life-threatening. As with any medication, its benefits must outweigh any negatives – in other words, it must be used for the right indication only.
The adverse effects tend to happen as a group known as "cinchonism." Many people will have these symptoms at least mildly. These side effects include:
- a potentially life-threatening reduction of platelets in the blood (thrombocytopaenia), resulting in bleeding problems including into the kidneys, which can damage the kidneys. The patient may become aware of purple, brown or red spots developing on the skin (purpura), nose bleeds, other easy bleeding or blood in the urine.
- effects on the conduction in the heart, arrhythmias, hypotension, cardiogenic shock and circulatory collapse
- visual impairment, including blurring, distorted color perception, even going on to blindness
- abdominal pain, diarrhoea and vomiting
- tinnitus, hearing impairment, deafness
- disturbance to central nervous system, including headache,depressed level of consciousness, convulsions, coma
- pulmonary oedema
Safety Precautions for Quinine
Despite the previous warning given by the FDA that quinine should not be used for off-label indications like leg cramps and restless leg syndrome, this has continued to be the major reason that Qualaquin has been dispensed in the US. As such, the FDA has agreed to a Risk Evaluation and Mitigation Strategy (REMS). This involves ensuring that patients receive a Medication Guide when they collect their medication from the pharmacy, so that they are definitely informed of the risks involved in using quinine, and exactly what its indications are. The other arm of REMS is to send letters to the health care providers to ensure that they are fully aware of the risks and limited indications for the use of quinine.
If one is using Qualaquin, and any side effects do occur, they should be reported. The contact information is available with the Qualaquin.
It is unacceptable that anyone should suffer any of these severe side effects, or even possibly die, for the sake of treating leg cramps. There are other treatments available, such as calcium and magnesium tablets. Yes, the quinine works for the leg cramps and restless legs, but at such a cost? (A GP can be consulted about one's restless legs. Effective treatment is available).
Anti-malarial drugs are not child's play.They are serious drugs with serious side effects. But then malaria is a serious illness. It kills about a million people around the world annually.
References:
FDA 8 July 2010 Drug Safety Communication: New Risk Management Plan and Patient Medication Guide for Qualaquin (Quinine Sulfate) (Online)
9 July 20102008 FDA-Approved Indications for Qualaquin™(Quinine Sulfate, 324mg Oral Capsules)9 July 2010
Sally Powrie - I am a wife, mother of 5, mother-in-law of 2, grandmother of 2, general practitioner of more than 20 years standing, and for the last 4 ...
