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Delaware Health Alert Network #263

January 18, 2012 3:50pm


Health Alert
SHORTAGE OF ALINIA (NITAZOXANIDE) FOR TREATMENT OF CRYPTOSPORIDIOSIS


The Division of Public Health (DPH) alerts the medical community about a shortage of Alinia (nitazoxanide).

CDC (Centers for Disease Control and Prevention) has received multiple inquiries from health care providers across the United States about the inability to fill prescriptions for Alinia (nitazoxanide).Alinia is the only U.S. Food and Drug Administration–approved drug to treat cryptosporidiosis in immunocompetent patients.

Romark Laboratories is in the process of changing sites where Alinia (nitazoxanide) is manufactured. Alinia suspension is currently not available. If Alinia tablets are needed but unavailable through wholesalers or pharmacies, Romark Laboratories can ship single bottles of tablets directly to a pharmacy. To make shipping arrangements, please call 813-282-8544. Romark Laboratories anticipates that it will begin shipping new Alinia suspension during the week of January 16, 2012 and that wholesalers will be re-stocked with new supplies of Alinia tablets in early February 2012.

Reporting of Cryptosporidiosis:

Cryptosporidiosis is a reportable disease in Delaware. Laboratories and healthcare providers are required to report any diagnosed case to DPH, Bureau of Epidemiology (1-888-295-5156 or 1-302-744-1033) within 48 hours by telephone, fax or electronic method. Information tracked includes date of onset, method of diagnosis, underlying medical conditions, occupation, travel history and any known exposures within 10 days prior to the onset of illness.

About Cryptosporidiosis:

Cryptosporidium (Crypto) is a microscopic parasite that causes the diarrheal disease cryptosporidiosis. Both the parasite and the disease are commonly known as "Crypto."

There are many species of Cryptosporidium that infect humans and animals. The parasite is protected by an outer shell that allows it to survive outside the body for long periods of time and makes it very tolerant to chlorine disinfection.

The most common symptom of cryptosporidiosis is watery diarrhea. Other symptoms include: stomach cramps or pain, dehydration, nausea, vomiting, fever and weight loss. Some people with Crypto will have no symptoms at all. While the small intestine is the site most commonly affected, Crypto infections could possibly affect other areas of the digestive tract or the respiratory tract.

Symptoms of cryptosporidiosis generally begin 2 to 10 days (average 7 days) after becoming infected with the parasite. In persons with healthy immune systems, symptoms usually last about 1 to 2 weeks. The symptoms may go in cycles in which patient may seem to get better for a few days, then feel worse again before the illness ends.

Cryptosporidium live in the intestine of infected humans or animals. An infected person or animal sheds Crypto parasites in the stool. Millions of Crypto germs can be released in a bowel movement from an infected human or animal. Shedding of Crypto in the stool begins when the symptoms begin and can last for weeks after the symptoms (e.g., diarrhea) stop. Cryptosporidium may be found in soil, food, water, or on surfaces that have been contaminated with the feces from infected humans or animals. Cryptosporidium is not spread by contact with blood.

Cryptosporidium can be spread:

  • By putting something in mouth or accidentally swallowing something that has come into contact with stool of a person or animal infected with Crypto.
  • By swallowing recreational water contaminated with Crypto. Recreational water is water in swimming pools, hot tubs, Jacuzzis, fountains, lakes, rivers, springs, ponds, or streams. Recreational water can be contaminated with sewage or feces from humans or animals.
  • By swallowing water or beverages contaminated with stool from infected humans or animals.
  • By eating uncooked food contaminated with Crypto.
  • By touching the mouth with contaminated hands. Hands can become contaminated through a variety of activities, such as touching surfaces (e.g., toys, bathroom fixtures, changing tables, diaper pails) that have been contaminated by stool from an infected person, changing diapers, caring for an infected person, and handling an infected cow or calf.
  • By exposure to human feces through sexual contact.

Diagnosis:

Diagnosis of cryptosporidiosis is made by examination of stool samples. Because detection of Cryptosporidium can be difficult, patients may be asked to submit several stool samples over several days. Most often, stool specimens are examined microscopically using different techniques (e.g., acid-fast staining, direct fluorescent antibody [DFA], and/or enzyme immunoassays for detection of Cryptosporidium sp. antigens).

Molecular methods (e.g., polymerase chain reaction – PCR) are increasingly used in reference diagnostic labs, since they can be used to identify Cryptosporidium spp. at the species level.

Tests for Cryptosporidium are not routinely done in most laboratories; therefore, health care providers should specifically request testing for this parasite.

Treatment:

Most people who have healthy immune systems will recover without treatment. Diarrhea can be managed by drinking plenty of fluids to prevent dehydration. People who are in poor health or who have weakened immune systems are at higher risk for more severe and prolonged illness. Young children and pregnant women may be more susceptible to dehydration resulting from diarrhea and should drink plenty of fluids while ill. Rapid loss of fluids from diarrhea may be especially life threatening to babies. Therefore, parents should talk to their health care providers about fluid replacement therapy options for infants.

Anti-diarrheal medicine may help slow down diarrhea, but a health care provider should be consulted before such medicine is taken. Nitazoxanide has been FDA-approved for treatment of diarrhea caused by Cryptosporidium in people with healthy immune systems and is available by prescription. However, the effectiveness of nitazoxanide in immunosuppressed individuals is unclear.

Additional Information:

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