News Scan for Jun 13, 2013

Drug for MDR-TB
Doxycycline shortage
Compounding pharmacy probe
Polio in Somalia and Kenya

WHO issues guidance on use of new TB agent in multidrug-resistant cases

The World Health Organization (WHO) today issued interim policy guidance on the use of bedaquiline, a new tuberculosis (TB) drug, for treating multidrug-resistant TB (MDR-TB).

The agency said there is considerable interest in using bedaquline for treating MDR-TB, but information is limited because it has completed only phase 2b trials for safety and efficacy. Bedaquline is the first TB drug with a novel mechanism of action in more than 40 years and was approved by the US Food and Drug Administration (FDA) last December.

The WHO said five conditions should be met if the drug is used to treat MDR-TB patients: Providers should:

  1. Closely monitor treatment
  2. Refrain from using the drug in children and pregnant women and use it only with special caution in those over 65 and adults with HIV 
  3. Ensure that patients give informed consent
  4. Follow the WHO's general principles for MDR-TB treatment
  5. Take active measures to detect adverse drug reactions.

Jun 13 WHO statement


CDC urges clinicians to plan for doxycycline shortage

A shortage of certain forms of the antibiotic doxycycline continues for some manufacturers, and while providers should still be able to get it, some may need to find other ways of getting the drug to avoid possibly fatal treatment delays for rickettsial infections, the US Centers for Disease Control and Prevention (CDC) said yesterday.

In a Health Alert Network (HAN) advisory to clinicians, the CDC said it first reported the shortage of some forms of doxycycline and the unavailability of tetracycline due to increased demand and manufacturing issues on Jan 18. Doxycycline is the recommended treatment for rickettsial infections and some sexually transmitted diseases and is one of the medications used to treat Lyme disease and malaria.

The CDC warned that although chloramphenicol is sometimes suggested as a possible alternative treatment for rickettsial disease, its use carries a higher risk of fatal outcomes and isn't recommended unless a patient has life-threatening contraindications to taking doxycycline.

One manufacturer is reporting a doxycycline shortage, and it's unclear when it will be fully available, though the FDA suggests the supply could be restored by September.

The FDA also notes that there is no shortage of intravenous doxycycline hyclate or the oral suspension doxycycline calcium typically used in pediatrics settings.
Jun 12 CDC HAN advisory


Probe of Tennessee compounder identifies microbes, facility problems

The FDA today said its tests on unopened vials from two lots of recalled steroid injections identified bacterial species, including different types of BacillusRoseomonas, and Acinetobacter, and fungal species including AlternariaCladosporium, and Penicillum, according to a drug safety update.

Tests on samples for other lots and other products made by Main Street Family Pharmacy, a compounder based in Newbern, Tenn., are under way.

Yesterday the FDA released its inspection report for the facility, which cited numerous problems, including lack of validation for the company's sterilization process and equipment and utensils not being cleaned and maintained properly.

A worker was observed not wearing appropriate protective clothes, and the company didn't have procedures in place to prevent contamination. Also, the company didn't do potency testing on completed batches and had no stability testing program. Overall, inspectors noted 26 observations.

The CDC has so far linked 25 suspected skin and soft-tissue infections to injectable methylprednisolone acetate made by the company. Efforts are ongoing to contact patients to see if they were infected after receiving the recalled steroids.

The CDC said today that pharmacy records indicate 17 states received the products: Alabama, Arkansas, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Montana, Mississippi, New Mexico, New York, North Carolina, Oklahoma, South Carolina, Tennessee, and Texas. Though Montana and California received the products, they were not administered to patients, the agency said.
Jun 13 FDA drug safety update
Jun 13 CDC outbreak update


Fourteen polio cases reported in Somalia and Kenya in past month

Fourteen wild poliovirus type 1 (WPV1) cases have been detected in Somalia and Kenya since May 9, triggering vaccination efforts and travel-related advisories, the CDC reported today.

The cases in Somalia began with one reported in Mogadishu on May 9, marking the first in the country since 2007, and eight more have been found since then, the CDC said in Morbidity and Mortality Weekly Report (MMWR).

In Kenya, five cases have been reported in the Dadaab refugee camps near the Somalia border since May 16; these are the country's first since 2011. The isolates from the two countries are closely related, suggesting a single introduction of virus into the region.

Local vaccination campaigns have already been carried out, and more are planned. As of Jun 11, the global tally of polio cases for 2013 was 50, compared with 67 for the same period last year.

The CDC recommends a polio booster dose for all travelers headed for Somalia, Kenya, and Ethiopia. Also, CDC guidelines say that Kenyan refugees planning to resettle in the United States must receive three doses of oral polio vaccine before they depart.
Jun 14 MMWR article

In other developments, poliovirus was found in the sewers of two more towns in Israel, Kiryat Gat and Ashdod, the Times of Israel reported yesterday.

Last week wildpoliovirus was reported in sewage in the nearby town of Rahat, and the Ministry of Health believes the newfound isolates originated there, according to the Times. Authorities said the area's water system is not contaminated, and the whole population in Rahat is being vaccinated.
Jun 12 Times story
Jun 3 CIDRAP News item on poliovirus in Israel

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