U.S. Drug Shortages

February 21, 2012 by staff 

U.S. Drug Shortages, The U.S. Food and Drug Administration said Tuesday it has approved new suppliers for two crucial cancer drugs, easing critical shortages – at least for the time being – that have patients worried about missing life-saving treatments.

The FDA said it will temporarily allow importation of a replacement for Doxil, a drug for ovarian and other cancers that hasn’t been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories and its complex in Bedford, Ohio, possibly for a year, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

The methotrexate shortage doesn’t seem to be a problem in Canada, however, which has different suppliers of the drug than are used in the U.S.

Drugs shortages increase dramatically in U.S.
The FDA increasingly has been able to prevent drug shortages by getting advance notice from manufacturers, with 195 shortages prevented in 2011, mostly late in the year after U.S. President Barack Obama issued an executive order giving FDA additional powers to address the shortages. Still, about 280 drugs are in short supply.

“A drug shortage can be a frightening prospect for patients,” Dr. Margaret A. Hamburg, FDA commissioner, said in a statement.

“Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs, which are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.

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