The Food and Drug Administration has updated information on the ongoing leucovorin shortage as of 3/23/09.

Both Bedford Laboratories and Teva Pharmaceuticals are reporting manufacturing delays for leucovorin.  Spectrum Pharmaceuticals has limited supplies of Fusilev® (levoleucovorin) which is a different formulation.  Fusilev dosages are not equal to leucovorin doses and need to be used with care. Read the rest of this entry »

The Food and Drug Adminstration is requiring that manufacturers of Reglan® (metoclopramide) to add a boxed warning to its label.  Long term or high dose use can lead to tardive dyskinesia, involuntary and repetitive movements of the body, even after the drug is discontinued.

FDA will also require the development of a risk evaluation and mitigation strategy, or REMS, that will provide a medication guide for patients to explain the risk. Read the rest of this entry »

Peanut Corporation of America has revealed that it manufactured and shipped peanuts to dollar stores for retail sale.  While no peanut butter was involved, peanuts in cans and jars were distributed to 99 Cent Stuff, 99 Cents Only Stores, Dollar General, and Dollar Tree Stores, according to a news release on February 8.2009. Read the rest of this entry »

The Food and Drug Administration is increasing its requirements for safe prescription and use of pain medicines that contain opiates beginning with a meeting in early March with manufacturers.  Additional input is planned through discussions with other government agencies, the addiction and pain treatment communities, and patient advocates.

The intensive new program is designed to reduce risk of misuse or accidental overdoses of powerful pain medicines and will probably put new requirements on physicians who prescribe them, pharmacists who dispense them, and patients who need them.

Manufacturers will be required to develop Risk Evaluation and Mitigation Strategies (REMS) to ensure that benefits of using the drugs outweigh their risks. Read the rest of this entry »

The Food and Drug Administration has expanded the recall of peanut products from the Peanut Corporation of America’s plant in Blakely GA after inspectors identified additional strains of Salmonella at the facility along with poor sanitation practices.

The plant provides peanut butter and peanut paste to more than 70 food companies that manufacturer a wide variety of products from cookies to ice cream to dog food.  Hundreds of products have been voluntarily recalled by those companies.  So far, there is no evidence that any retail peanut butter is contaminated.  The Centers for Disease Control has not had reports of Salmonella infection from strains other than Typhimurium. Read the rest of this entry »