Drug shortages could be worsened by Ameridose recall, FDA says

Federal agencies warned Thursday night that the problems with two compounding pharmacy companies in New England have shown up in other drugs produced by one of them and the recalls might lead to further shortages of six drugs.

The New England Compounding Center is at the center of the national fungal meningitis outbreak. The Centers for Disease Control and Prevention reports 386 cases in 19 states with 28 deaths.

Ameridose is a second company with the same corporate parent, and after the FDA found problems there, it recalled all of its products.

The CDC and FDA said that product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on Oct. 6.

The FDA warned that six drugs produced by Ameridose, which recalled all its products Wednesday, were already on the FDA's list of drugs in short supply.

According to the FDA, the Ameridose recall could exacerbate one or more of the shortages of these drugs:

• Sodium bicarbonate injection

• Succinylcholine injection

• Atropine sulfate injection

• Bupivacaine hydrochloride injection

• Lidocaine hydrochloride injection

• Furosemide injection

The FDA said it is doing the following things to help alleviate the potential shortages:

• FDA is working with manufacturers for these 6 drugs, requesting that they ramp up production if they are willing and able to do so.

• For any manufacturers for these six drugs that may be experiencing manufacturing/quality problems, FDA is offering assistance, where appropriate, to help address these problems to enable those manufacturers to manufacture shortage drug products that are safe and high quality.

• If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, FDA explores companies that are willing and able to import foreign drugs to address the shortage in the U.S. In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.

• As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.

• FDA is identifying any additional manufacturers willing to initiate or increase production.

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