FDA Warns Company for Dangerous Rx Promotion

FDA warns AcelRx for claims about Dsuvia (sufentanil sublingual tablet)

(RxWiki News) The US Food and Drug Administration (FDA) has issued a warning to a pharmaceutical company for its potentially dangerous marketing of an opioid.

The agency sent a warning letter to AcelRx Pharmaceuticals, Inc. because of its "false and misleading promotion" of Dsuvia (sufentanil sublingual tablet).

The FDA said it approved this opioid product with strict prescribing and administration rules. But AcelRx has undermined those rules with its suggestion that the product is easy to administer.

Dsuvia is only approved to be given to patients by health care providers in certified and medically supervised settings. Meanwhile, AcelRx, the FDA said, has suggested that Dsuvia is easy and simple to administer with this product promotion: "Tongue and Done."

False and misleading claims like this can undermine the understanding of health care providers and the public of a drug's potential risks, the FDA noted.

"It is vitally important that promotional communications be truthful and non-misleading," according to an FDA press release. "Opioid products are highly addictive controlled substances and there are serious public health risks associated with their use, including addiction, abuse, and misuse, that can lead to overdose and death."

This drug is meant to manage severe pain in adults. It is intended for use when patients may be unable to swallow medication or take pain-relieving drugs through an IV.

In the letter to AcelRx, the FDA said the company should stop any violations and submit a written response to the letter within 15 days. This response should include a plan of action to stop misleading marketing communications about Dsuvia and spread accurate safety information.

Further violations could result in FDA action, the agency noted.

Always speak with your health care provider before taking any new medication, supplement or vitamin.

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Review Date: 
March 3, 2021