FDA Warns Painkiller May Have Too Much Hydromorphone

FDA Warns Painkiller May Have Too Much Hydromorphone

The U.S. Food and Drug Administration is warning doctors and chronic pain sufferers on its website that a powerful painkiller injection cartridge manufactured by Hospira, Inc. may contain more Hydromorphone than the 1 milliliter dose printed on its label.

Hospira initiated a voluntarily recall of a lot of the injectable painkiller after receiving two complaints that vials contained too much of the morphine-derived medicine.

Hydromorphone, which is also distributed under the brand names Dilaudid and Palladone, is a very potent opioid that is prescribed for severe chronic pain and other conditions.  It is thought to be 6-8 times more powerful than morphine.

“Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse,” Hospira said in a statement.

The hydromorphone vials were distributed between September and October, 2011, to wholesalers and a limited number of hospitals throughout 28 states and the District of Columbia. The company has asked that pain patients who have been prescribed the drug to stop using it and to contact their physician if they experience any problems.

The recall is Hospira’s second this year, according to the FDA. On April 17, the company initiated a voluntary recall of its morphine sulphate injection vials, and warned that overdoses of morphine sulphate can also be life-threatening. The recall involved drugs distributed in 10 states.

“While voluntary recalls aren’t necessarily emblematic of major (manufacturing) problems, we are concerned by the fact that both of the recent recalls involved overfilling opioid products, which is a serious FDA concern,” Jason Gerberry, a Leerink Swann analyst, told ChicagoBusiness.com.

The most recent recalled drug vials come from lot number 07547LL and have an expiration date of July 1, 2013. No adverse events or overdoses have been reported to date.

Authored by: Staff