Pharma Whistle Blower

Whistleblower Cases  |  Rewards & Reports  |  cGMP Violations

Epinephrine and Atropine Shortages, Recalls and Potential Bad Products

Available only with a physician’s prescription, epinephrine is used for the emergency treatment of life-threatening allergic reactions (anaphylaxis). It is available either in injectable form (solution in a vial) or already packaged in an injector. Common U.S. brand names include Adrenaclick, Adrenalin, Adrenalin Chloride, Auvi-Q, Epipen, Epipen Jr and Twinject.

Since 2014, there has been a worldwide shortage of epinephrine. The FDA has reported on the continuing shortage by 6 manufacturers for months. As recently as September, the American Society of Health-System Pharmacists reported that shortages continue within the United States. Their report says that at least one giant pharmaceutical company, Hospira, estimates it may catch up with demand perhaps in 4Q15.

In the midst of the shortage, the FDA today announced that Sanofi US is voluntarily recalling its Auvi-Q product (epinephrine injection USP) because the products “have been found to potentially have inaccurate dosage delivery.”

The FDA says that as of Monday Sanofi received 26 reports of suspected device malfunctions. The recall couldn’t have come at a worse time.

We applaud Sanofi for recalling its product before there was any reported fatal outcomes. Given the nature of the conditions epinephrine is used to treat, a product failure could easily result in death.

Many people with life threatening allergies rely on these products. Sometimes the products are used by people who work far from healthcare – loggers and combat Paramedics and schools routinely carry epinephrine for rapid emergency use.

Shockingly, another emergency treatment this year remains on the FDA’s US-wide drug shortage list. Atropine is a life-saving treatment of poisoning by organophosphorous nerve agents and insecticides. Four generic firms, including Hospira, are listed as unable to manufacture atropine vials and pre-filled syringes. This drug is used by the US Military worldwide to treat our troops upon sudden nerve gas (sarin) attacks. Exterminators, farmers, pesticide manufacturers and shippers also carry atropine syringes. Yet another company, which sells atropine injectors under the brand names DuoDote and AtroPen, is not currently shown on the FDA’s shortage list.

As the pharma industry struggles to catch up production of epinephrine and atropine, we worry that some companies are cutting corners.

Recently we have heard rumblings within the industry of sub-potent and possibly adulterated product and API coming into the United States. It is the problem products that aren’t recalled or reported that especially scare us.

We urge anyone with information about unsafe, adulterated, subpotent, superpotent or untested epinephrine or epinephrine injectors or atropine or atropine injectors to contact us. All inquiries are confidential.

Our mission is to clean up our Pharma industry, promote patient safety and empower whistleblowers to come forward. Under the federal False Claims Act, Pharma workers with inside information about bad epinephrine or atropine products being sold in the United States are eligible for large cash awards. We can help you stop greed and earn a large award.

All inquiries are kept confidential. Still worried? Call us anonymously. Contact the Pharmaceutical Integrity Coalition at 1-202-780-9959 or via www.pharmaintegrity.com