FDA: Ameridose Recall Could Worsen Shortage of Six Life-Saving Drugs

FDA: Ameridose Recall Could Worsen Shortage of Six Life-Saving Drugs

The Food and Drug Administration has identified six life-saving injectable drugs already in short supply that may be even harder to get because of the recall of all Ameridose products. The drugs, which are on the FDA’s critical shortage list, are commonly used during surgery and to relieve pain.

Ameridose is the sister company of the Massachusetts compounding pharmacy linked to a deadly outbreak of fungal meningitis.  The recall was announced after the FDA raised concerns about a “lack of sterility assurance” at the Ameridose facility in Westborough, Massachusetts.

The recall includes thousands of drugs, creams and solutions that Ameridose distributed to hospitals and health care providers around the country. A complete list of the recalled products can be found here and on the Ameridose website.

“FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems,” the agency said in a statement. “FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall.  The recall has the potential to exacerbate one or more of these shortages.”

The six Ameridose drugs on the critical shortage list are:

Sodium Bicarbonate Injection: Commonly used in critical care settings during advanced cardiac life support. It reduces acids in the blood.

Succinylcholine Injection: A muscle relaxant used during surgery or before investigational procedures.

Atropine Sulfate Injection: Used during surgery to reduce saliva and fluid in the respiratory tract. Can also be used in an emergency to treat a slow heartbeat and as an antidote for certain types of poisons.

Bupivacaine Hydrochloride Injection: Used for local anesthesia by peripheral nerve block or in epidural spinal blocks during labor.

Lidocaine Hydrochloride Injection: A local anesthetic used to numb parts of the body during surgery, needle punctures, or insertion of a catheter or breathing tube. Also used in epidural spinal blocks during labor.

Furosemide Injection: A diuretic (water pill) that prevents the body from absorbing too much salt. Used to treat congestive heart failure, liver disease, kidney disorders and high blood pressure.

The FDA said it is working with manufacturers of the six drugs and has asked them to increase production.  If they are not able to meet demand, the FDA said it will seek to import foreign drugs, as long as the drugs are of adequate quality.

Earlier this year, a congressional committee blamed the FDA for nationwide shortages of critical drugs, saying regulatory enforcement actions against injectable drug makers had gone too far.

“The FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs,” said the report by the House Committee on Oversight and Government Reform.

According to the report, FDA warning letters to companies led to the simultaneous shutdown of four of the country’s largest manufacturers of generic injectable drugs. As a result, the production of generic injectables declined by 30 percent, worsening the shortage.

Authored by: Pat Anson, Editor