recall

Glass particles found in injectable cancer drugs; massive FDA recall issued

Friday, July 20, 2012 by: J. D. Heyes
Tags: cancer drugs, glass, particles

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(NaturalNews) Having to deal with the mental and physical pains of cancer is bad enough, but it's worse when you have to fear the medicine used to treat it.

Hospira, the world's leading provider of injectable drugs and infusion technologies, announced in June that it will recall four of its cancer drugs and other medications both in the United States and from around the world - the fourth month in a row the company has had to warn the healthcare industry of issues related to its products.

In a joint release with the Food and Drug Administration, Hospira blamed the glass supplier for the injectables in recalling 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, which were shipped between September 2011 and April of this year. According to the release, vials of these drugs have been discovered with "visible particles embedded in the glass located at the neck of the vial."

Glass particles in the medicine, in other words.

"In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms," said the joint statement.

Drugs in U.S., abroad recalled

Daniel Rosenberg, a spokesman for Hospira, told the Pharma Web site FiercePharmaManufacturing, in an email: "Hospira has not received any reports of adverse events related to these lots. The root cause is a supplier glass defect, and we have taken corrective action to prevent this from occurring again. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall."

In addition, the company has said recently it was recalling drugs from a number of other nations ranging from Canada to Norway, Australia and Vietnam, reports said. Those global recalls don't include cytarabine; however, but do include other drugs such as heparin, desferrioxamine, oxaliplatin, fluorouracil and epirubicin.

In his email, Rosenberg said it's possible that some countries could experience temporary shortages of the drugs but added, "In most cases, we will have replacement stock available, and we don't anticipate major disruptions for the majority of our overseas customers."

The Pharma Web site noted that shortages stemming from drug-maker manufacturing problems have been a major issue over the past couple of years, particularly at Hospira, which the site says "has found itself in the middle of it." The company is one of four other generic medication producers named in a House committee report recently that are linked to grave shortages of drugs in the United States, due to FDA actions requiring each to correct quality control issues on their production lines.

Hospira has also borne the brunt of a new legal strategy: Patients or their families filing suit against drug makers who say a shortage of medications they were taking worsened their medical conditions and, in some cases, even led to death.

History of manufacturing problems

For example, FiercePharmaManufacturing said, when a Tampa, Fla., woman discovered she could not get Hospira's Aquasol A - or vitamin A palmitate - she sued the company, claiming she became blind in one eye because she relied on the drug to correct a vitamin A deficiency.

In that case; however, a federal judge dismissed her claim, saying the company was not liable for failing to keep a sufficient reserve supply of the drug to avoid unforeseen shortages due to production problems.

To its credit, Hospira has spent months upgrading production facilities in Austin, Texas, as well as Clayton and Rocky Mount, N.C., after the FDA issued warnings about problems there.

Still, problems have continued. In April and May 2012, Hospira was forced to recall single lots of overfilled injection cartridges which contained morphine, a powerful painkiller, and hydromorphine.

"In June; however, it acknowledged that the problem was far more extensive than first believed and could affect as many as 280 lots of 15 different Carpuject products," FiercePharmaManufacturing reported. "But instead of yanking the products out of the supply chain, which the FDA said would lead to immediate shortages of some products, healthcare providers were alerted that they needed to visually inspect the products and adjust doses if cartridges were overfilled."

Sources:

http://www.fiercepharmamanufacturing.com

http://www.reuters.com

http://www.fda.gov/Safety/Recalls/ucm311971.htm

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