FDA Drug Warnings and Communications
FDA Issues Warning Over Cantrell Drug Manufacturing Practices
In further evidence of a growing trend of crackdowns on unsafe drug manufacturing practices, the United States Food and Drug Administration (FDA) announced March 2 warnings over serious deficiencies in quality and sterility assurance for products produced by Cantrell Drug Company of Little Rock, Arkansas. The warning comes as a result of FDA concerns over “serious deficiencies” in the company’s drug compounding practices that result in a lack of sterility assurance, issues that could lead to contamination resulting in “serious and life-threatening injury or death.”
In accordance with issuance of the warning, the FDA also announced it has initiated legal proceedings aimed at stripping Cantrell of its ability to manufacture and distribute pharmaceutical drugs in the United States until the company is certified to be in compliance with existing rules and regulations. The U.S. Department of Justice (DOJ), in coordination with the FDA, has filed with the U.S. District Court in the Eastern District of Arkansas a request for preliminary injunction against Cantrell, asking the court “to order Cantrell to stop manufacturing, processing, packing, labeling, holding and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C) and its implementing regulations.” The DOJ and FDA also request the court to demand that Cantrell recall all of its non-expired drug products currently on the market.
According to the company website, Cantrell Drug Company touts itself as “pharmaceutical outsourcing specialists” and advertises for sale drug products such as ephedrine sulfate, glycopyrrolate, lidocaine, and morphine sulfate. Because other drug companies outsource aspects of their own drug production to Cantrell, it may sometimes be unclear to consumers when a company like Cantrell has been involved in the manufacture of the medications they are taking.
The FDA action involving Cantrell demonstrates not only the worrying extent to which drug-manufacturing facilities—even those right here in the United States—often fail to meet basic standards for safe and sterile pharmaceutical production, but also the common practice of outsourcing some or all aspects of drug manufacturing to third parties, oftentimes without the consumer’s knowledge.
If you have been injured by an unsafe drug or one produced in an unsterile environment, the expert attorneys at TheLawFirm.com are standing by to offer a free consultation about your legal rights.
FDA Releases Drug Safety Communication About Biaxin Use
On February 22, the United States Food and Drug Administration (FDA) released a Drug Safety Communication regarding the antibiotic clarithromycin, which is sold under the brand name Biaxin. The communication warned that a comprehensive new 10-year study had demonstrated an increased risk of death in individuals with coronary heart disease who had been prescribed a two-week clarithromycin treatment. The study was not able to explain the reason why taking clarithromycin resulted in a greater number of deaths than did taking a placebo, but the FDA advises healthcare professionals to take the information into account when prescribing clarithromycin to patients with heart disease.
Clarithromycin is a widely used antibiotic that is typically prescribed to treat infections of the skin, ears, sinuses, and lungs. While the evidence of an increased risk of death in patients having heart disease who take clarithromycin has been mixed across observational studies, the recent CLARICOR trial, which was prospective and placebo-controlled, offers, according to the FDA, “the strongest evidence of the increase in risk.”
The FDA advises patients to tell their healthcare professionals if they have heart disease when being prescribed an antibiotic.
Stay tuned to TheLawFirm.com for the latest FDA updates, including drug recalls and warnings. If you have suffered harm as a result of taking an unsafe medication, contact the expert attorneys at TheLawFirm.com now for a free consultation regarding your legal rights. Don’t delay, the law places strict time limits on your ability to bring a claim.
FDA Issues New Drug Warnings for Deferasirox
On February 16, the United States Food and Drug Administration (FDA) issued drug safety labeling changes for brand-name drugs containing deferasirox, an iron chelator used to minimize chronic iron overload in patients being treated with regular blood transfusions for long-term conditions. The labeling changes, which cover drugs sold by Novartis under the brand names Exjade, Jadenu, and Jadenu Sprinkle, add language to the Warnings and Precautions section stating a risk of Drug Reaction with Eosinophilia and System Symptoms (DRESS), a potentially life-threatening condition.
DRESS is a rare but sometimes fatal hypersensitivity reaction brought on by exposure to certain drugs. Its symptoms and complications include skin eruption, hematologic abnormalities (eosinophilia, atypical lymphocytosis), lymphadenopathy, and issues with internal organs such as the liver, kidney, and lungs. Following initial treatment, patients may experience relapses of DRESS despite discontinuing exposure to the drug in question.
When it was originally introduced in 2005, deferasirox was the first drug of its kind to be approved for usage in the United States. Deferasirox is taken orally, and its chemical structure allows it to bond with iron atoms and then subsequently remove the iron from the body through the feces. The drug already had been associated with renal failure and cytopenias.
Have you or someone you know suffered from DRESS after taking a drug containing deferasirox? If so, contact the expert attorneys at TheLawFirm.com for a free consultation about your legal rights.