Articles Posted in drug recall

Carcinogen in Heartburn Drug May Build in Storage, Lab Finds

News reports the heartburn medicine Zantac (ranitidine) “appears to produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to a testing laboratory that’s urging the U.S. Food and Drug Administration to recall all forms of the widely used product.” Since at least September, the FDA “has been monitoring the presence of” a toxic chemical called NDMA that has been “found in some samples of Zantac, which is also sold in generic versions.” New testing “by an Alameda, California-based independent laboratory called Emery Pharma found that a combination of heat and time can raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers.”

Numerous manufacturers have already pulled products from pharmacy shelves, including Sanofi, which makes the brand-name version of Zantac. A leading oncology hospital, New York’s Memorial Sloan Kettering Cancer Center, has also said it will no longer offer the drug to patients while it reviews the risk. The FDA has yet to push for any widespread recall.

A “pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products.” According to “a statement from the United States Food and Drug Administration, some CVS Health and Equate brand liquid infants’ ibuprofen products may contain a higher concentration of ibuprofen than the label suggests.”

All of the bottles were labeled as a “Concentrated Ibuprofen Oral Suspension, USP” with a concentration of 50 mg of ibuprofen per 1.25 mL. The products were packaged in 0.5 oz and 1 oz bottles.

The FDA says some infants may be susceptible to the effects of ibuprofen, including kidney damage. However, most children can tolerate doses of ibuprofen up to 700 percent of the recommended amount.

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers and healthcare providers began to prescribe them at greater rates.  Increased prescription of opioid medications led to widespread misuse of both prescription and non-prescription opioids before it became clear that these medications could indeed be highly addictive.

A lawsuit was filed by the State of Oklahoma for what became “the opioid crisis” plaguing the nation. Several other states and municipalities have followed suit.

Following a seven-week trial this summer, Judge Thad Balkman ruled Johnson & Johnson and its subsidiaries helped fuel the opioid crisis with an aggressive and misleading marketing campaign that overstated how effective the drugs were for treating chronic pain and understated the risk of addiction. Oklahoma Attorney General prosecuted the lawsuit arguing that opioid overdoses killed 4,653 people in Oklahoma from 2007 to 2017.  The trial led to the judge ordering consumer products giant Johnson & Johnson to pay $572 million to help address the state’s opioid crisis. The judge then reduced the amount to $465 million.

Reuters  reports that Johnson & Johnson CEO Alex Gorsky “declined to appear at a U.S. congressional hearing set for Tuesday on the safety of the company’s Baby Powder and other talc-based cosmetics.” However, J&J spokesman Ernie Knewitz said that the House of Representatives Subcommittee on Economic and Consumer Policy rejected J&J’s offers to send a talc testing expert or a consumer products executive. Members of the House are disappointed in Gorsky’s lack of cooperation with regards to the products believed to contain asbestos.

“Gorsky has played a lead role in J&J’s efforts to reassure consumers and investors that its talc powders are safe and asbestos free. Last year, he issued a statement vouching for the safety of the products after a jury issued a $4.69 billion verdict in favor of 22 women who sued over allegations their ovarian cancers were caused by J&J powders.”

Reuters reports “the U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday.”

Metformin is a standard medication during early stages of type 2 diabetes. It helps control high blood sugar and is marketed under a number of brand names, including Fortamet and Glucophage.

This comes as “part of the agency’s broader push to investigate a range of drugs for the presence of the carcinogen, known as N-nitrosodimethylamine (NDMA), with popular heartburn medication Zantac being recalled this year for fear it contained NDMA.”

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