Orthopedic Alerts for Patients - Implant Recalls

Alerts and implant recalls for patients with orthopedic bone and joint conditions.

A study linked heartburn drugs called proton pump inhibitors — such as Nexium (esomeprazole) and Prilosec (omeprazole) — to increased risk of potentially serious stomach infections. The study published on Jan. 5 in the British Journal of Clinical Pharmacology followed about 565,000 adults in Tayside, Scotland. Dr. Thomas M. MacDonald and colleagues split patients into two groups: Those who used proton pump inhibitors and H2 receptor agonists — another kind of acid blocker — and a control group.

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More than half of the nearly $5 billion recovered under the federal False Claims Act during the last budget year came from the health care industry. The U.S. Department of Justice secured roughly $4.7 billion in settlements and judgments from civil cases involving fraud and false claims during the budget year that ended Sept. 30. Of that, $2.5 billion came from the health care industry, including drug companies, medical device companies, hospitals, nursing homes, laboratories and physicians.

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The U.S. Senate has passed legislation intended to speed up Food and Drug Administration drug and device approvals and “cut red tape” at the agency, but critics say it benefits the industry more than patients. The U.S. House of Representatives already approved the bill— known as the 21st Century Cures Act — and the Senate passed it on Wednesday. Now it makes its way to President Obama, who said he would sign it.

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A coalition of 20 states is suing six generic drug manufacturers, alleging they illegally conspired to inflate prices of two medications as part of an industrywide price-fixing scheme. The alleged scam, hammered out during dinners, “girls nights out” and parties, “caused a significant, lasting and ultimately harmful rippling effect in the United States healthcare system…” the lawsuit alleges. The suit stems from an investigation Connecticut launched in July 2014 amid outrage over “unexplained and suspicious price increases” for generic drugs.

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Proton pump inhibitors (PPIs) — a class of heartburn drugs that includes Nexium, Prilosec and Prevacid — may increase the risk of stroke, according to research presented at the American Heart Associations’ Scientific Sessions 2016. Dr. Thomas Sehested of the Danish Heart Foundation in Copenhagen Denmark — the study’s lead author — presented his findings at the Scientific Sessions held on Nov. 12 to 16 in New Orleans, Louisiana. PPIs are some of the most commonly used drugs in the U.S.

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Bristol-Myers Squibb has reached a nearly $20 million settlement with a coalition of U.S. states after accusations the company improperly marketed the blockbuster antipsychotic drug Abilify (aripiprazole). The pharmaceutical giant will pay $19.5 million to 42 states and the District of Columbia to resolve claims it engaged in unfair or deceptive trade practices when marketing Abilify. The company denied any wrongdoing. The settlement was announced December 8, 2016.  Court approval is pending. Abilify generated $5.5 billion in sales in 2014.

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A Texas jury has ordered pharmaceutical giant Johnson & Johnson to pay over $1 billion to six plaintiffs who said the implant maker hid flaws in its hip implants. A federal jury in Dallas on December 1 concluded that J&J’s DePuy Orthopaedics unit knew about the risk that its Pinnacle hip implants would fail but did not warn patients or doctors. According to plaintiffs, metal debris from the Pinnacle metal-on-metal hips entered the bloodstream and caused a number of complications that led to implant failure.

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The Judicial Panel for Multidistrict Litigation issued an order to consolidate dozens of Invokana (canagliflozin) diabetic ketoacidosis (DKA) and kidney damage lawsuits to New Jersey federal court, according to court documents filed Dec. 7. Effective immediately, the Panel transferred Invokana and Invokamet (canagliflozin and metformin) lawsuits from districts in Illinois, Kentucky, Missouri, Minnesota, Virginia and West Virginia to the District of New Jersey before U.S. District Judge Brian R. Martinotti. Invokana and Invokamet belong to a class of Type 2 diabetes drugs called SGLT2 inhibitors that work by stopping the kidneys from reabsorbing blood sugar.

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The U.S. Food and Drug Administration (FDA) has received reports of acute pancreatitis linked to SGLT2 inhibitor Type 2 diabetes medications, the agency announced on its website. The FDA said it was “evaluating the need for regulatory action” for acute pancreatitis in the SGLT2 inhibitor class of drugs. The statement was included in the Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) list from April to June 2016. “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA said on its website.

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