FDA gets involved as some hip replacements prove unsafe

By | Product Liability

Residents of Tennessee and others across the U.S .needing a hip replacement procedure in the coming months may want to consider alternatives to metal-on-metal devices. Recent scrutiny of this potentially unsafe product means that people may want to opt for metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal devices. In recent months, many patients have experienced negative reactions from metal-on-metal hip implants. The Food and Drug Administration recently reviewed more than 100 studies of the metal-on-metal versions, determining they may cause problems for women and patients who received larger-sized hip implants. In an effort to protect patients from the effects of a defective…

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Actos Manufacturer May Have Covered Up Diabetes Drug Side Effects

By | Dangerous & Defective Drugs

A medical reviewer from Takeda Pharmaceutical Company, manufacturer of diabetes drug Actos, is blowing the whistle on her former employer, claiming that it covered up known cases of congestive heart failure related to Actos use. Specifically, she alleges that the company did not consider “non-hospitalized or non-fatal” cases of congestive heart failure between 2007 and 2010 as “serious” and report the side effects to the FDA. The U.S. Food and Drug Administration (FDA) regulates the production of dangerous drugs and requires negative side effects be self-reported to the agency via its Adverse Event Reporting System. The whistleblower claims that Takeda’s…

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Avandia To Be Removed from Tennessee Retail Pharmacies

By | Dangerous & Defective Drugs

Recognizing the heart risks Avandia poses to those who use it, the Food and Drug Administration announced new rules in May to pull the diabetes drug from the shelves of retail pharmacies throughout Tennessee and the rest of the U.S. Although the new rules don’t go into effect until November, many pharmacies have already stopped dispensing the controversial drug. Linked to severe cardiovascular events, including heart attack, congestive heart failure, stroke and liver problems, the FDA has determined that in the majority of cases, the risks of Avandia far outweigh its benefits for those living with Type 2 diabetes. The FDA’s…

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