Zofran has been connected to a wide range of birth defects. Prescription drugs are often at the center of legal action. In many of these cases, it is uncovered that the drugs were not properly evaluated before they were marketed to physicians to prescribe to their patients. In other cases, drugs were prescribed outside of…Details
The U.K.’s Medicines and Healthcare products Regulatory Agency issued a statement urging surgeons to stop using a specific combination of Johnson & Johnson and Stryker metal hip devices due to unacceptably high rates of failure. The combination is Mitch TRH cup/heads and Accolade femoral stems.
The FDA has announced that it will hold an advisory panel on June 27-28 to gather input from scientists, researchers , patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements before a medical devide is sold in the U. S. This panel is in response to mounting…Details
The Gynecare Prolift was introduced in March 2005 by J&J, however the U.S. FDA did not learn about the Prolift until 2007 when J&J was seeking approval for a related product. There are currently more than 550 lawsuits against J&J alleging injuries caused by vaginal mesh implants.
A British review of larger diameter metal on metal hip implants found, “unequivocal evidence that metal-on-metal stemmed prostheses are associated with higher failure rates than other types, and that the use of large head sizes, and use of these prostheses in younger women, is associated with a particularly high rate of early revision surgery.”
The publication Consumer Reports has been long known for it’s reviews of products including automobiles and home appliances, but has now taken on medical devices. Consumer Reports President, Jim Guest wrote an email to 1 Million Americans earlier this year stating, “The implant that fixed your knee or your heart may actually be a ticking…Details
As the result of a packaging error, Pfizer has recalled 1M packets of birth control pills. A statement issued by Pfizer indicated that, “As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception and at risk for unintended pregnancy. The recall…Details
Newer isn’t always better. A new study links the drug metformin, prescribed for diabetes, to fewer cases of pancreatic cancer, at least in women, but finds other diabetes medications are associated with a higher risk of the disease. According to Dr. Peter Butler, a diabetes researcher at UCLA “the oldest drug we have for diabetes,…Details
The Journal of Pediatrics recently published a study showing thtat over the past decade increasing numbers of young children have been hospitalized or injured due to accidental poisoning from prescription and over-the-counter (OTC) medications. The majority of the cases involved unintentional self-ingestion for example where a child finds pills from an open container prescrived to…Details
The Food and Drug Administration has ordered medical device manufacturers to study safety complications with surgical mesh used in women’s pelvic surgeries. In April an FDA report found that women who have the surgical mesh implanted are at greater risk of pain , bleeding and infection than women who have traditional surgery with stitches. For…Details