Drug Recall Information Center

August brought changes to thirty-four (34) medical product labels, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

It took a New Jersey federal jury one hour and twenty minutes to determine that Fosamax did not cause a Plaintiff’s femur fracture.  In the first verdict in a Fosamax case where the Plaintiff claims that the osteoporosis drug weakened her thigh bone, the jury said that Plaintiff did not prove her case.

After having taken Fosamax for eight years, Plaintiff, now fifty-eight, fractured her right femur requiring surgical repair.  She sued alleging that Fosamax caused her atypical femur fracture, and that the manufacture, Merck, failed to warn her doctor about the risk.  Merck, pleased with the verdict, stated that the company provided appropriate and timely information about Fosamax to consumers.

Plaintiff’s suit had been transferred into the Fosamax femur fracture MDL, sometimes referred to as “Fosamax II” as an earlier Fosamax MDL was formed to deal with claims of osteonecrosis of the jaw (ONJ).  Merck has said that there are about 3,300 Fosamax femur fracture cases, and about 1,230 ONJ cases.

McNeil-PPC Inc. and Johnson & Johnson have asked that all New Jersey state court Tylenol liver injury cases be centralized before one Judge in the Middlesex County Superior Court, in order to avoid duplicative discovery, inconsistent rulings, and to conserve resources of the judiciary and the parties.  There are currently fourteen Tylenol cases pending in New Jersey state courts with Plaintiffs from twelve different states.

In their request that stated that since the federal Tylenol injury cases were centralized in April, thirty-three new federal cases have been transferred into the multidistrict litigation (MDL).

The defendants are refuting the plaintiffs’ claims that McNeil and Johnson & Johnson failed to warn about the risk of liver injury.  They claim that the risk has been known “for decades” and further claim that the FDA has repeatedly said that Tylenol and acetaminophen are safe when used as directed, and when recommended dosages are not exceeded.

June brought changes to forty-four (44) medical product labels (up slightly from 40 changes in May), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

The FDA has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards.  Other sites received regulatory warnings.

While the prices look good, you never really know what you’re getting.  These products can have too much or too little of the active ingredient that people need for the treatment of their disease, and some could have toxic ingredients.  Several of the sites had sleek interfaces and names that could easily be confused with legitimate pharmacies.  Walgreens-Store.com for example – the drugstore chain is actually Walgreens.com.

Though many of the sites present themselves as Canadian, most of them are based overseas – China, India, Pakistan, all around the world.  The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites and found that 97% did not fully comply with state and federal regulations. 88% didn’t require a valid prescription, and almost half of them sold medicines lacking FDA approval.

A Georgia federal jury ruled for the Defendant this week, determining that Mentor Worldwide LLC was not negligent in its design, manufacture, and sale of the ObTape pelvic mesh.

Also known as a vaginal sling, Plaintiff was implanted with the ObTape in December 2004 to treat bladder prolapse and urinary incontinence.  Six months later, she was diagnosed with vaginitis and a doctor found that the mesh had extruded into her vagina.

She filed suit claiming that the ObTape caused vaginal erosion and required surgical removal.  She further claimed that the pore size of the ObTape was insufficient to allow for tissue to become integrated into the device.  She said the mesh created a propensity for infection and/or abscess, resulting in an unreasonably high rate of infection, abscesses, tissue erosion and mesh extrusion.

May brought changes to forty (40) medical product labels (down from 48 changes in April), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected: