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J&J’s DePuy Orthopaedics Unit Receives FDA Warning Letter

In a warning letter dated December 8th, federal health regulators warned Johnson & Johnson’s DePuy Orthopaedics unit that several of its hip, knee and joint replacements were improperly marketed. In response to the FDA’s warning, DePuy has decided to stop selling all if its custom fitted devices.

In its letter, the U.S. Food and Drug Administration outlined that several of DePuy’s custom devices and their corresponding components needed new PMA (premarket approval) or 510(k) applications. The FDA also noted that DePuy did not adequately notify regulators that it would be distributing approximately 14 of its products as custom devices.

The FDA backed its claims by stating that the devices DePuy distributed were far too similar to its standard products to be considered “custom” devices. The products in question include those made for the knee, ankle and hip.

According to a statement released by a DePuy spokesperson, the company now plans to address all quality issues cited in the FDA’s warning letter.

Adverse Events in Hospitals Often Go Unreported

According to a study released today by the Office of the Inspector General for the U.S. Department of Health and Human Services, approximately 86% of adverse events experienced by patients go unreported, never finding their way into the databases of incident reporting systems.

Hospital administrators interviewed for the purposes of the study said that the adverse events not captured by these special incident reporting systems were not believed to be reportable. Unreported incidents, which even included those resulting in the death of a patient, included mostly hospital-acquired infections, as well as four cases of excessive bleeding due to the administration of anticoagulants.

The OIG’s study goes on to recommend that the Centers for Medicare and Medicaid Services partner with the Agency for Healthcare Research and Quality in order to create a master list of the potentially reportable adverse events hospital staff and healthcare providers may encounter. This master list could be used to eliminate any questions, confusion or uncertainty with regard to whether or not an incident is worthy of being reported. Presently, the three main organizations that accredit hospitals do not have a standardized list of reportable patient adverse events.

(Source: Medscape.com)

Lawsuit Alleges Link Between Breast Cancer and DES

DES (diethylstilbesttrol) is a synthetic estrogen that was once prescribed to millions of women across the world in order to prevent miscarriages, premature births and other issues. The drug was manufactured, marketed and sold by pharmaceutical companies from 1938 until the early 1970′s. However, in 1971, the U.S. Food and Drug Administration ordered that doctors stop prescribing the drug for their pregnant patients, after a study revealed that the use of DES during pregnancy could increase the risk of developing a rare vaginal cancer.

Thousands of lawsuits have been filed since the 1970′s, claiming links between DES and cervical and vaginal cancer, most of which were settled before ever making it to trial. This month, a trial in Boston is believed to be one of the first major DES-related cases to allege a link between use of the drug and breast cancer in DES-daughters over the age of 40. The plaintiff, Arline MacCormack, was made aware of DES by her when she was only 17 years old. Thirty years later, MacCormack believes that the drug her mother took in order to prevent a miscarriage has caused her to develop breast cancer at the young age of 44.

MacCormack is among the more than 50 women across the country who are suing the makers of DES. Moreover, her lawsuit alleges that 14 drug makers, including Eli Lilly and Bristol-Myers Squibb, withheld FDA reports that showed information about the safety of DES from doctors.

Novartis Recalls Excedrin, NoDoz, Bufferin and Gas-X

The U.S. Food and Drug Administration confirmed that Novartis Consumer Health has recalled certain packages of Excedrin, NoDoz, Bufferin and Gas-X Prevention, over concerns that some of the bottles may contain stray pills of other medicines, as well as broken or chipped pills.

The Novartis recall affects Excedrin and NoDoz medicines with the expiration dates December 20, 2014 or earlier. It also includes Bufferin and Gas-X Prevention medicines with expiration dates of December 20, 2013 or earlier.

To date, federal regulators have not received any reports of adverse events stemming from the precautionary recall. Mixing different pills in the same bottle can be potentially dangerous, as consumers could inadvertently take the wrong product, which could cause consumers to suffer an overdose or an allergic reaction from injecting an unintended ingredient.

J&J Agrees to Pay $1 Billion to Settle Risperdal Probe

According to a recent reports from Bloomberg News, pharmaceutical company, Johnson & Johnson, has agreed to pay the U.S. more than $1 billion in order to settle the civil investigation into the company’s marketing practices of its popular antipsychotic, Risperdal.

J&J, one of the world’s largest makers and distributors of health products, reportedly reached an agreement with the U.S. Attorney in Philadelphia over the civil charges last week. However, talks of a criminal plea are still ongoing.

Federal prosecutors have been investigating J&J’s sales and marketing practices for Risperdal since 2004, including the allegations that J&J marketing Risperdal for unapproved uses.

(Source: Bloomberg News)

FDA Orders New Safety Studies for Surgical Mesh Implants

The U.S. Food and Drug Administration this week issued an order for new safety studies on surgical mesh implants, which are often implanted in women to repair weakened or damaged tissue and to provide support in cases of pelvic organ prolapse (POP). The surgical mesh can also be used to help women suffering stress urinary incontinence.

The FDA’s order for new studies came after the regulatory agency received more than 1,500 reports of complications related to the surgical mesh, including erosion and infection.

U.S. health regulators also announced they may reclassify the devices, listing them in a higher-risk category. A reclassification would mean that manufacturers of the devices, such as Johnson and Johnson, and Boston Scientific, would need to conduct clinical studies in people prior to receiving FDA approval.

In 2010 alone, approximately 75,000 women have received surgical mesh repairs for pelvic organ prolapse, and more than 200,000 received transvaginal repairs for stress urinary incontinence.

Surgical mesh has been used for decades as a means by which to repair abdominal hernias. However, physicians only began to use the mesh for POP procedures back in the 1990′s and doing so has since become quite popular.

(Source: Reuters.com)

Judge Orders Mediation for First Yaz Trial

The first Yaz trial, which involves a plaintiff who suffered a pulmonary embolism after taking the drospirenone-containing birth control pill, was set to begin on January 9th. However, the federal judge overseeing thousands of Yaz, Yasmin and Ocella venous thromboembolism lawsuits, instead ordered that all involved parties meet with a special mediator in order to negotiate a settlement for the litigation.

Judge Herndon’s December 31st order has delayed the start of a trial that was likely going to help both the prosecution and the defense gauge how juries would react and respond to the evidence presented in many of the cases. Stephen Saltzburg, a professor at the George Washington School of Law, was the Special Master appointed to mediated the entire litigation.

To date, more than 10,500 women have filed product liability lawsuits against Bayer AG, alleging that they suffered injuries as a result of Bayer’s failure to properly warn users of the potentially dangerous side effects of Yasmin, Yaz and other drospirenone-containing birth control pills.

According to a recent report by the U.S. Food and Drug Administration, birth control pills that contain drospirenone, a new kind of synthetic progestin, may increase the risk for blood clots by as much as 75 percent over older-generation birth control pills.

Tips for Preventing of Travel-Related Thrombosis

In today’s fast-paced society, many individuals opt for airline travel when they need to cover long distances in the shortest amount of time. That said, it is important to remember that prolonged air travel can cause passengers to develop a dangerous condition known as venous thromboembolism, or VTE. While the occurrence of VTE is rare for flights lasting less than six hours, the odds steadily increase as travel time increases. Moreover, the risk for VTE also increases with the presence of underlying conditions such as, a medical history of deep vein thrombosis, pregnancy, estrogen use, malignancy, advanced age, obesity, immobility, recent major surgery, congestive heart failure and other thrombophilic disorders.

Here are some general tips for all travelers to consider for the prevention of VTE:

1) Be sure to drink plenty of liquids. Stay hydrated.

2) Do not wear constrictive clothing, especially from the waist down, when traveling.

3) Take time to get up and walk around during the flight, at least every two hours.

4) Routinely flex and extend your feet and your knees while sitting in your seat.

FDA Warns Pharmacists of Mix-ups with Durezol and Durasal

The U.S. Food and Drug Administration is warning pharmacists about potential dispensing errors that could occur as a result of a mix-up between 2 drugs with very similar brand names. Patients given the wrong prescription due to pharmacist confusion and subsequent dispensing mistakes could endure serious injuries.

The two brands in question are Durezol and Durasal. Durezol, manufactured by Sirion Therapeutics, is an FDA approved topical corticosteriod indicated for relieving postoperative inflammation and pain. Durasal, made by Elorac Inc., is an unapproved, topical wort remover which contains salicylic acid.

On December 27, the FDA announced that the brand names caused such confusion that a pharmacist inadvertently dispensed Durasal to a patient recovering from eye surgery instead of the prescribed Durezol. As a result, the patient was seriously injured.

Federal health regulators try to prevent this problem by comparing the names of products going through the approval process to others currently on the market. Unfortunately, this precautionary check was not made for Durezol and Durasal, given the fact that Durasal did not go through the FDA’s approval process.

Label Check: Infant Acetaminophen

The recent introduction of a less-concentrated version of liquid acetaminophen for infants has prompted the U.S. Food and Drug Administration to suggest that parents and caregivers double-check the labels on all liquid acetaminophen products prior to administering any to their child.

While the newer, less-concentrated form of the pain reliever (160 milligram per 5 milliliter) has started to arrive on pharmacy shelves, many people may have the more concentrated, original version (80 milligram per 1 milliliter) at home in their medicine cabinet. According to a recent FDA report, the availability of differing concentrations has lead to many overdoses in infants, some of which have even resulted in the death of a child due to liver failure.

The FDA has asked parents to take care when administering liquid acetaminophen pain relievers to their children, suggesting that they read the “active ingredient” section of the Drug Facts label for products marketed to treat infants or children.

It is important to note that there are no dosing instructions for children under the age of two. Parents of children younger than two must consult a physician prior to administering any medication.

(Source: RedOrbit.com)

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