The FDA's latest watch list includes over-the-counter (OTC) acne products containing benzoyl peroxide, salicylic acid, or both because of reported hypersensitivity and anaphylactic reactions.  Both agents treat acne by exfoliating dead skin cells that clog pores.  In addition, benzoyl peroxide kills bacteria and salicylic acid reduces inflammation.  Skin reactions and allergic reactions have been associated with both agents.  Being placed on the watch list does not mean the agents actually pose the reported health risks.  Rather, it means that the FDA will investigate whether there is a causal connection.  If the FDA does find a causal connection, the agency would consider a response such as gathering more information, amending the drug's label or requiring a risk evaluation and mitigation strategy.

The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs.  Patients who have questions should contact their health care provider.  FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.

[1] FDA Surveillance: "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2013", 1/27/2014.

Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have agreed to pay more than $2.2 billion to resolve criminal and civil allegations that the company marketed two powerful antipsychotic drugs, Risperdal and Invega, and one drug used to treat heart failure, Natrecor, for unapproved "off-label" uses.  All three of the drugs were aggressively marketed by the company to control erratic behavior in vulnerable patients including children, seniors, and the mentally disabled.   The settlement is the third largest settlement with a drug maker in U.S. history.  

In 1993, Risperdal was approved for treatment of schizoprenia, but J&J soon began promoting the drug for "off-label" uses that helped the drug become its #1 selling product by 2005 with sales over $3.5 billion.   In the plea agreement, Janssen admitted to promoting Risperdal as way to control behavior in seniors with dementia -- a use which is now explicitly prohibited on the drug's warning label because it can increase the risk of stroke and death in elderly patients.  

In 1999 FDA had warned Janssen that marketing to Risperdal as a safe and effective for the elderly would be "misleading," but over the years the company persisted in targeting nursing homes, nursing home pharmacists, and doctors who treated the elderly.  All the while, the company downplayed the drug's risks, including diabetes, weight gain, and risk of stroke.  Meanwhile the company also increased marketing of Risperdal to child psychiatrists as a treatment for common childhood disorders, such as attention deficit disorder and autism.  

The off-label uses of Risperdal, Invega, and Natrecor caused wasteful spending by federal and state health programs like the Department of Veterans' Affairs, Medicare, and Medicaid.  As part of the settlement, the company agreed to pay  $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits.

[1] Perrone, M. et al. "Johnson & Johnson To Pay $2.4 Billion To Resolve Drug Marketing Allegations," Huff Post (11/04/2013; 01/23/2014).

As DePuy Pinnacle's metal-on-metal hip design is being phased out, lawsuits continue to be filed claiming that the grinding of metal components in the implant sheds metallic debris into the patient's blood stream, causing swelling, pain, metallosis, and other complications that require surgery to correct.  Plaintiffs' attorneys argue that the DePuy Pinnacle model shares defective design qualities with the discontinued DePuy ASR hip implant.  In 2013, a $2.5 billion dollar settlement deal was reached to settle claims arising from the DePuy ASR hip implant.

[1] Emison, Brett A. "DePuy Just Can't Shake Those Hip Replacement Lawsuits", Law360 (Jan. 27, 2014).

[2] Meier, Barry "Johnson & Johnson in Deal to Settle Hip Implant Lawsuits", NY Times (Nov. 19, 2013).

Navilyst Medical, Inc. has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. The Recall is classified as a Class 2 recall.  The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port. The NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.  Affected Batch/Lot Numbers and instructions for returning the device are found here.

Earlier this month FDA approved Farxiga (dapaglifozin), a new tablet from Bristol-Meyers Squibb Co. and AstraZeneca Pharmaceuticals to help improve glycemic control in adults with type 2 diabetes.  Because an increased number of bladder cancers were diagnosed among Farxiga users in clinical trials, Farxiga is not recommended for patients with active bladder cancer. Side effects of Farxiga include genital mycotic (fungal) infections, urinary tract infections, and dehydration which can lead to a drop in blood pressure (hypotension), dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to these risks.  The FDA is requiring 6 post-market studies of Farxiga: 

• a  cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
• a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
• an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
• two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
• an enhanced pharmacovigilance program to monitor reports of  liver abnormalities and pregnancy outcomes.

 
[1] FDA News Release, "FDA approves Farxiga to treat type 2 diabetes" (Jan. 8, 2014).