Affymax will reduce its workforce by approximately 230 employees, or 75 percent, in response to a restructuring due to the ongoing investigation of deaths and hypersensitivity reactions related to its erythropoietin agent, Omontys, for the treatment of anemia due to chronic kidney disease. Cuts will include commercial and medical affairs field organizations as well as other officers and employees. Affymax will evaluate strategic alternatives, including the sale of the company, its assets, a corporate merger, or even bankruptcy proceedings.

Clinical Specialties Compounding Pharmacy of Augusta, Georgia is voluntarily recalling all lots of sterile products produced and distributed at its site. The recall is a result of the FDA’s concerns regarding sterility after five patients were diagnosed with serious eye infections, termed endophthalmitis, following use of Avastin repackaged into syringes by the compounder. Clinical Specialties repackages Avastin and other drugs into individual single-use syringes from manufactured vials labeled as sterile. The FDA is recommending health care providers to stop using all sterile products distributed by the compounding pharmacy and return them to the company. An endophthalamitis infection occurs inside the eyeball and is a serious complication that can lead to permanent loss of vision.

Sanofi-Aventis was sued by a group of investors accusing the company of misleading them about the status of regulatory approval for the anti-obesity drug rimonabant, marketed in Europe as Acomplia and in the United States as Zimulti. The certified class covers only investors in Sanofi’s American depository receipts, not its common stock, and the judge disallowed one of the two lead plaintiffs from serving as a class representative since they owned only Sanofi common stock, traded on Euronext. The judge made that decision based on a 2010 U.S. Supreme Court ruling that restricts lawsuits in U.S. courts involving companies traded on foreign exchanges. Sanofi argued that the claims did not meet the requirement for class actions because the lead plaintiffs’ asset managers closely followed financial markets and the financial press at the time the firm made the alleged misstatements, but the judge disagreed. In 2006, a U.S. Food and Drug Administration advisory committee, concerned about the possible link between the drug and suicidal thoughts, recommend that the agency not approve the drug. The suit alleges misstatements related to this were made by Sanofi executives in two earnings calls.

The French National Agency for Medicines and Health Products, ASNM, is under formal investigation for alleged involuntary manslaughter. French magistrates have widened their criminal probe of the French drugmaker Servier to include the safety agency itself. The investigation centers around Servier’s drug for diabetes, mediator. According to a 2010 study by the French national health-care insurer, mediator was linked to heart-valve malfunctioning and caused an estimated 500 deaths. ASNM says that as of late 2011, 727 reports of patients suffering from heart-valve problems have been documented. The drug was withdrawn from other countries several years before the 2009 withdrawal from the French market and was never sold in the U.S.

The FDA released yet another warning of serious tissue damage and death from incorrect use of the high-flow, high-suction vacuum on Stryker’s Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems. Although the product, sold without agency clearance, was recalled in October 2012, additional death and injury reports in the five months since then have prompted the FDA to issue the updated notice. Under the certificate of medical necessity issued by the FDA following the first deaths, Stryker is required to ensure that all health care facilities using the device are adequately trained and have implemented the pre-use checklist available on the FDA website. Stryker no longer manufacturers the Neptune 1 Silver but still maintains and supports the device to customers it granted a certificate of medical necessity until March 1, 2014. Production of the Neptune 2 Ultra is currently on hold.

Manufacturing delays at a Sanofi-Aventis plant have caused a new shortage of isoniazid for the treatment of tuberculosis. The drug, in pill form, is marketed by Sanofi as Rifamate and combines the antibiotic rifampin with isoniazid. The FDA Safety and Innovation Act of 2012 requires companies to provide a reason for the shortage but Sanofi has only indicated “other.”