Firm Announcements

Pharmaceutical

TalkAboutIt.org, a website created by Heroes star Greg Grunberg in association with the Epilepsy Foundation to educate people about the seizure disorder, has launched a new campaign warning that medication switching can be dangerous especially to people who take medication for epilepsy.




Recalls

Hospira is recalling lots of injectible Liposyn and Propofol because some of the containers may contain particulate matter primarily made up of stainless steel. These contaminants, if injected into the blood stream, could lead to serious injury or death.




Pharmaceutical

Fifty-six patients from one health care clinic have died and 96 others were sent to the emergency room with overdoses after taking a powerful painkiller for a use not approved by the Food and Drug Administration (FDA). The drug in question is Cephalon's Actiq, a opioid approved by the FDA to treat breakthrough pain in cancer patients already being treated around-the-clock with opioids.




Recalls

A type of battery pack used to charge semi-automatic external defibrillators (AED), cardiac devices used to treat adults in a heart attack by automatically delivering an electric shock to the heart if needed to restore normal heart rhythm, are being recalled by the manufacturer because the battery packs may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy.




Recalls

Two lots of GammaGard Liquid, a treatment used to treat primary immunodeficiency disorders, are being pulled from the market as a precautionary measure because of an increased number of adverse event reports of allergic reactions associated with two lots of the product. A market withdrawal is defined in federal regulations as an action taken by a firm to remove or correct a distributed product because of a problem. The action is not considered a recall.




Environmental

The U.S. Occupational Safety and Health Administration (OSHA) has sent a letter to U.S. Coast Guard Admiral Thad Allen requesting his help in communicating the agency's "growing concern over significant deficiencies in BP's oil response operations related to worker safety." In the letter, David Michaels, the Assistant Secretary of Labor for Occupational Safety and Health, said that the oil giant's failures to adequately protect workers involved in the oil spill cleanup efforts pose "potentially grave consequences" for their health.




Pharmaceutical

A federal judge has ruled that makers of generic drugs are not protected from lawsuits even if the Food and Drug Administration (FDA) certifies them as the "bioequivalent" of their brand-name predecessors. U.S. District Judge Berle M. Schiller refused to dismiss a suit brought by consumers who were previously taking the brand name antidepressant Wellbutrin but claim they experienced side effects after switching to the generic version, buproprion. The lawsuit claims that Teva Pharmaceuticals and Impax Laboratories, both manufacturers of buproprion, knew of the reported side effects but failed to warn consumers of the differing release rates of the active ingredient in the generic drugs versus the brand name.




Recalls

Last January, an Associated Press investigative report found that many Chinese manufacturers were substituting the toxic metal cadmium for lead in children's jewelry and toys after the U.S. Consumer Products Safety Commission effectively banned the use of lead in surface coatings and other products. Today, the CPSC and McDonald's announced that the cadmium, used by some manufacturers because it possesses lead-like qualities, has turned up in millions of promotional Shrek drinking glasses.

 




Recalls

Two intravenous (IV) antibiotics used to treat a variety of infections and an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery are being recalled by the manufacturer because the products may be contaminated, according to a public health alert issued by the Food and Drug Administration (FDA).




Recalls

An alternative treatment for dehydration in pediatric patients is being recalled by the manufacturer because some lots of the product were found to be contaminated, the Food and Drug Administration (FDA) reports. Baxter International Inc., says it initiated the voluntary recall on all manufactured lots of HYLENEX recombinant (hyaluronidase human injection) as a precautionary measure after routine stabilization testing found particulate matter in some vials. The particulate matter consisted of small, flake-like particles identified as glass. About 3,500 vials are included in the recall.