Recalls expanded on defibrillators, infusion pumps

Recalls, warnings

A recall of defibrillators, including Powerheart, CardioVive, Nihon Kohden and GE Responder models, because faulty components may cause the devices to fail to properly deliver a shock.

An order to recall and destroy all Colleague Volumetric Infusion Pumps was issued by the FDA to Baxter Healthcare Corp. after several class I recalls and changes to the pumps did not resolve problems resulting in adverse events.

A strengthened warning on naltrexone (Vivitrol) for extended-release injectable suspension regarding the risk of injection-site reactions. A new medication guide for patients lists risks and benefits.

A voluntary recall of certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier because the connector on the flex tube may not fit securely within the endotracheal tube (ET) connector, possibly resulting in the product becoming disconnected from the patient ET tube.

A class I recall of specific lots of the Aisys and Avance Anesthesia Systems because the control board wiring harnesses have a defect that can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

A voluntary recall of all lots of metronidazole, ondansetron and cipro-floxacin, manufactured by Claris Lifesciences, due to the discovery of non-sterility in lots of metronidazole injection produced on their shared manufacturing line.

Approvals

The Alair Bronchial Thermoplasty System, the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults. The approval was based on a 300-person trial showing a reduction of severe asthma attacks on a long-term basis, although there is a risk of immediate asthma attacks during the course of the treatment.

Sipuleucel-T (Provenge), autologous cellular immunotherapy approved to treat asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. A controlled trial found an increase in overall survival of 4.1 months in men taking the drug.

Trypanosoma cruzi, that causes Chagas disease. The assay is intended to detect antibodies to T. cruzi in serum or plasma specimens obtained from donors of whole blood and blood components.

Natazia, a new oral contraceptive that contains an estrogen (estradiol valerate) and a progestin (dienogest). It is the first four-phasic oral contraceptive marketed in the United States. The most common side effects include irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne.

Miscellaneous

The FDA revised its recommendations on rotavirus vaccines, rescinding an earlier recommendation that the Rotarix vaccine be avoided after DNA from porcine circovirus type 1 (PCV1) was found in it. According to the agency, it is now appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. The benefits of the vaccines outweigh the theoretical risk of PCV1, the FDA has concluded.

A new MedWatch Safety Information mobile text message program will provide timely new safety information on human drugs, medical devices, and related safety topics. To subscribe to the pilot, health care professionals or patients should text FDA to 87000. Subscribers can expect to receive approximately three to five text messages a week during the six-month pilot. Standard text messaging rates will apply.

A review by the FDA suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists for prostate cancer. Most of the studies reviewed reported small but statistically significant increased risks. The agency has not made any conclusions about GnRH agonists, but physicians should be aware of these potential safety issues and carefully weigh the benefits and risks when determining treatment choices. In addition, patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease.

A trial of eltrombopag (Promacta) was recently discontinued because the drug was associated with thrombosis of the portal venous system in patients being treated for thrombocytopenia due to chronic liver disease. The FDA notified physicians in order to remind them that the drug is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), not chronic liver disease. Treatment should be aimed at increasing the platelet count to a level that reduces the risk of bleeding rather than normal levels. Caution should be exercised when administering Promacta to patients who have known risk factors for thromboembolism or current hepatic disease.

The FDA's new “Bad Ad” program will educate health care professionals who prescribe medications about what constitutes appropriate prescription drug promotion and advertising and collect their input. Health care professionals are encouraged to report a potential violation in drug promotion by sending an e-mail or by calling 877-RX-DDMAC. Reports can be submitted anonymously; however, the FDA encourages clinicians to include contact information so that DDMAC officials can follow up, if necessary.