Cough and Cold Medications in Children Less Than Two Years of Age (January 17, 2008)

FDA has reviewed information regarding the safety of over-the-counter cough and cold medicines in children under 2 years of age and recommends that these drugs not be used in children in this age group due to potentially life-threatening side effects.

OrthoEvra Contraceptive Transdermal Patch (January 19, 2008)

FDA modified prescribing information for OrthoEvra Contraceptive Transdermal Patch to include the results of a new study conducted by the Boston Collaborative Drug Surveillance Program showing that users of the birth control patch were at higher risk for developing serious blood clots than women using birth control pills. The patch was studied in women aged 15-44. FDA believes that OrthoEvra is a safe and effective method of contraception when used according to the labeling which recommends that women with other risk factors for serious blood clots use an alternative form of contraception.

Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia), and Simvastatin (Zocor) (January 25, 2008)

FDA has announced an ongoing data review for Vytorin, Zetia, and Zocor after Merck/Schering Plough Pharmaceuticals reported preliminary results from the ENHANCE trial comparing the effect of combination ezetimibe and high-dose simvastatin against simvastatin alone on the atherosclerotic process in patients with heterozygous familial hypercholesterolemi. Merck/Shering Plough stated that there was no significant difference between Vytorin or Zocor alone in the amount of atherosclerotic plaque in the innter walls of the carotid arteries. There was, however, a greater lowering of LDL-cholesterol with Vytorin compared to Zocor. After reviewing data from the ENHANCE study, the FDA will determine whether any further regultory action is warranted with regard to Zetia an Vytorin.

NuCel Labs Eye Drops and Eye/Ear Wash Products (January 31, 2008)

NuCel Labs has announced a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash Products after testing indicated the presence of bacteria and particulate matter in the products. These non-sterile eye drops pose an unacceptable risk of causing eye infections which, in rare cases, can lead to blindness. Consumers should discontinue the use of these products immediately.

Varenicline (Chantrix) (February 1, 2008)

FDA iannounced important revisions to the Warnings and Precautions sections of the prescribing information for Chantrix regarding serious neurological and psychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depression, suicidal ideation, and suicide. Patients should speak to their health care providers with concerns or questions.

Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) (February 8, 2008)

FDA issued an early communication about ongoing safety review of Botox products due to reports of systemic adverse reactions including respiratory compromise and death. These reported reactions are suggestive of botulism, which occurs when botulinum toxins spread in the body beyond the site where it was injected. The most serious cases that resulted in hospitalization and death occurred mostly in children treated for cerebral palsy-associated limb spasticity, which is not an approved use in the United States.

Chattem Icy Hot Heat Therapy Products (February 8, 2008)

Chattem, Inc. issued a voluntary nationwide recall of Icy Hot Heat Therapy products due to consumer reports of first, second, and third degree burns, as well as skin irritation. All lots and sizes of the following products were recalled: Ice Hot Therapy Air Activated Heat for Back, Ice Hot Therapy Air Activated Heat for Arm, Neck, and Leg, and Aspercreme Pain Relieving Cream. Consumers should stop using these products immediately.

Fentanyl transdermal system CII Patches (February 17, 2008)

Actavis Inc. has announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches, which may have a fold-over defect causing the patch to leak and exposie patients or caregivers to the Fentayl gel. Adverse events include respiratory depression and possible overdose.