US Pharm. 2007;32(3):102.

Xolair to Get Black Box Warning
The FDA requested that Genentech, Inc., manufacturer of the asthma drug Xolair (omalizumab), add a black box warning to the product following reports that it could cause anaphylaxis. Xolair is indicated for the treatment of asthma related to allergies.

Anaphylaxis is characterized by trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition to revising the label, the FDA also asked the company to provide a Patient Medication Guide to strengthen the existing warning for anaphylaxis.

Anaphylaxis surfaced in approximately one in a thousand patients (0.1%) during clinical trials and was therefore already mentioned as a possible adverse reaction in the product's labeling. A new boxed warning is necessary because of "continued reports in the post-marketing experience, including their life-threatening potential, frequency, and the possibility for a delayed onset of anaphylaxis."

Consumers Alerted to Dangers of Purchasing Drugs on the Internet
The FDA is warning consumers that the drugs they purchase over the Internet may not be what they think they are getting. The agency said that a preliminary analysis revealed that Ambien, Xanax, Lexapro, and Ativan tablets purchased over the Internet by consumers actually contained haloperidol, a powerful antipsychotic drug generally used to treat schizophrenia.

Reports show that several Americans have sought emergency medical treatment for symptoms such as difficulty breathing, muscle spasms, and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation. While the origin of the tablets is unknown, the packages were postmarked in Greece. The FDA is continuing to investigate this illicit trade on the Internet.

ADHD Drug Manufacturers to Notify Patients of Adverse Events
The FDA directed manufacturers of all drug products approved for the treatment of attention-deficit hyperactivity disorder (ADHD) to develop Patient Medication Guides to alert patients to possible adverse cardiovascular and psychiatric risks associated with the medicines and to advise them of precautions that can be taken.

An FDA review of reports uncovered serious cardiovascular adverse events in patients taking usual doses of ADHD medications. These adverse effects included sudden death in patients with underlying serious heart problems or defects and stroke and heart attack in adults with certain risk factors. Another review of reports uncovered a slight increased risk for ADHD drug–related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic. Psychiatric adverse events were reported even in patients who did not have a history of psychiatric problems.

Ketek to Get Revised Labeling
Ketek (telithromycin), an antibiotic manufactured by Sanofi Aventis, will be getting a new label and indication. The FDA reported that the changes include the removal of two of the three previously approved indications--acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. Ketek will remain on the market for the treatment of community-acquired pneumonia of mild to moderate severity.

The label will have a black box warning that Ketek is contraindicated in patients with myasthenia gravis. The company is also developing a Patient Medication Guide.

FDA Approves OTC Orlistat
The FDA gave approval for GlaxoSmithKline to begin marketing an OTC version of their diet drug, orlistat, under the brand name Alli. It is indicated in adults ages 18 years and older along with a reduced-calorie, low-fat diet and exercise program. The 60-mg capsule can be taken up to three days a day with each fat-containing meal.

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