• Boehringer Ingelheim withdraws Silomat

• FDA Launches Drug Safety Newsletter
 
• Revisions to Labels for Cialis, Levitra and Viagra

• Boehringer Ingelheim withdraws Silomat
German company, Boehringer Ingelheim has decided to voluntarily withdraw its clobutinol hydrochloride containing medications (Silomat) in all countries including Singapore where these medications are available. Patients are advised to discontinue its use.

Despite having been used since 1961 with 200 million patient-exposure, new findings from a clinical study in healthy subjects suggest that a potential risk of cardiac arrhythmia can not be excluded. This potential risk might be very low, but considering the indication and the availability of therapeutic alternatives, Boehringer Ingelheim has decided in the interest of patients´ safety to withdraw its Clobutinol containing products from the market as a precautionary measure.
 
Dr Andreas Barner, vice-chairman of the Board of Managing Directors and responsible for Research, Development and Medicine said, “We see our obligation to carefully consider any new information that becomes apparent and to initiate responsible measures to minimize and avoid even potential risks for patients. Therefore we decided to voluntarily recall clobutinol.”
 
The product is marketed by Boehringer Ingelheim under the brand name Silomat as an OTC medication in some countries, in other countries as a prescription-drug.

• FDA Launches Drug Safety Newsletter
 
In response to recent attention to drug safety issues, the US FDA has launched the first issue of the Drug Safety Newsletter, a quarterly publication designed to raise awareness about reported adverse events and stimulate more reporting. An adverse event report is a communication to FDA of an undesirable sign or symptom associated with a drug.

Who is the newsletter for?
Physicians, physician assistants, nurses, pharmacists, dentists, other allied health care professionals, health professional associations, and drug information centers.

What does it cover?
Findings of selected post-marketing drug safety reviews
Data from reports submitted to FDA's Adverse Event Reporting System
Information on new and emerging drug safety issues
Listings of recent public health advisories and information sheets
What's in the first issue (Fall 2007)?
Reports of a rare condition called progressive multifocal leukoencephalopathy associated with the use of Rituxan (rituximab), a medication to treat people with non-Hodgkins lymphoma and rheumatoid arthritis
Reports of serious skin reactions associated with Provigil (modafinil), a medication to treat excessive sleepiness caused by certain sleep disorders
Reports of aplastic anemia associated with Temodar (temozolomide), a drug used to treat certain types of brain cancer
An overview of adverse events associated with Exjade (deferasirox), an oral chelating agent used to treat iron overload due to multiple blood transfusions
Recent drug safety advisories posted in FDA's Web site
How is the newsletter distributed?
On the Web: FDA's Drug Safety newsletter is available on FDA's Web site at http://www.fda.gov/cder/dsn/default.htm
Through E-lists: People who subscribe to the Drug Safety Newsletter E-list (https://list.nih.gov/cgi-bin/wa?SUBED1=fda-dsn&A=1) or the MedWatch E-list (www.fda.gov/medwatch/elist.htm) will receive an e-mail message whenever a new issue is available online.

• FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
Potential risk of sudden hearing loss with ED drugs to be displayed more prominently
The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.

A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.

For more information:
http://www.fda.gov/cder/drug/infopage/ed?drugs/QA.htm

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