A Message from the U.S. Fire Administrator about Home Smoke Alarms

On April 10, 2009, 7-11 store at P. Faura St., Ermita, Manila, sold to me an ensaymada baked food product which did not bear visible (to unaided eye) name and address of the entity which baked said product.

web site with useful information:
U.S. Fire Administration for Citizens
http://www.usfa.dhs.gov/citizens/index.shtm

About the U.S. Fire Administration (USFA)

As an entity of the Department of Homeland Security's Federal Emergency Management Agency, the mission of the USFA is to foster a solid foundation in prevention, preparedness, and response by providing national leadership to local fire and emergency services.




A Message from the U.S. Fire Administrator about Home Smoke Alarms
http://www.usfa.dhs.gov/about/chiefs-corner/082708.shtm

Posted on August 27, 2008 by Gregory B. Cade, U.S. Fire Administrator

USFA is aware that there is a growing controversy about which type of smoke alarm is most appropriate to protect Americans in their homes. In accordance
with our mission to reduce life and economic losses due to fire, we offer the following guidance regarding home smoke alarms.
USFA recommends that every residence and place where people sleep be equipped with either both ionization and photoelectric smoke alarms or dual sensor
smoke alarms.

The body of scientific knowledge about fire, smoke, and smoke detection has developed over many years and is extensive. The USFA has either fully or
partially funded a number of research efforts, including a recent study by the National Institute of Standards and Technology’s (NIST) Center for Fire
Research. Other contributors to this knowledge include the Consumer Product Safety Commission (CPSC), the National Fire Protection Association,
Underwriters Laboratories, the Home Fire Safety Council, the Residential Fire Safety Institute, the Home Fire Sprinkler Coalition, and distinguished
academics with expertise in smoke alarm and sensor technology. The body of research reflects the following:

* There are two types of smoke alarms in general use for residential smoke alarms: photoelectric and ionization. These types of smoke alarms sense the
presence of smoke differently.

* The type of smoke produced by a fire depends strongly on the type of fire. Flaming fires produce a different type of smoke than smoldering fires.
* Both types of smoke alarms will detect the smoke from either a smoldering fire or a flaming fire. It has been factually established and well known
for many years that:
o Ionization type smoke alarms tend to respond faster to the smoke produced by flaming fires than photoelectric type smoke alarms, and
o Photoelectric type smoke alarms tend to respond faster to the smoke produced by smoldering fires than ionization type smoke alarms.
* In some full-scale fire tests, the difference in the time to alarm between ionization and photoelectric type smoke alarms has been found to be trivial. In other full-scale fire tests, the difference in response time has been found to be considerable.

Based upon the above, the USFA provides the following guidance to the public and to state and local legislative bodies that may be grappling with the issue
of the proper type of smoke alarm to select for use in a residence:

* It cannot be stated categorically that one type of smoke alarm is better than any other type of smoke alarm in every fire situation that could
possibly arise in a residence.
* Because both ionization and photoelectric smoke alarms are better at detecting distinctly different yet potentially fatal fires, and because no one
can predict what type of fire might start in a home, the USFA recommends that every residence and place where people sleep be equipped with either
(a) both ionization and photoelectric smoke alarms, or (b) dual sensor smoke alarms (which contain both ionization and photoelectric smoke sensors).
* The location of a smoke alarm within a home may be more important than the type of smoke alarm present, depending on the location of a fire. The USFA
recommends that users follow the manufacturer’s guidance on the recommended location of smoke alarms in a home.

Additional information on smoke alarms can be found on the USFA, CPSC, and NIST Web sites.

Pacifiers Recalled by Healthtex Due to Choking Hazard
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09186.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
April 7, 2009
Release #09-186

Firm's Recall Hotline: (866) 348-5080
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Pacifiers Recalled by Healthtex Due to Choking Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Zoo Pacifiers

Units: About 40,000

Importer: Healthtex, of Miami, Fla.

Hazard: The pacifiers failed to meet federal safety standards. The nipples can separate from the base easily, posing a choking hazard to young children.

Incidents/Injuries: None reported.

Description: This recall involves Zoo pacifiers with animal cartoon figures as handles. The pacifier has a round-shaped mouth guard with three ventilation holes. “Made in Spain” is printed on the handle side of the mouth guard and “Mi Tosoro” is printed on the cardboard packaging.

Sold at: Supermarkets and pharmacy stores nationwide from December 2002 through March 2009 for about $1.40.

Manufactured in: Spain

Remedy: Consumers should immediately take the recalled pacifiers away from children and contact Healthtex for a refund or exchange.

Consumer Contact: For additional information, contact Healthtex toll-free at (866) 348-5080 between 9 a.m. and 5 p.m. ET Monday through Friday.


GE Recalls Ranges Due to Fire and Burn Hazards
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09189.html

NEWS from CPSC
U.S. Consumer Product Safety Commission


FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html
FDA News

FOR IMMEDIATE RELEASE
March 31, 2009


Media Inquiries:
Rita Chappelle, 301-796-4672,
Christopher Kelly, 301-796-4676
Consumer Inquiries:
888-INFO-FDA

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
Patients Still Have Access to Approved Narcotics for Pain Relief

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.

Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.

"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.

Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. These consumers should consult a health care professional for detailed guidance on treatment options.

"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."

Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.

To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at:
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics

Information on FDA-approved drugs: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Drugs Marketed in the United States That Do Not Have Required FDA Approval:
http://www.fda.gov/cder/drug/unapproved_drugs

If you would like to hear a replay of the FDA's telebriefing on this issue, callers in the United States and Canada may dial 1-888-566-0502. International callers may dial 1-203-369-3058. The replay will be available until April 6, 2009 at 11:59 p.m. EDT.

#


FDA Newsroom

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
April 8, 2009
Release #09-189

Firm's Recall Hotline: (888) 352-9764
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
GE Media Contact: (888) 240-2749

GE Recalls Ranges Due to Fire and Burn Hazards
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: GE Profile™ Freestanding Dual Fuel Ranges

Units: About 28,000

Manufacturer: GE Consumer & Industrial, of Louisville, Ky.

Hazard: The wiring in the rear of the range can overheat, posing a fire and burn hazard to consumers.

Incidents/Injuries: GE is aware of 47 reports of overheated wiring, including 33 reports of wiring that caught fire. Of these, one fire caused structural damage to the home and there have been 14 reports of minor property damage. No injuries have been reported.

Description: This recall involves GE Profile 30” Freestanding Duel Fuel ranges. The ranges were sold in white, black, bisque and stainless steel. The following model and serial numbers can be found on the left inside corner of the bottom drawer.
Brand Model Number Begins With: Serial Number Begins With:
GE Profile J2B900 LD, MD, RD, SD, TD, VD, ZD, AF, DF, FF, GF, HF, LF, MF
GE Profile J2B915 MF, RF, SF, TF, VF, ZF, AG, DG, FG, GG, HG, LG, MG, RG, SG, TG, VG, ZG

Sold at: Department and appliance stores nationwide from June 2002 through December 2005 for between $1,300 and $2,000.

Manufactured in: Mexico

Remedy: Consumers should immediately stop using the oven and contact GE for a free repair. Consumers can continue to use the cooktop burners.


http://google2.fda.gov/search?q=cache:RpVAB90TLiUJ:www.fda.gov/cder/warn/2006/Seroquel_letter.pdf+Seroquel&access=p&output=xml_no_dtd&ie=UTF-8&lr=&client=FDA&site=cder&proxystylesheet=FDA&oe=UTF-8
FDA re Seroquel

This is the cached copy of http://www.fda.gov/cder/warn/2006/Seroquel_letter.pdf.


Page 1
DEPARTMENT OF HEALTH & HUMAN SERVICES

TRANSMITTED BY FACSIMILE


This is the cached copy of http://www.fda.gov/cder/warn/2006/Seroquel_letter.pdf.
Page 1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
TRANSMITTED BY FACSIMILE
James L. Gaskill, PharmD
Director
Promotional Regulatory Affairs
AstraZeneca
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Mailstop D1C-715
Wilmington, DE 19803-8355
Fax (302) 886-2822
RE: NDA # 20-639
Seroquel
®
(quetiapine fumarate) Tablets
MACMIS ID # 14670
Dear Dr. Gaskill:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food
and Drug Administration (FDA) has reviewed a professional sales aid (238110) for Seroquel
®
(quetiapine fumarate) tablets (Seroquel) submitted by AstraZeneca under cover of Form FDA
2253. This piece is false or misleading because it minimizes the risk of hyperglycemia and
diabetes mellitus and fails to communicate important information regarding neuroleptic
malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution. Thus, the
promotional material misbrands the drug in violation of the Federal Food, Drug, and Cosmetic
Act (Act), 21 U.S.C. §§ 352(a) & 321(n). Cf. 21 CFR 202.1(e)(6)(i). The promotional material
raises significant public health and safety concerns through its minimization of the risks
associated with Seroquel.
Background
According to its FDA-approved product labeling (PI), Seroquel is indicated for the treatment of
acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct
therapy to lithium or divalproex and for the treatment of schizophrenia.
The PI includes important warnings and precautions. It states (in pertinent part):
WARNINGS
Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant
Syndrome (NMS) has been reported in association with administration of antipsychotic drugs,
including SEROQUEL. Rare cases of NMS have been reported with SEROQUEL. Clinical
Page 2
James L. Gaskill
AstraZeneca
Page 2
NDA 20-639
manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence
of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and
cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure.
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a
diagnosis, it is important to exclude cases where the clinical presentation includes both
serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or
inadequately treated extrapyramidal signs and symptoms (EPS). Other important
considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke,
drug fever, and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs
and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and
medical monitoring; and 3) treatment of any concomitant serious medical problems for which
specific treatments are available. There is no general agreement about specific
pharmacological treatment regimens for NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential
reintroduction of drug therapy should be carefully considered. The patient should be carefully
monitored since recurrences of NMS have been reported.
Tardive Dyskinesia
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in
patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears
to be highest among the elderly, especially elderly women, it is impossible to rely upon
prevalence estimates to predict, at the inception of antipsychotic treatment, which patients
are likely to develop the syndrome. Whether antipsychotic drug products differ in their
potential to cause tardive dyskinesia is unknown.
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are
believed to increase as the duration of treatment and the total cumulative dose of
antipsychotic drugs administered to the patient increase. However, the syndrome can
develop, although much less commonly, after relatively brief treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the
syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and
symptoms of the syndrome and thereby may possibly mask the underlying process. The
effect that symptomatic suppression has upon the long-term course of the syndrome is
unknown.
Given these considerations, SEROQUEL should be prescribed in a manner that is most likely
to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should
generally be reserved for patients who appear to suffer from a chronic illness that (1) is
known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but
potentially less harmful treatments are not available or appropriate. In patients who do
require chronic treatment, the smallest dose and the shortest duration of treatment producing
Page 3
James L. Gaskill
AstraZeneca
Page 3
NDA 20-639
a satisfactory clinical response should be sought. The need for continued treatment should
be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on SEROQUEL, drug
discontinuation should be considered. However, some patients may require treatment with
SEROQUEL despite the presence of the syndrome.
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar
coma or death, has been reported in patients treated with atypical antipsychotics, including
Seroquel. Assessment of the relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an increased background risk of diabetes
mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the
general population. Given these confounders, the relationship between atypical antipsychotic
use and hyperglycemia-related adverse events is not completely understood. However,
epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-
related adverse events in patients treated with the atypical antipsychotics. Precise risk
estimates for hyperglycemia-related adverse events in patients treated with atypical
antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical
antipsychotics should be monitored regularly for worsening of glucose control. Patients with
risk factors for diabetes mellitus (eg, obesity, family history of diabetes) who are starting
treatment with atypical antipsychotics should undergo fasting blood glucose testing at the
beginning of treatment and periodically during treatment. Any patient treated with atypical
antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia,
polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia
during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In
some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued;
however, some patients required continuation of anti-diabetic treatment despite
discontinuation of the suspect drug.
PRECAUTIONS
Orthostatic Hypotension
SEROQUEL may induce orthostatic hypotension associated with dizziness, tachycardia and,
in some patients, syncope, especially during the initial dose-titration period. SEROQUEL
should be used with particular caution in patients with known cardiovascular disease,
cerebrovascular disease or conditions which would predispose patients to hypotension.
Cataracts
Examination of the lens by methods adequate to detect cataract formation, such as slit
lamp exam or other appropriately sensitive methods, is recommended at initiation of
treatment or shortly thereafter, and at 6 month intervals during chronic treatment.
Seizures
As with other antipsychotics SEROQUEL should be used cautiously in patients with a history
of seizures or with conditions that potentially lower the seizure threshold.
Page 4
James L. Gaskill
AstraZeneca
Page 4
NDA 20-639
*
*
*
After reviewing the available data pertaining to the use of atypical antipsychotic medications
and diabetes mellitus adverse events, FDA asked all manufacturers of atypical antipsychotics
to include a warning in their PI regarding this risk on September 11, 2003. FDA believes that
the safe use of Seroquel can be enhanced by informing prescribers and patients about these
events and increased attention to the signs and symptoms of diabetes mellitus may lead to
earlier detection and appropriate treatment and thus reduce the risk for the most serious
outcomes. The PI including the hyperglycemia and diabetes mellitus warning for Seroquel
was approved on January 12, 2004.
Misleading Presentation
Page two of the professional sales aid starts with a prominent header, which states “Diabetes
Information,” and then presents the following five bullets:
• Hyperglycemia, in some cases extreme and associated with ketoacidosis,
hyperosmolar coma, or death, has been reported in patients treated with atypical
antipsychotics, including SEROQUEL
• The relationship of atypical use and glucose abnormalities is complicated by the
possibility of increased risk of diabetes in the schizophrenic population and the
increasing incidence of diabetes in the general population
• The results of retrospective studies of SEROQUEL and diabetes have been discrepant
• Postmarketing reports of diabetes or diabetes-related events are very rare (<0.01%)
with SEROQUEL. These reports were confounded by preexisting or coexisting risk
factors and/or had limited information
• SEROQUEL is an atypical that has had over 16 million patient exposures worldwide
since its approval in 1997. AstraZeneca believes that the available scientific and
medical data do not establish that SEROQUEL causes diabetes
The first two bullets contain information from the Warning in Seroquel's PI regarding
Hyperglycemia and Diabetes Mellitus concerning the observed hyperglycemic events and the
areas of uncertainty about the glucose abnormality findings. While the agency acknowledges
that it has not been established whether Seroquel causes diabetes, you fail to include
information regarding the increased risk of treatment-emergent hyperglycemia-related
adverse events in patients treated with atypical antipsychotics. The increased risk may be
due to confounding factors and is not completely understood, but a warning about it was
recently added to Seroquel's PI to enhance the safe use of Seroquel and protect public
health. Because your bullets about the relationship between the use of Seroquel and
hyperglycemia leave out this information, the bullets are misleading and undermine the
warning.
Furthermore, the fourth bullet claims that the percentage of diabetes or diabetes-related
events in post-marketing reports is "very rare (<0.01%) with Seroquel." In light of the
voluntary nature of post-marketing adverse event reporting by healthcare professionals and
patients, it is infeasible to obtain an accurate percentage of all diabetes or diabetes-related
Page 5
James L. Gaskill
AstraZeneca
Page 5
NDA 20-639
adverse events associated with Seroquel based upon these reports. Therefore, quantifying
post-marketing adverse events in this manner is misleading.
Omission of Material Facts
Promotional materials are misleading if they fail to reveal facts that are material in light of the
representations made or with respect to consequences that may result from the use of the
drug as recommended or suggested in the materials. Specifically, the professional sales aid
fails to include relevant risk information about the Warnings and Precautions that it presents.
While the professional sales aid states that “Prescribing should be consistent with the need to
minimize the risk of tardive dyskinesia,” it fails to reveal that the risk of developing the
condition and the likelihood that it will become irreversible are believed to increase as the
duration of treatment and the total cumulative dose of antipsychotic drugs administered
increase. The sales aid also fails to mention that the syndrome may partially or completely
remit if antipsychotic treatment is withdrawn. Additionally, the professional sales aid states
that “A rare condition referred to as neuroleptic malignant syndrome has been reported with
this class of medications, including SEROQUEL.” This statement is misleading in that it fails
to reveal that NMS is a potentially fatal symptom complex associated with the administration
of Seroquel. Furthermore, the professional sales aid fails to convey the important information
from the PI regarding the clinical manifestations of NMS and that management of NMS
should include immediate discontinuation of antipsychotic drugs.
The professional sales aid states that “Precautions include the risk of seizures, orthostatic
hypotension, and cataract development.” This statement is misleading because it omits
material facts from the PI about these risks. In particular, it fails to mention important
information from the bolded cataracts precaution recommending that physicians examine all
patients at initiation of Seroquel treatment or shortly thereafter, and at six month intervals
during chronic treatment, to detect cataract formation.
Conclusion and Requested Action
For the reasons discussed above, the professional sales aid misbrands Seroquel in violation
of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(a) & 321(n). Cf. 21
CFR 202.1(e)(6)(i).
DDMAC requests that AstraZeneca immediately cease the dissemination of violative
promotional materials for Seroquel such as those described above. Please submit a written
response to this letter on or before November 30, 2006, stating whether you intend to comply
with this request, listing all violative promotional materials for Seroquel the same as or similar
to those described above, and explaining your plan for discontinuing use of such materials.
Please direct your response to me at the Food and Drug Administration, Center for Drug
Evaluation and Research, Division of Drug Marketing, Advertising, and Communications,
5901-B Ammendale Road, Beltsville, MD 20705-1266, or facsimile at 301-796-9878. In all
future correspondence regarding this matter, please refer to MACMIS # 14670 in addition to
the NDA number. We remind you that only written communications are considered official. If
you choose to revise your promotional materials, DDMAC is willing to assist you with your
revised materials by commenting on your revisions before you use them in promotion.
Page 6
James L. Gaskill
AstraZeneca
Page 6
NDA 20-639
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is
your responsibility to ensure that your promotional materials for Seroquelcomply with each
applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action,
including seizure or injunction, without further notice.
Sincerely,
{See appended electronic signature page}
Robert Dean, MBA
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications
Page 7
---------------------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed electronically and
this page is the manifestation of the electronic signature.
---------------------------------------------------------------------------------------------------------------------
/s/
---------------------
Robert Dean
11/16/2006 08:56:28 AM


FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01992.html
FDA Statement

FOR IMMEDIATE RELEASE
Statement
April 8, 2009


Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

#

Additional Information
Efalizumab (marketed as Raptiva) Information

http://www.fda.gov/cder/drug/infopage/efalizumab/default.htm
Efalizumab (marketed as Raptiva) Information

FDA has been informed by Genentech, Inc., the sponsor of Raptiva (efalizumab), of their decision to initiate a voluntary withdrawal of Raptiva. The voluntary withdrawal will occur in phases over the next several months. Genentech’s decision to withdraw is based on the finding of an association with the use of Raptiva and an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Over the next several months, healthcare providers will be transitioning patients with psoriasis currently using Raptiva to alternate treatments. Healthcare providers are being asked to not initiate Raptiva treatment for any new patients.