http://www.yourlawyer.com/topics/overview/anaphylactic_shock Sat, 21 Nov 2009 20:56:35 -0800 pixel-app en http://www.yourlawyer.com/articles/read/12668 Wed, 14 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12668
"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

• Ambien/Ambien CR (Sanofi Aventis)
• Butisol Sodium (Medpointe Pharm HLC)
• Carbrital (Parke-Davis)
• Dalmane (Valeant Pharm)
• Doral (Questcor Pharms)
• Halcion (Pharmacia & Upjohn)
• Lunesta (Sepracor)
• Placidyl (Abbott)
• Prosom (Abbott)
• Restoril (Tyco Healthcare)
• Rozerem (Takeda)
• Seconal (Lilly)
• Sonata (King Pharmaceuticals)

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Although most cases (71%) have occurred within 2 hours of omalizumab injection, some (13%) delayed-onset cases have been reported after 2 to more than 24 hours, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. The FDA notes that anaphylaxis can occur after any dose of omalizumab (including the first dose), even if past doses were well tolerated.

The warning was based on a review of 48 case reports submitted to the agency from June 2003 to December 2005 from an estimated 39,500 omalizumab-exposed patients. The review showed that the incidence of drug-related anaphylaxis was at least 0.1%.

Anaphylaxis occurred after the first dose of omalizumab in 40% of cases and after repeat administration in 56% of cases. Some patients experienced anaphylaxis after 2 years of chronic treatment.

Symptoms included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat/tongue, dyspnea, cough, chest tightness, cutaneous angioedema, and generalized pruritus. Some patients required oxygen and parenteral medications. Pulmonary involvement and hypertension/syncope were reported in 96% and 13% of cases, respectively; 15% of these patients required hospitalization.

Healthcare professionals are advised to provide direct medical supervision during omalizumab administration and to observe patients for at least 2 hours after each injection. Trained personnel should be able to recognize anaphylaxis and treat it appropriately with available medication and equipment.

The FDA advises discontinuation of omalizumab in patients who experience a severe hypersensitivity reaction; in the case reports, all 5 patients who were rechallenged with omalizumab after resolution of anaphylaxis experienced a recurrence of similar symptoms.

Patients receiving omalizumab therapy should be informed of the risk for anaphylaxis, the potential for delayed reactions, and advised to be on the lookout for symptoms such as wheezing, cough, chest tightness, or increased trouble with breathing; dizziness, fainting, rapid or weak heartbeat; swelling in the mouth and difficulty swallowing; flushing, itching, hives, or a sensation of warmth; and vomiting, diarrhea, or abdominal cramping.

In addition, patients should be advised to carry medical information and be fully prepared to begin treatment for anaphylaxis, including use of an epinephrine auto-injector and obtaining immediate medical attention for recognized symptoms.

Omalizumab is indicated for the treatment of moderate to severe persistent asthma in patients aged 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen whose symptoms are inadequately controlled with inhaled corticosteroids.
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Xolair was approved by the FDA in 2003 to treat patients with allergy-related asthma. It was previously believed that the risk of anaphylaxis was most severe within two hours of receiving the injection. However, the FDA decided to issue its latest warning after receiving reports that serious allergic reactions can develop up to 24 hours after being administered the drug, and even longer in some cases.

“Due to the nature of continued reports in the post-marketing experience, including their life-threatening potential, frequency, and the possibility for the delayed onset of anaphylaxis, FDA has now requested that Genentech, Inc., add the boxed warning and strengthen the existing warning,” the alert said.

“The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis.”

Symptoms of anaphylaxis include difficulty breathing, tightness in the chest, dizziness, fainting, itching and hives, and swelling of the mouth and throat. The FDA noted that they have received reports from approximately 39,500 patients who’ve been treated with Xolair and that “at least 0.1 percent” of those people suffered anaphylaxis following treatment, which would translate to about 40 instances of anaphylaxis among that cohort. In other words, about one of every thousand patients who take Xolair have had severe allergic reactions.

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A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives.

The risk of anaphylaxis was known when Xolair, also called omalizumab, was approved as an asthma treatment in 2003. But the Food and Drug Administration ordered the drug manufacturer, Genentech, Inc., to strengthen the label warnings because of reports of patients having a delayed reaction of anaphylaxis or reacting to a subsequent dose even when they had no problems after a first dose.

The new warning says:

• Doctors should observe patients for at least two hours after the drug is injected and be ready to manage a potentially life-threatening reaction.
• Anaphylaxis can occur even if a patient did not react to a previous Xolair injection.
• Anaphylaxis can occur up to 24 hours after the injection is given.
• Patients using Xolair should be prepared for to treat themselves for anaphylaxis in emergency situations.

]]> http://www.yourlawyer.com/articles/read/12577 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12577
Xolair was approved in 2003 to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen (pollen, grass or dust) and whose symptoms are inadequately controlled with inhaled steroids. In clinical trials, Xolair decreased the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of baseline inhaled corticosteroid dose.

Anaphylaxis was reported following administration of Xolair in clinical trials and was therefore, discussed in the initial product labeling. The cases were reported at a frequency of approximately one in a thousand patients (0.1%). Due to the nature of continued reports in the post-marketing experience, including their life-threatening potential, frequency, and the possibility for the delayed onset of anaphylaxis, FDA has now requested that Genentech, Inc., add the boxed warning and strengthen the existing warning. As the agency gains experience and collects data about a marketed product the determination may be made to strengthen the product label to ensure that consumers are aware of newly identified significant risks.

The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis.]]> http://www.yourlawyer.com/articles/read/12579 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12579
The FDA said the boxed warning should emphasize Xolair (omalizumab) might cause anaphylaxis, including trouble breathing, chest tightness, dizziness, fainting, itching and hives and swelling of the mouth and throat.

In addition, FDA ordered Genentech to revise the Xolair label and provide a medication guide for patients to strengthen the existing warning for anaphylaxis.

Xolair was approved in 2003 to treat adults and adolescents suffering moderate to severe persistent asthma and who have tested positive for a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled steroids.

Although anaphylaxis was reported in about one-in-1,000 patients during clinical trials, the FDA said continued reports prompted it to issue the Wednesday order.]]> http://www.yourlawyer.com/topics/overview/anaphylactic_shock Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/anaphylactic_shock Anaphylactic Shock Anaphylactic shock, also known as anaphylaxis arises when a person ingests or comes into contact with a substance to which they are severely allergic. Prescription medicines, food, insect stings and latex commonly cause anaphylactic shock. This reaction can be life threatening and individuals with asthma, eczema, or hay fever are at greater relative risk of experiencing anaphylaxis. This allergic reaction may affect the skin, respiratory tract, gastrointestinal tract, and cardiovascular system.

Anaphylaxis symptoms happen within minutes to two hours after contact with the allergy-causing substance. In rare cases symptoms can take place up to 4 hours later. According to statistics, 30 out of 100,000 persons experience anaphylactic reactions yearly. An up to date study illustrated that teens with food allergy and asthma appear to be at highest risk for a reaction because they are more likely to eat away from home. Therefore they are less likely to bring medications, and they may disregard or not recognize symptoms.

Symptoms of Anaphylactic shock

• Tingling sensation
• Itching
• Metallic taste in the mouth
• Hives
• Warm sensation
• Asthma
• Swelling of mouth & throat
• Difficulty breathing
• Vomiting
• Diarrhea
• Cramping
• Drop in blood pressure
• Loss of consciousness

If you or a loved one took a prescription medication and you went into Anaphylactic shock, please fill out the form at the right for a free case evaluation from one of our experienced defective drug attorneys.]]>