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Oakland Tribune - FDA investigating link between allergy drug, suicide

admin — Fri, 09 Jan 2009 06:26:02 +0000

WASHINGTON — The Food and Drug Administration said Thursday it is investigating a possible link between Merck’s best-selling Singulair and suicide.
The FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
With sales of $4.3 billion last year, Singulair is used by millions of patients in the U.S, according to Merck. First approved in 1998, it’s part of a class of asthma and allergy drugs that includes AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo.

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Merck officials stressed that the FDA’s inquiry is based on reports, not clinical studies — which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
“We have no indication that anything about the mechanism of Singulair is consistent with these events,” said George Philip, director of research and product development. “But because suicide is a life-threatening event, we thought it was important to provide this information in the product label.”
“Patients should not stop taking Singulair before talking to their doctor,” FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes.
FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a “causal relationship” between Merck’s drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received before October.
It could take up to nine months before agency scientists can draw any conclusions, the FDA said in a posting to its Web site.
The agency recently began notifying the public earlier about possible safety issues. The policy change came after the FDA was criticized for acting too slowly on information about the risks of Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes pill Avandia.
Merck has updated the drug’s labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
The company said it recently added reports of suicide to Singulair’s label, which already listed suicidal thinking and behavior as reported side effects.
In clinical trials of asthma patients, the most common side effects were headache, flu, abdominal pain and cough.
FDA said it is also reviewing reports of side effects with rival drugs, such as Accolate and Zyflo. Their labeling does not contain language about suicide.
Dr. Rauno Joks, an allergy specialist, said Thursday that Singulair is generally well tolerated by his patients.
“Some of them have headaches with it but nothing I could imagine developing into depression or suicide,” said Joks, head of the allergy division at State University of New York’s Downstate Medical Center.
Joks said he will continue prescribing the drug because there are few alternatives for asthma patients beyond inhalable steroids, the standard treatment for the disease.
Shares of Merck Inc. fell 1 cent Thursday to $44.77 in after- hours trading, following an earlier close at $44.78, up 8 cents for the day.
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written permission.
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Chain Drug Review - Risk dismissed

admin — Tue, 06 Jan 2009 11:56:02 +0000

No evidence exists that use of Singulair, an asthma/allergy drag, increases the risk of depression or suicide, according to data from three clinical trials. The trials, conducted by the American Lung Association, are highlighted in the Journal of Allergy and Clinical Immunology. The drug is also known by the genetic name of montelukast.

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Adverse Event Reporting News - FDA reviewing safety of Merck, Mylan drugs

admin — Mon, 05 Jan 2009 01:41:02 +0000

FDA March 27 announced it is investigating a possible link between suicidal behavior and the use of several popular asthma drugs, including Merck’s Singulair and Mylan Laboratories’ Zyflo.
Singulair is a medicine in the drug class known as leukotriene receptor antagonists, used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.
Over the past year, Merck has updated the prescribing information and patient information for Singulair to include several post-marketing adverse events: tremor, depression, suicidality and anxiousness.

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Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and to provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).
FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. The agency is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Other leukotriene modifying medications include Accolate (zafirlukast), which is also a leukotriene receptor antagonist, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took these drugs, as well, and will assess whether further investigation is warranted.
Due to the complexity of the analyses, FDA anticipates that it may take up to nine months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
FDA warned that patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, health care professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Asthma Treatment Using Singulair During Pregnancy

admin — Thu, 01 Jan 2009 17:36:03 +0000

If you are an asthma sufferer, then Singulair might be familiar to you. Singulair has been known as a safe medication for treating asthma. But a problem will occur when a woman who suffer from asthma gets pregnant. “What if I had asthma symptoms during my pregnancy? Is it safe to take Singulair during pregnancy?”
Singulair is a leucotriene (a chemical that cause inflammation during asthma and allergy) receptor blocker, which is functioning as an asthma symptoms reliever. Singulair has been known to have some mild side effects such as ear infections, headache or sore throat. However, the side effect of taking Singulair during pregnancy has been a subject of researches for sometimes. And until now, there are no possitive signs that taking Singulair during pregnancy could risk the pregnancy or the fetus.
“So, what must I do if I had asthma during my pregnancy if I cannot take Singulair?”….
First of all, Singulair is a prescription medicine to control and relief your asthma and allergy symptoms, it cannot be used as a rescue medication during asthma attack.
And secondly, as soon as you find out that you have had mild asthma symptoms like stuffy nose, sneezing, or mild bronchitis, you should take Singulair, even during pregnancy. Singulair will relief the symptoms, but it will also prevent you from getting more severe asthma attack. So, it is safer to have Singulair during pregnancy, than to have uncontrolled asthma during the pregnancy.
What you must remember is, that taking medication during pregnancy, even Singulair, is not recommended. Therefore, use it ONLY if it is necessary. You only need to take Singulair once a day, in the evening, as prescribed. If your asthma symptoms get worse, you can use inhaler for a fast relief. But the best and safest way to do is to always consult with your asthma doctor and your gynaekologist about using Singulair for pregnant woman for your asthma treatment.

HealthDay - FDA Probing Possible Link Between Asthma Drug and Suicide Risk

admin — Mon, 29 Dec 2008 16:41:02 +0000

The U.S. Food and Drug Administration said Thursday it was investigating the possibility of an increased risk of mood changes and suicidal behavior among those who take the highly popular asthma drug Singulair.
Singulair is the number one-selling drug among people aged 17 and younger. Last year, it posted sales of $4.3 billion, making it Merck & Co.’s top-selling product, according to the Associated Press .
In issuing its statement, the FDA stressed that asthma patients should not stop taking Singulair without talking to their doctor first.

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Both Merck and the FDA noted that the two have been working together over the past year to determine the scope of the problem and to make appropriate labeling changes to reflect the potential risk of mood changes and suicidal behavior among Singulair users.
“Suicide has been reported to us only in post-marketing experience in anecdotal reports that come …

Read the full article with a Free Trial at MyWire.

Internal Medicine News - Singulair: reports of suicidality under FDA review

admin — Tue, 23 Dec 2008 07:01:03 +0000

The Food and Drug Administration has issued an “early communication” to health care professionals regarding its review of the postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who have taken the asthma and allergy medication montelukast (Singulair).
At press time, the agency had declined to say how many reports of this kind it had received.
Dr. George Philip, senior director of clinical research at Merck & Co., which makes Singulair, also said the company would not reveal any more specific data at this time.
“We think that sharing those numbers is ultimately not very useful,” Dr. Philip said in an interview.

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An FDA spokeswoman said the agency had received reports of three or four suicides in patients taking Singulair. But no causal relationship has been established, she noted.
Merck agreed that reports did not necessarily signal a relationship. “The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the posmarketing event is caused by Singulair,” the company said in a statement.
The company picked up a signal of potential psychiatric adverse events throughanecdotal reports submitted to Merck over the last year or so as part of routine postmarketing surveillance, Dr. Philip said.
Merck updated Singular’s label in October 2007 to reflect a potential association with suicidality. In the past year, Merck has also added information that the leukotriene receptor antagonist has been associated with tremor, depression, and anxiousness.
FDA and Merck officials met in February to discuss how best to communicate the label changes to physicians, patients, and others, Dr. Philip said. Merck already had been–and will continue–communicating directly with physicians through face-to-face meetings.
An initial review of clinical trial data found no evidence of an association with mood changes, according to Dr. Philip. “In a cumulative analysis recently provided to the FDA of Merck’s randomized, double blind, place-bo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair,” the company’s statement said.
The FDA has asked Merck to review all its clinical data for evidence of suicidality or suicide. And the agency said it will review the postmarketing reports it has received on behavior and mood changes, suicidality, and suicide. The FDA said its investigation will take 9 months.
The American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology said in a statement: “There are no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports…. It is unknown whether there is an increased incidence of suicide in patients receiving Singulair.”
The two organizations recommended that patients taking Singulair tell their physician if any suicidal behavior or thoughts occur.
The FDA and Dr. Philip said that until the data review is completed, patients should not stop taking Singulair. The agency did urge physicians to monitor patients for signs of suicidality and other psychiatric events.
The FDA is also reviewing postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who took other leukotriene-modifying therapies, including zafirlukast (Accolate) and zileuton (Zyflo and Zyflo CR). It will then assess whether further investigation is warranted.
BY ALICIA AULT Associate Editor, Practice Trends
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Journal of Family Practice - Modest relief with montelukast for kids’ asthma attacks

admin — Wed, 17 Dec 2008 01:41:03 +0000

Robertson CF, Price D, Henry R, et al. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med 2007; 175: 323-329.
* Clinical question
Does montelukast reduce an asthma attack’s severity when given early in an acute attack to children with intermittent asthma?
* Bottom line
Yes. Montelukast (Singulair), when given at the first sign of an exacerbation or an upper respiratory infection, was slightly better than placebo in relieving symptoms and reducing health care use for children with intermittent asthma and 3 to 6 significant exacerbations per year. The children in this study were not taking controller medications.

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It’s not clear from this study whether montelukast is better than steroids, or if this approach is effective for children who are taking controller medications.
Level of evidence
2b: individual cohort study (including low-quality RCT)
Study design
Randomized controlled trial (double-blinded)
Funding
Industry
Allocation
Uncertain
Setting
Outpatient (any)
Synopsis
To be eligible for this study, children who were 2 to 14 years of age had to have:
(1) intermittent asthma with a history of at least 3, and no more than 6, episodes in the previous year that resulted in a hospital admission;
(2) an emergency department visit, plus 2 visits to a physician during asthma exacerbations; or
(3) 3 to 6 visits to a physician during asthma exacerbations.
Also, the eligible children could not be taking medications between attacks.
A total of 220 children were randomly assigned to receive montelukast or placebo administered by the parent or caregiver at the onset of asthma symptoms or at the first sign of an acute upper respiratory infection. Children between 2 and 5 years of age received 4 mg montelukast; older children received 5 mg daily. The children were treated for a minimum of 7 days, or until symptoms had resolved for 2 days. The maximum duration of treatment was 20 days. In addition to montelukast or placebo, the patients were also treated with a customized asthma management plan that included inhaled beta-agonists and oral prednisone.
During the follow-up period (approximately 10 months), 7 children had no acute episodes. The outcomes were evaluated using intention-to-treat analysis.
There were 345 acute episodes in the montelukast group and 336 in the placebo group. The children using montelukast sought health care 163 times, compared with 228 times for those using placebo. The symptom scores were slightly improved for the children taking montelukast. The episodes lasted, on average, approximately 1 week in each group. There was no difference in hospitalizations, the use of beta-agonists, or the use of prednisone.
FAST TRACK
Montelukast or placebo was given at the first sign of asthma exacerbation or upper respiratory infection
COPYRIGHT 2007 Dowden Health Media, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Tips to Improve Your Asthma

admin — Wed, 10 Dec 2008 06:46:02 +0000

1. Practice breathing from the diaphragm or abdomen instead of the chest. When you are breathing correctly the belly will push outward on breathing in, and contract or tighten when breathing out. The chest and shoulders do not rise up.
2. If you do start wheezing or getting short of breath try to breath slower while relaxing the rest of your body. This reduces the demand for oxygen in the body. If you are exercising slow down or stop.
3. Stop smoking or hanging out in smoky rooms whenever possible. If you live with a smoker who won’t quit or go outside to smoke then encourage the use of an air-filter or devise that sucks up the smoke. Don’t underestimate the dangers of second hand smoke, particularly on children and the elderly.
4. Try swimming as the exercise of choice. The increased moisture seems to lessen the chance of spasm of the bronchial tubes. Starting slowly with walking or a stationary bike can also safely improve cardiovascular stamina.
5. Drink extra glasses of water or liquids. With more rapid breathing it is easier to get dehydrated. Some regular tea is ok as it has a chemical to relax the bronchial tubes called Theo bromide, similar to the asthma medicine theophylline.
6. If you are using a rescue inhaler such as Albuterol more than three times a week you may need a preventive medicine either as another inhaler and/or a pill such as Singulair. Keep ahead of your asthma. At the first sign of worsening, use your medications early. In the end you will require less medicine overall. Make sure you tell your doctor if your symptoms become more frequent. In short, DON’T WAIT.
7. Often people with asthma also have allergies to pollen, animals, and dust. Discuss with your doctor getting allergy testing to see if desensitization shots will cure the problem. Be sure to mention stuffy nose and itchy, watery eyes “sinus problems” during your visit if they occur.

Medical Marketing and Media - Claritin the first of the big spenders

admin — Wed, 03 Dec 2008 07:41:03 +0000

Top 10 Pharmaceutical Product Web Sites Visited by Physicians
1. Pfizer’s Lipitor
2. Merck’s Fosamax
3. Shire’s Adderall XR
4. GlaxoSmithKline’s Advair
5. Bristol-Myers Squibb and Sanofi-Aventis’ Plavix
6. Johnson & Johnson’s Concerta
7. Merck’s Singulair
8. Forests Lexapro
9. AstraZeneca’s Crestor
10. Merck and ScheringPlough’s Zetia
Top 10 Pharmaceutical Product Web Sites Visited by US Adult Consumers
1. Sanofi-Aventis’ Allegra
2. Pfizer’s Zoloft
3. Pfizer’s Lipitor
4. GlaxoSmithKline’s Wellbutrin
5. SanofrAventis’ Ambien
6. GlaxoSmithKline’s Flonase

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7. Pfizer’s Celebrex
8. AstraZeneca Nexium
9. GlaxoSmithKline’s Paxil
10. Pfizer’s Zyrtec
Source: Manhattan Research
Lipitor’s Web site draws more physician eyeballs than any other drug site, followed by Fosamax and Adderall XR, according to a study by Manhattan Research, titled “ePharma Physician v6.0: The Future of Professional eMarketing.” Mark Bard, president of Manhattan Research, said, Top sites typically include those with a DTC component, as well as new products on the market. It is not just experience with a product that drives physician traffic to a specific site but the need for additional information.”-SM
Copyright Haymarket Media, Inc. Sep 2006
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Business Wire - Merck Announces Strong Financial Results for the Third Quarter 2006 Led by the Performance of SINGULAIR, VYTORIN and Vaccines

admin — Fri, 28 Nov 2008 11:06:04 +0000

* Company Posts Third-Quarter Earnings Per Share (EPS) of 51 Cents, Including the Impact of Reserving an Additional $598 Million Solely for Future VIOXX Legal Defense Costs and Excluding Restructuring Charges; Reported Third-Quarter EPS of 43 Cents
* VYTORIN and ZETIA Achieve Combined Global Sales of More Than $1 Billion in the Third Quarter
* Vaccine Sales Growth Strong; GARDASIL Reached $70 Million in the Third Quarter
* Merck Raises Full-Year 2006 Guidance and Now Anticipates EPS Range of $2.48 to $2.52, Excluding Restructuring Charges; Reported 2006 EPS Range of $2.18 to $2.25

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* U.S. Food and Drug Administration (FDA) Approved JANUVIA, the Company’s Once-Daily and First-in-Class Treatment for Type 2 Diabetes; and ZOLINZA, Merck’s Medicine for Advanced Cutaneous T-Cell Lymphoma (CTCL)
WHITEHOUSE STATION, N.J. — Merck & Co., Inc. today announced that EPS for the third quarter of 2006 were $0.51, including the impact of reserving an additional $598 million in the third quarter solely for future VIOXX legal defense costs and excluding a net $0.08 charge for site closures and position eliminations primarily associated with the global restructuring announced in November 2005. Reported EPS, including the impact of the net restructuring charge, were $0.43 for the third quarter of 2006 compared to $0.65 for the third quarter of 2005. Net income was $940.6 million, compared to $1,420.9 million in the third quarter of last year. Worldwide sales were $5.4 billion for the quarter, comparable to the third quarter of 2005.
Excluding the impact of the restructuring charges, EPS for the first nine months of 2006 were $2.02. Reported EPS were $1.81, including the impact of the $0.21 net restructuring charges taken during the year. Net income was $3,959.9 million and worldwide sales were $16.6 billion for the first nine months of 2006. Total sales increased 2% for the first nine months.
“The third quarter results reflect the recognition of the medical value of GARDASIL, our vaccine for cervical cancer. This week’s approval of our first-in-class diabetes drug, JANUVIA, marks the fifth product approval this year for Merck,” said Richard T. Clark, chief executive officer and president. “Given the results of the quarter, we remain on track to meet the goals we set for ourselves with our new business strategy.”
Materials and production costs increased 25% for the third quarter of 2006, including $199.6 million recorded in the third quarter for costs associated with the global restructuring program, primarily related to accelerated depreciation and asset impairment costs. Excluding these costs, materials and production increased 9% for the quarter. The gross margin was 71.5% which reflects a 3.7 percentage point unfavorable impact relating to the restructuring costs as noted above. For the first nine months of 2006, the gross margin was 73.9% which reflects a 3.4 percentage point unfavorable impact relating to restructuring costs.
Marketing and administrative expenses were $2,370.6 million, an increase of 43% in the third quarter of 2006. Included in marketing and administrative expenses is an additional $598 million reserve solely for future legal defense costs for VIOXX litigation recorded in the third quarter. Excluding this cost, marketing and administrative expenses increased 7% for the quarter. The results reflect the increase in the level of activity to support the three recently-approved vaccines and the imminent launch of JANUVIA in the United States.
Research and development expenses were $945.4 million for the quarter, comparable to the third quarter of 2005.
Restructuring costs were $49.6 million for the quarter, representing separation and other related costs associated with the Company’s restructuring program announced in November 2005. In the third quarter of 2006, the Company eliminated approximately 500 positions, bringing the total to approximately 3,900 since the inception of the program. Merck remains on track to eliminate 7,000 positions by the end of 2008.
Full-Year 2006 EPS Guidance
Merck anticipates full-year 2006 EPS of $2.48 to $2.52, excluding the restructuring charges related to site closures and position eliminations. Merck anticipates reported full-year 2006 EPS of $2.18 to $2.25. Please see pages 10 - 11 of this news release for details of Merck’s full-year 2006 financial guidance.
Third-Quarter Performance Highlights
Worldwide sales were strong for SINGULAIR, a once-a-day oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, reaching $868 million for the third quarter, representing growth of 25% over the third quarter of 2005. Sales for the first nine months were $2.6 billion, a 21% increase over the comparable 2005 period. SINGULAIR continues to be the number one prescribed product in the U.S. respiratory market.
Combined global sales of ZETIA and VYTORIN, as reported by the Merck/Schering-Plough partnership, exceeded $1.0 billion for the third quarter.