Sunday | September 02, 2007

Want some Viagra

Men between the ages of 30 and 65 will be required to see a pharmacist, provide a medical history and have their blood pressure, cholesterol and glucose levels tested. “It’s still very much a prescription drug,” Boots spokeswoman Clare Stafford said. “This is just a different access point to it.” If customers want a refill, they will be required to see a doctor, Stafford said. It's estimated that only one in 10 men suffering from erectile dysfunction are currently being treated.

Posted by tooz at 10:33:38 | Permanent Link | Comments (0) |

Wednesday | August 08, 2007

Drug firm accused of illegally promoting recreational use of impotence pill

A major U.S. AIDS treatment group plans to file a lawsuit Monday that accuses drug giant Pfizer Inc. of illegally promoting recreational use of its blockbuster impotence pill Viagra.

The AIDS Healthcare Foundation (AHF) told Reuters it wants Pfizer to be barred from marketing Viagra as a lifestyle or sexual enhancement drug. The nonprofit organization said Pfizer’s actions had led to risky behavior by men and an increase in HIV and other sexually transmitted diseases.

“Pfizer has created and contributed to the perception of Viagra as a safe, sexy, lifestyle, recreational drug, to be frequently used regardless of the degree, or even existence of” erectile dysfunction, the group said in draft legal documents.

Pfizer, the world’s largest drug maker, said it was committed to appropriate Viagra use and urged men to see a doctor for a proper diagnosis. The drug is sold by prescription.

AHF, in its legal arguments, pointed to several Viagra promotions from recent years, including a 2005 newspaper ad that featured a smiling man asking, “What are you doing on New Year’s Eve?”

Another ad that ran near the 2006 Super Bowl urged men to “Be this Sunday’s MVP” and ask their doctors about Viagra.

Posted by tooz at 11:51:21 | Permanent Link | Comments (0) |

Wednesday | August 01, 2007

Wyeth Affirms the Safety and Efficacy of Efexor and Efexor XL

Wyeth Pharmaceuticals affirms the safety and efficacy of EFFEXOR (venlafaxine HCl) and EFFEXOR XL? (venlafaxine HCl sustained release), (collectively EFEXOR), and disagrees with the United Kingdom's (UK) Medicine and Healthcare Products Regulatory Agency's (MHRA) decision to require interim measures that would restrict access to these treatments.

"Wyeth's most recent review of preclinical and clinical data, and 10 years of post-marketing experience with more than 10 million patients, confirm the safety and efficacy of EFFEXOR for the treatment of depression and anxiety," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer for Wyeth Pharmaceuticals. "Importantly, these data do not establish a relationship between therapeutic doses of EFEXOR and cardiac arrhythmias (disruptions of the heart rhythm) beyond what is currently described in our labeling."

The MHRA has required provisional labeling for EFEXOR in the UK that will state that: initiation of treatment should be restricted to specialist care with starting doses limited to 75mg; the products are indicated for moderate to severe patients; a baseline ECG is recommended for new patients; and, the products are contraindicated in patients with preexisting cardiovascular disease. Additional information regarding the MHRA's action is available on its Internet web site at www.mhra.gov.uk.

The MHRA's provisional action stems from, among other factors, its view that EFEXOR could be associated with disruption of the heart rhythm, and could be associated with severe reactions following abrupt discontinuation. Additionally, the Agency reviewed publications relying on data from the Office of National Statistics (ONS). The ONS data suggest that EFEXOR is associated with a rate of fatal overdose significantly higher than selective serotonin reuptake inhibitors (SSRIs), but significantly lower than the rate associated with tricyclic antidepressants (TCAs).

Wyeth's analyses of the ONS report using the UK's General Practice Research Database (GPRD) found that physicians prescribed EFEXOR to patients who on average had more risk factors for suicide than patients who were prescribed certain SSRIs. This is not unexpected since in clinical practice EFEXOR is frequently used when other agents (SSRIs, TCAs) have been ineffective. Specifically, prior to receiving EFEXOR, these patients had a higher incidence of prior hospitalizations for depression, schizophrenia along with depression, failure to respond to other antidepressants, and suicidal behavior in the preceding year. The magnitude of these risk factors is strikingly similar to the different rates of fatal overdose that were seen.

Moreover, in data from clinical trials in which there were controls to assure that patients were similar, EFEXOR was superior to placebo in reducing suicidal thoughts and performed at least as well as comparator SSRIs. Thus it appears most likely that the increased rate of fatal overdose observed with EFEXOR actually reflects a differential risk of suicide attempt inherent to the patients' conditions rather than a direct effect of EFEXOR itself.

Allison Jeynes-Ellis, M.D., Wyeth Medical Director, United Kingdom and Republic of Ireland, adds, "The MHRA's conclusions fail to account for these critical data. Restricting access to medication is not in the best interest of patients, and is a backward step in the treatment of depression in this country. In the UK, many of the nearly 300,000 EFEXOR patients have failed on one or more other antidepressants. The MHRA's action may lead to the increased use of less appropriate medications such as TCAs that have a long history of safety concerns - including a higher risk of fatal overdose, suicide, and disruptions of cardiac rhythm at therapeutic doses."

The MHRA has asked for new class labeling addressing suicide risk, dosing and discontinuation. Wyeth finds these changes consistent with the Company's recent labeling proposals made in the UK and is evaluating the appropriateness of these changes in other parts of the world.

While the MHRA has reaffirmed EFEXOR as an "important drug in treating many patients with depressive illness," Wyeth finds that the provisional labeling required by the MHRA will needlessly place restrictions on the future use of EFEXOR by inappropriately defining broad cardiovascular contraindications and by limiting initiation of EFEXOR therapy to specialist care.

Wyeth will challenge the MHRA's action and has urged the agency to accept the Company's previous recommendations for enhanced labeling, educational initiatives, and new packaging aimed to help physicians and patients reduce the risk of suicide and overdose. During the process, Wyeth will comply with the MHRA interim measures in accordance with regulation 6A of the Medicines for Human Use Regulations 1994. In addition, the Company intends to communicate with regulatory bodies worldwide regarding this information.
Posted by tooz at 07:33:31 | Permanent Link | Comments (0) |

Tuesday | July 31, 2007

Macrolides for pneumonia

Examples

azithromycin Zithromax clarithromycin Biaxin Biaxin XL erythromycin Eryc EryPed Ery-Tab

How It Works

Macrolides prevent bacteria from reproducing.

Why It Is Used

Doctors often use macrolides to treat pneumonia in otherwise healthy people younger than 60. For these people, macrolides are effective against the most common causes of bacterial infections in the lower respiratory tract.

Macrolides may be given to people who are allergic to penicillin.

Doctors use macrolides in people older than 60 and those with other long-lasting (chronic) health problems if the doctor suspects an uncommon cause of the pneumonia.

How Well It Works

In general, all antibiotics used have a high cure rate for pneumonia. For people in the hospital, cure rates are 73% to 96%; outside of the hospital, cure rates are generally above 90%.

Macrolides are effective against a wide range of bacteria.

You usually have some improvement in symptoms 2 to 3 days after treatment begins. Unless you get worse during that time, treatment is not changed for at least 3 days. You usually continue antibiotics for 7 to 14 days. Treatment may be longer for people with impaired immune systems or who have Legionnaires' disease.

Side Effects

The most common side effects of macrolides include:

  • Diarrhea.
  • Nausea.
  • Upset stomach.
  • Vomiting.
  • Sore mouth.

A recent large study indicates that people who take erythromycin along with certain common medications may increase their risk of sudden cardiac death. The study showed that the risk of sudden cardiac death is greater when erythromycin is taken with some medications that inhibit certain liver enzymes-such as certain calcium channel blockers, certain antifungal medications, and some antidepressants-than when these medications are not taken together.

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

Posted by tooz at 02:58:50 | Permanent Link | Comments (0) |

Diabetes Drugs: Old and New

Most type 2 diabetes drugs are equally effective for lowering blood sugar, but the generic drug metformin has fewer side effects than several newer, pricier medications, a government report finds.

Metformin users are less likely to gain weight than type 2 diabetes patients who take Avandia, Actos, or other newer medications, researchers concluded, and they are more likely to show improvements in so-called "bad" cholesterol.

The report was issued by the Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and Human Services.

Researchers from Johns Hopkins University’s Evidence-based Practices Center reviewed 216 previously published studies in their effort to compare the effectiveness, risks, and costs of older and newer diabetes pills.

The study, which was made public today, will appear in the Sept. 18 issue of the Annals of Internal Medicine.

Diabetes Drugs: Old and New

All diabetes medications help to lower blood sugar, but they work in different ways. Metformin and drugs in the class known as sulfonylureas, such as Glipizide or Glyburide, are among the least-expensive oral diabetes medications because generic versions are now available.

The newer oral medications Avandia (by GlaxoSmithKline) and Actos (by Takeda Pharmaceuticals) -- both in the drug class thiazolidinedione (TDZ) -- are now among the most widely prescribed diabetes drugs.

Among the highlights of the report:

  • Metformin was one of the few diabetes drugs not associated with an increase in weight. The report noted that other widely prescribed diabetes drugs have been shown to increase body weight by an average of 2 to 11 pounds.
  • Use of metformin was associated with a decrease in blood levels of low-density lipoprotein, or "bad" cholesterol, while use of the TDZ class of drugs raised levels good cholesterol and had a harmful effect on LDL "bad" cholesterol.
  • Amaryl, Glucotrol, and other sulfonylurea drugs were more likely to cause unsafe drops in blood sugar (hypoglycemia) than other diabetes drugs.
  • Patients on metformin or the drug acarbose complained of diarrhea and other gastrointestinal problems more than users of other drugs. Patients who took only metformin were more likely to experience these digestive problems than patients who took lower doses of metformin in combination with other diabetes drugs.
  • Use of Avandia and Actos was associated with a greater risk of congestive heart failure.
Posted by tooz at 02:55:55 | Permanent Link | Comments (0) |

Saturday | July 28, 2007

Treatment Of Seasonal Allergy Symptoms

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.

"Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects," says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. "However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children."
Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.

Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.

Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.
Posted by tooz at 05:59:43 | Permanent Link | Comments (0) |

About Zyrtec

Zyrtec (cetirizine HCl) is a prescription antihistamine for the treatment of seasonal and perennial allergies as well as continuing hives in adults and children.
It can be used in adults and children down to two years old, and for some of these allergies, it can even be used in infants as young as six months. In infants, 6 to 23 months old, side effects were like those of a sugar pill and included being cranky, fussy, and not able to sleep.
Other side effects were feeling tired and looking uncomfortable. In studies with children aged 2 to 11 years old, side effects included drowsiness, headache, sore throat, and stomachache. Most were mild or moderate.
Most children weren't bothered by side effects enough to stop taking Zyrtec. In studies with adults and children 12 years and older, the most common side effect was drowsiness; others included dry mouth and tiredness. Most were mild to moderate, but most people weren't bothered enough to stop taking Zyrtec.
About Pfizer Inc and UCB Pharma
Pfizer Inc is a research-based global pharmaceutical company that discovers, develops, manufactures, and markets innovative medicines for humans and animals.
UCB Pharma is a global, research-based pharmaceutical company dedicated to the development and commercialization of innovative pharmaceutical products for the treatment of diseases associated with the central nervous system and allergy-immunology. The company's research activities aim to promote well-being and quality of life. UCB Pharma, with US headquarters in Smyrna, Georgia, is a member of the UCB Group of Companies, which has core businesses in pharmaceuticals and chemicals. UCB employs approximately 10,000 people and operates in more than 100 countries. Worldwide headquarters are located in Brussels, Belgium.
Posted by tooz at 05:56:16 | Permanent Link | Comments (0) |

Thursday | July 26, 2007

The coauthor of a study that links the diabetes drug Avandia to an increased risk of heart attack and death says patients need to stay calm and talk to their doctors.

More than 6 million people around the world have taken the drug Avandia (rosiglitazone) to treat Type II diabetes. But a new study published this week in The New England Journal of Medicine suggests that the drug is linked to a higher risk of heart attack and death. In the study, Dr. Steven Nissen and Kathy Wolski of the Cleveland Clinic analyzed the results of 42 existing trials and found that Avandia increased heart-attack risk 43 percent. In response to the study, the Food and Drug Administration (FDA) issued a safety alert advising patients to talk to their doctors about whether they should continue taking the medication. Three major medical groups—the American Heart Association, the American College of Cardiology and the American Diabetes Association—also issued a joint advisory urging patients to call their doctors. "We don't feel this is an emergency or a crisis," says Dr. Sue Kirkman, vice president, clinical affairs, at the American Diabetes Association. Although it has been known for some time that drugs in the same class as Avandia increase the chances of developing congestive heart failure, the heart-attack risk is news, Kirkman says. However, she cautions, further analysis is needed to determine the severity of the risk. In a statement, Avandia's manufacturer, GlaxoSmithKline, defended Avandia’s safety, claiming that the study is based on "incomplete evidence." Nissen spoke to NEWSWEEK's Barbara Kantrowitz about his research.
Posted by tooz at 22:20:14 | Permanent Link | Comments (0) |

Let’s say you spend $500 a year

Do the math. Let’s say you spend $500 a year on covered drugs. Should you buy a Part D plan? Even with a low-premium plan, by the time you pay for the standard deductible and co-pays, you’ll have spent almost $700. So why spend the extra $200? “The key reason is protection against catastrophic costs,” says Curt Fey, a financial planner in Pittsford, N.Y. You’ll also avoid the procrastinator’s penalty. So people with low or zero drug costs might consider a barebones option.

The serious comparison shopping begins for people with costs at around $750. Medicare has posted the plans in each area, along with pricing and formularies (see www.medicare.gov.) NEWSWEEK asked Families USA, a health policy nonprofit, to test the annual cost of insurance plus co-pays for an imaginary resident of Chicago (costs vary by region) who takes five of the most popular prescriptions among seniors: 10 mg of Lipitor, 70 mg of Fosamax, 75 mg of Plavix, 100 mg of Zoloft and 200 mg of Celebrex. The results revealed a hefty difference in costs. Among 42 plans, the priciest, Cignature Rx, would cost the consumer $5,017, compared to the cheapest, $2,538 at Humana PDP.

Posted by tooz at 12:27:39 | Permanent Link | Comments (0) |

Nexium

Sales of the top five drugs, including Nexium, rose 12 per cent to $3.8bn in aggregate. Nexium contributed sales of $1.31bn to that.

Operating profits fell 7 per cent in the second quarter to $1.97bn, but were up 1 per cent to $4.14bn in the first half. Pre-tax profits were down 10 per cent to $1.99bn in the quarter, and flat at $4.25bn for the half year.

Earnings per share fell 7 per cent to $0.95 in the quarter, but would have been up 17 per cent to $1.19 excluding the MedImmune and restructuring costs. For the half year earnings per share rose 3 per cent to $1.97 or by 17 per cent to $2.25 on the adjusted basis.

The group declared a 6 per cent increase in the dividend to $0.52.

AstraZeneca said it expected to resolve its issues with the US Food and Drug Administration over its FluMist flu vaccine before the flu season began. In May the group received a Warning Letter from the FDA concerning compliance issues at the company's UK-1 manufacturing plant.

Posted by tooz at 11:42:38 | Permanent Link | Comments (0) |