Monday, October 1, 2007

Eli Lilly & Co.'s impotence drug Cialis features a middle-aged couple walking hand-in-hand past a restaurant while smooth jazz plays in the background. Toward the ad's end, a male voice lists common side effects, including headache, back pain and muscle aches.

"If advertisers were really interested in getting information about drug risks out, they'd show pictures of those problems, but you almost never see that," said Dr. Sidney Wolfe of the advocacy group Public Citizen, which frequently criticizes drug industry marketing.

According to the authors of the NEJM article, the FDA sent 21 citations to drug companies last year for problems with consumer-directed ads, compared with 142 in 1997.

During the same period, drug industry spending on such advertising soared 330 percent, to $29.9 billion in 2005 from $11.4 billion in 1996.

The U.S. is one of two industrialized countries that permit TV drug ads — the other is New Zealand.

The FDA's Tuesday announcement says a study is needed on whether some ads "simply distract consumers from carefully considering and encoding risk information."

Besides looking at how images used in ads affect consumers, the FDA will also study how text on the screen can focus or divert attention from audio warnings. FDA says text directing viewers to company Web sites or magazine advertisements can distract viewers from more important audio about side effects. On the other hand, FDA said the repetition of language about risks in text format could help reinforce warnings.

In response to increased scrutiny, the Pharmaceutical Research and Manufacturers of America recently issued voluntary guidelines for members on promoting drugs to patients. Members include Pfizer Inc., Merck & Co. Inc., Wyeth and most other major pharmaceutical companies.

The guidelines recommend companies submit TV ads to the FDA for review before broadcast. Drug companies agreed to start paying the agency $80,000 per ad to offset the cost of hiring more drug ad reviewers.

Last month, however, House lawmakers rejected the proposal, recommending that federal money finance the regulatory reviews. The legislators said having drug companies pay salaries of FDA ad reviewers could create potential conflicts of interest.

House lawmakers are slated to meet with their Senate counterparts in September to work out differences between companion bills aimed at increasing the FDA's enforcement powers.


Sunday, September 16, 2007

Cialis ® is a prescription medication for the treatment of erectile dysfunction. The active ingredient in Cialis is Tadalafil. Cialis is manufactured by Lilly ICOS.
Cialis is commonly sold in 10 mg and 20 mg strengths. For most patients, 10 mg is sufficient to achieve effective results. Doctor's usually start their patients on 10 mg and increase the dose if required. If 10 mg is sufficient for you, it may be more economical to purchase the 20 mg strength pills and split each pill into 2 pieces of equal size with a pill cutter (subject to the approval f your doctor). Taking more Cialis than is prescribed is unlikely to provide additional benefits and may in fact be harmful.
Cialis may produce some side effects. The side effects are generally mild and usually only last for a few hours. Side effects include headache and muscle pain. More information on Cialis side effects can be found here.
Cialis InformationCialis is a new impotence treatment and alternatice to Viagra. By expanding blood vessels and increasing blood flow to the region, Cialis delivers results in as little as 30 minutes (30 minutes sooner than Viagra).
Side EffectsCialis (Tadalafil )may produce some side effects. These side effects are generally mild to moderate in nature, and usually only last for a few hours. They include headache, dyspepsia, dizziness, flushing nasal congestion, back pain, and or muscle aches.
Cialis FAQs
1. How exactly does cialis work? Cialis works by enhancing the effects of one of the chemicals the body normally releases during arousal. This allows an increase of blood flow. An erection is the result of an increase in blood flow into certain internal areas. 4. How do I take this medication? Cialis should be taken before sexual activity. Cialis may be taken with or without food. For more detailed information consult with your health care provider. 5. Are there any side effects with Cialis? As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with Cialis during the testing of the product were: a. Headacheb. Indigestionc. Back Paind. Muscle Paine. Flushingf. Stuffy Nose
Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking Cialis and these usually go away by themselves within 48 hours. A small number of patients taking Cialis also reported abnormal vision. 6. What important information should you know about Cialis?: * CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication (alpha blockers are medicines used to treat benign prostatic hyperplasia and high blood pressure) other than FLOMAX (tamsulosin) 0.4 mg daily. You could get dizzy, faint or have a heart attack or stroke. * Tell your healthcare provider that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your health care provider to know when you last took Cialis. * After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.
7. What Should I Tell my Doctor? Your doctors should talk to you about your heart’s general condition and if Cialis is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with Cialis, Cialis is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours. 8. Is Cialis safe for everyone? No. Patients taking nitrates or alpha blockers should not take cialis and consult their doctor The combination of these with Cialis could significantly lower blood pressure and lead to fainting or even death in some men. Your doctor is the best person to determine if this medication is safe for you. 9. Can Cialis be used with other treatments for impotence? The safety and effectiveness of Cialis when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with Cialis is not recommended.
Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter) that way, you can receive the best advice for your own situation. Cialis is not recommended for people taking any form of nitroglycerin and most alpha-blockers, other than FLOMAX, because the combination may lower blood pressure to an unsafe level. 11. How is Cialis supplied? Cialis is available as oral tablets in 5mg, 10mg and 20mg strengths.