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The Food and Drug Administration is investigating the issue of counterfeit erectile dysfunction drugs.

A federal appeals court in Washington, DC, has decided that there is insufficient evidence to support a charge that the FDA improperly charged the manufacturer with marketing Viagra.

FDA spokeswoman Lisa Gill said the agency’s ruling was based on the fact that the FDA “did not comment on the specific charges raised in this litigation.”

The case was filed in October by men who were taking Viagra, Cialis and Levitra and whose prescription drugs contain the active ingredients known as sildenafil citrate, or “Viagra.”

The federal appeals court in Washington, DC, granted Pfizer’s motion to dismiss the complaint on the basis of insufficient evidence.

The Food and Drug Administration, the same FDA agency that the federal government is responsible for regulating, says that the agency should not be charged with ensuring that people can take their prescriptions in the correct dosage for the least possible risk.

The agency has not received any information about the counterfeit pills. The FDA said it would continue to monitor the situation and will address any questions about the FDA’s enforcement actions.

The case was brought by men who were taking Viagra, Cialis and Levitra and whose prescription drugs contained the active ingredients known as sildenafil citrate, or “Viagra.”

The FDA said that the company that supplied the drugs did not provide any information about the counterfeit pills, and that the company would continue to provide customers with the pills to which the products were coming, even if they had not been approved by the FDA.

In addition to the FDA’s ruling, the court in Washington has also said that it “has no evidence to support the allegations” that the FDA failed to adequately warn consumers about the risks of taking Viagra.

The case was originally assigned to the FDA’s Office of Criminal Investigations and is now assigned to the Office of Criminal Investigations, which is responsible for the investigation of illegal drug manufacturing.

Originally Published: September 26, 2010 at 4:00 AM EDT

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The FDA said it does not comment on the specific charges raised in this litigation. It is also not expected to provide any information about the counterfeit pills.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.CNET’s editorial cartoon

While the FDA may not have been aware of the counterfeit drugs that the agency has seized from consumers, it is still a possibility that the agency may not have taken appropriate action to warn consumers about the dangers of taking prescription drugs containing sildenafil.

This case was originally assigned to the FDA’s Office of Criminal Investigations. Its findings were later confirmed by the FDA. The agency is also investigating the case and is expected to make its final determination later this year.

This material may not be published, broadcast, rewritten, or redistributed.Copyright by The Associated Press.

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Interactions

A. Top Drug-Drug Interactions:

1.Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Cialis and nitrates both lower blood pressure. Taking them together can cause a significant and potentially life-threatening drop in blood pressure (hypotension), leading to dizziness, fainting, or even heart attack or stroke. It is contraindicated to use Cialis with nitrates or recreational "poppers" (amyl nitrites).

2.Alpha-blockers (e.g., prazosin, terazosin, tamsulosin): Both Cialis and alpha-blockers relax blood vessels, which can lead to excessive blood pressure reduction when used together. This may result in dizziness, fainting, or orthostatic hypotension (a sudden drop in blood pressure when standing). If needed, your doctor may adjust the dosage or recommend spacing the medications.

3.Other antihypertensive drugs (e.g., atenolol, propranolol, enalapril, lisinopril): Cialis can enhance the blood-pressure-lowering effects of these medications. While this interaction is usually less severe than with nitrates or alpha-blockers, it can still cause dizziness or fainting in sensitive individuals. Close monitoring of blood pressure is recommended.

Other Drug-Drug interactions:

  • Ketoconazole, itraconazole (used to manage fungal infection)
  • Protease inhibitors (used to manage HIV infection) Ex. ritonavir, lopinavir
  • Phenobarbital, phenytoin, carbamazepine (medicines used for fits)
  • Rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections)
  • Other medicines used to improve blood flow to the penis (Ex. sildenafil)

B. Drug-Food Interactions:

Cialis (tadalafil) can interact with certain foods and beverages, potentially altering its effectiveness or increasing the risk of side effects. Here are the key drug-food interactions to be aware of:

  1. Grapefruit and Grapefruit Juice: Grapefruit can increase the levels of tadalafil in your blood by interfering with its metabolism. This may amplify side effects, such as headaches, dizziness, or low blood pressure. Avoid consuming grapefruit or grapefruit juice while taking Cialis.
  2. Alcohol: Drinking alcohol with Cialis can enhance the blood pressure-lowering effects of the medication, leading to symptoms like dizziness, lightheadedness, or fainting. Limiting alcohol intake is recommended while using Cialis.
  3. High-Fat Meals: While Cialis can be taken with or without food, consuming it with a high-fat meal may delay its onset of action. Opt for lighter meals if rapid effectiveness is needed.
  4. Caffeine: Though not a direct interaction, combining Cialis with high caffeine intake might worsen side effects like headaches or increase heart rate in sensitive individuals.
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interactions

Other antihypertensive drugs (e.g., nitrates): Both Cialis (e.g., nitrates) and alpha-blockers reduce blood pressure by increasing blood flow to the penis, which helpsablished individuals develop sensitive responses to these medications. While this interaction is usually less severe than with nitrates or alpha-blockers:

  1. These medications can cause widening blood vessels, which can lead to a sudden decrease in blood flow when used together. If this response occurs, stop taking Cialis and just seek medical attention.
  2. Cialis can also alter the absorption or distribution of these medications, increasing their combined effects. Do not take Cialis with food or milk while taking alpha-blockers.
  3. Dr. Increase your dosage of Cialis with a doctor's help.

Cialis

Tadalafil, Tadalafil citrate. Is Cialis the generic name for this medication, its a generic name for tadalafil. Cialis is used to treat adult men with erectile dysfunction (ED), or.

How to Use Cialis

Take Cialis as directed by your doctor, usually on an empty stomach, with a glass of water. Follow your doctor's directions. Be sure to take Cialis exactly as directed. If you take Cialis with food or milk, you may take it with food or milk.

Side Effects of Cialis

Some side effects are serious. If you experience any of the following symptoms, stop taking Cialis and contact your doctor:

  • Stomach pain
  • Dizziness
  • Trouble breathing
  • Confusion
  • Swelling in the arms, hands, face, or feet
  • Lightheadedness
  • Unusual heartbeat
  • Dark urine
  • Pain, itching, or redness of the skin
  • Jaundice (yellowing of the skin or eyes)
  • High blood pressure
  • High cholesterol

Talk to your doctor or pharmacist before taking Cialis if you have any of the following medical conditions:

  • High or low blood pressure
  • Dental problems
  • Stomach problems
  • You may have an enlarged prostate
  • You may experience an infection in your mouth or throat
  • Hypercholesterolemia (high cholesterol)

How to Take Cialis

Cialis should be taken at a dose of 5 mg or 10 mg. If you take a dose more than once in a row, take the medicine only once.

Take Cialis exactly as directed. Follow your doctor's instructions. Do not take more or less of it or take it more often than prescribed by your doctor.

Warnings and Precautions

Before taking Cialis, tell your doctor if you:

  • Are pregnant, or think you might be pregnant, or you are taking any other medication. Cialis may cause fetal abnormalities. Ask your doctor about the risks and Precautions.
  • Have a history of blood clots. Tell your doctor about any prior history of stroke, heart attack, or blood clot, or if you are at risk of one.
  • Have diabetes. Your doctor will check your blood sugar levels to find the low level of Cialis that causes low blood sugar. If you are not sure, ask your doctor or pharmacist.
  • Have high blood pressure (high blood pressure in the blood vessels that supply your blood vessels), or have a condition that affects the blood flow of your heart or liver. Cialis may increase the risk of developing an. This medication is not approved for use in children under 18 years of age.
  • Have prostate problems, or have prostate cancer. Tell your doctor about your if you are having surgery to treat a prostate problem or if you need prostate cancer treatment. Cialis may increase the risk of having a stroke.
  • Have a condition that affects your eyes. When you are younger, your doctor may be more likely to see a different vision issue. Cialis may increase the risk of having a. This medication is not approved for use in women.
  • If you are having surgery to treat a prostate problem or if you are at risk of prostate cancer, you may be given a lower dose of tadalafil.
  • High blood pressure. Ask your doctor about Precautions if you are having surgery to treat a prostate problem or if you are at risk of having another surgery.

Precautions

This is not a complete list of risks and side effects associated with Cialis. Talk to your doctor before taking this medication if you are:

  • Taking other drugs that may cause drowsiness or dizziness;
  • Tell your doctor if you are taking any other medicines, including other medicines that can cause drowsiness or dizziness. Cialis may cause your blood pressure to drop.