FDA approves generic Pravachol 80mg tablets

Teva Pharmaceutical Industries Ltd said U.S. health regulators granted final approval for its generic equivalent of Bristol-Myers Squibb Co’s cholesterol treatment Pravachol 80 mg tablets.

Teva said it was already marketing the 10 mg, 20 mg and 40 mg strengths of its Pravastatin Sodium tablets.

Pravastatin (Pravachol) Information

Pravachol is the brand name. Pravastatin is the generic name. Pravachol is the most studied statin (cholesterol-lowering drug) in clinical trials. It is used to decrease LDL cholesterol and triglyceride levels and increase the HDL cholesterol (the “good” cholesterol) level. Pravachol is also proven to reduce coronary heart disease events and deaths due to heart attack or stroke.
For more information on Statins and how they work, see Understanding Cholesterol-Lowering Medications, Medical Treatment.
Basic medication information is as follows:

  * Active ingredient: Pravastatin sodium
  * Dosage form: Tablet
  * Strength: 10, 20, 40, 80 mg
  * FDA approval: 10/31/1991
  * Company name: Bristol Myers Squibb

Why Is Pravachol Used?
Pravachol is a prescription medication that lowers the levels of “bad” cholesterol and triglycerides and raises the level of “good” cholesterol in the blood. LDL, or low-density lipoprotein, is referred to as the “bad” cholesterol. HDL, or high-density lipoprotein, is known as the “good” cholesterol. Pravachol is indicated for both adults and children older than 8 years whose cholesterol is not reduced enough with exercise and a low-fat diet.

Use of Pravachol in children is specifically indicated for an inherited condition, known as heterozygous familial hypercholesterolemia, that causes High cholesterol at a young age. Pravachol is indicated for children aged 8 years and older with heterozygous familial hypercholesterolemia (girls in this age range must have already begun menstruating). When used along with diet, Statins reduce total cholesterol, LDL, and apo B levels in children with heterozygous familial hypercholesterolemia. After an adequate trial of diet therapy, Statins may be considered for treatment in children if one of the following findings is present:

 
• LDL-C remains greater than or equal to 190 mg/dL.  
• LDL-C remains greater than or equal to 160 mg/dL and one of the following exists:
       
  • A positive family history of premature cardiovascular disease      
  • Two or more other cardiovascular disease risk factors in the pediatric patient

Pravachol Side Effects

Pravachol side effects and those of other cholesterol lowering medications (called Statins) have been the subject of much controversy in recent years. For this reason, many people are now looking for natural alternatives to Statins to avoid the possible Pravachol side effects.

What is Pravachol and how does it lower cholesterol?
Pravachol and other statin medications are prescription drugs that lower LDL (bad) cholesterol levels. Some of the other more popular ones are Lipitor, Zocor and Mevacor. Some doctors recommend statin drugs even for patients who don’t have High cholesterol as a precaution.

Pravachol and other statin drugs work by blocking the enzyme that your liver needs to produce cholesterol. Although Lipitor has limited effect on HDL (good) cholesterol, it does succeed in lowering your LDL cholesterol. However, Pravachol side effects can be very serious, and doctors should be more cautious when prescribing it for their patients.

What are the Pravachol side effects?
In addition to the side effects common to most prescription medications such as headaches, nausea and fever, other Pravachol side effects can be much more serious.

FACT: An FDA approved statin called Baycol was recently pulled off the market due to serious side effects and even deaths.

Two of the most troubling potential Pravachol statin effects include extreme muscle pain and muscle disease (statin induced myopathy), and serious liver problems.

According to an article in USA Today, a consumer watchdog group known as Public Citizen linked “72 fatal and 772 non-fatal cases of muscle breakdown (rhabdomyolysis) to all six of the Statins sold between October 1997 and December 2000.” Their research also revealed 29 earlier deaths.

Because of its effects on liver enzymes, Pravachol side effects may include liver problems. As such, anyone with liver disease or other liver issues probably should not take statin medications…Pravachol manufacturers warn against it.

Other potential Pravachol side effects:

In addition to serious muscle and liver problems much research has shown that Pravachol side effects could include sexual dysfunction and performance problems, as well as memory loss, personality changes and irritability.

Some additional concerns regarding prescription cholesterol lowering drugs:
1) While cholesterol lowering drugs do lower LDL (bad) cholesterol, they have limited effect on HDL (good) cholesterol, and no effect on triglycerides (fats), an equally important heart disease risk indicator.

2) Statin medications decrease your body’s supply of CoEnzyme Q10 (CoQ10), which is an essential nutrient for heart strength and function.

3) There are natural cholesterol lowering ingredients, some of which have been shown to outperform Statins in lowering cholesterol, without the possible side effects.