Generic Lipitor Hits the Market - Is it the Same Medicine?

Pfizer’s cholesterol-lowering Lipitor now faces competition from generic versions of the drug for the first time since it’s U.S. patent expired Wednesday. The pharmaceutical company’s blockbuster hit the market in 1997 and generated sales of $10.7 billion last year alone. Rivalry comes from India’s largest drug manufacturer, Ranbaxy Laboratories Ltd. The new generic drug will be labeled “atorvastatin calcium,” which is the chemical name of Lipitor.


Is there a clinical difference between Lipitor and its generics? Director of Consumer Reports Health Ratings Center John Santa says that there will not be a meaningful difference. In order to gain FDA approval, generics must contain the same active ingredients and be as safe and effective.


However, a good number of patients have experienced difficulties when a generic equivalent was introduced. According to the FDA, drug approval is based on three factors:

1. Pharmaceutical Equivalency – Does the generic contain the same chemically active ingredients and are they identical is dosage form and strength?These criteria may be affected by many things such as: 
• Variations in inactive ingredients
• Manufacturing facilities in different parts of the world
• In oral drugs, capsule content is allowed to vary 7% over or 7% under the stated content, resulting in a possible 14% variation.
• Age of the patient
2. Bioavailibility – Based on the amount of drug absorbed and the speed of absorption. Some generics may be absorbed faster or slower than the brand name drug.
3. Bioequivalence – Are the generic and the brand-name drug functionally equivalent? In order to approve any generic drug, the FDA requires that the generic be effective within a 20% range of the original patented drug. This means that it could be 20% more effective OR 20% less effective than its brand-name counterpart. For prescriptions such as anti-depressants or hormone-based medications, which require precise dosages, this could be the difference as to whether the generic is effective or ineffective for you.

Another risk associated with generic drugs is that a patient could receive a different generic each time they fill their prescription. Also, the difference in inactive ingredients found in generics may react differently with medications you are already taking.

So what should you do if you have the choice between a brand-name and a generic?

• Talk to your doctor. Ask if the generic counterpart is known to be as effective and if there are side effects. Be sure your doctor know all of your current medications and dosages. 
• Listen to your own body. Have you noticed any changes after switching to a generic? How do you feel? Are you experiencing any adverse reactions? These can all be red flags as to whether that generic is the best choice for you.

By far, generic drugs are not bad things, and often they save us a lot of money, but they are not always as good as the “original.”

Drug Maker Issues Correction After False Advertising

Following a meeting and warning of the FDA advisory panel, the makers of certain bisphosphonates have begun an ad campaign to correct their FALSE ADVERTISING. Genentech/Roche Group has started running an ad (which you may have seen in the Parade magazine included in your local newspaper) that begins with the following:

"AN IMPORTANT CORRECTION FROM BONIVA FOR WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS
You may have seen an ad about BONIVA for the treatment and prevention of postmenopausal osteoporosis that may have given you the wrong impression. Our ads stated that ‘After one year on BONIVA, 9 out of 10 women stopped and reversed their bone loss.’ The FDA has found that there is not enough evidence to support this statement and wants us to clear up any misunderstanding you may have had about these ads and make sure you have the correct information about BONIVA.”
And here's the part where they finally tell the truth that they had been hiding: "BONIVA has not been proven to stop and reverse bone loss in 9 out of 10 women and is not a cure for postmenopausal osteoporosis.”

It is unfortunate that pharmaceutical companies are able to propogate these sorts of half-truths and lies to the public to try to sell more of their product than their competitors. It is even more unfortunate that the product they are pushing has actually been causing harm to many women. There have been numerous reports of thigh bone fractures and necrosis (decaying) of major joints like hips and jaw bones. For more information on the problems and injuries caused by BONIVA and other bisphosphonates, please see our earlier post entitled Building Bones or Breaking Bones?.

If you would like for us to email you a copy of the ad, along with a copy of the updated medication guide, please feel free to contact us directly.

The lawyers at the Studstill Firm are interested in speaking with individuals who may have taken medications that have caused them to have injuries. While the idea of being involved in a lawsuit may not be appealing to many individuals, a consultation with us about your options is free and confidential. Please feel free to contact one of our products liability injury lawyers in Georgia by calling (478) 745-9002 (in Macon, Georgia) or (229) 686-3500 (in Nashville or Tifton, Georgia) or (229) 244-2908 (in Valdosta, Georgia) to set up an appointment or to discuss your potential case with someone over the phone.

Understanding Sunscreen Labels: FDA Helps Reduce Confusion and Permanent Injury

The U.S. Food and Drug Administration (FDA) announced Tuesday that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.

The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

Here's the key: Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

In addition to the final rule for sunscreen labeling, the FDA also released a Proposed Rule that would limit the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

The new regulations will become effective for most manufacturers in one year.

Cholesterol-Lowering Drug Warning

The Food and Drug Administration warned Wednesday that a popular cholesterol-lowering drug should no longer be prescribed at its highest dosage to new patients because of concerns that it can cause muscle damage.

The drug is simvastatin and the unsafe dosage level is 80 milligrams. This dosage level can increase the risk for myopathy, which is a form of muscle damage.

Simvastatin is sold under the brand name Zocor, in addition to being sold as a generic product. It is also sold in combination with other drugs under the brand names Vytorin and Simcor.

The FDA recommendation is that doctors only continue prescribing the 80 mg dose to patients who have been taking it for at least a year without experiencing problems.

Additionally, simvastatin should not be taken with some other drugs, including some antibiotics, HIV drugs and anti-fungal medications, according to the FDA and Merck, which makes the drug.

In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin at that dose, the agency said. About 12 percent of simvastatin users take that dose, according to Merck.

Teething Baby? Think Twice About Oral Medications

The FDA recently issued a warning concerning the use of Benzocaine, a local anesthetic used to relieve pain in the mouth and gums. The product is commonly used for pain associated with teething, canker sores, and irritation of the mouth and gums.

The FDA became concerned about products containing benzocaine because they may cause a rare but serious and possibly fatal condition where oxygen in the blood stream is greatly reduced. This condition is called methemoglobinemia. In the most serious cases, this condition can result in death.

Benzocaine products do not currently carry any warnings regarding methemoglobinemia, therefore, the FDA is concerned that consumers might not be aware of the danger or know what to look for when using these products. Signs and symptoms of methemoglobinemia include pale, gray or blue colored skin, lips and nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness, and rapid heart rate.

The FDA is particularly concerned about the use of benzocaine products in children under two years of age. There have been 21 reported cases of methemoglobinemia after using benzocaine gels and liquids. Eleven of the 21 cases occurred in children under age two.

If while using benzocaine products any of the symptoms of methemoglobinemia appear, persons should stop using the product immediately and call 911. If left untreated, serious cases may lead to permanent injury to the brain and body tissues, and even death. Parents are cautioned not to use this product on children less than two years of age unless it is given under the advice and supervision of a healthcare professional. These products should always be kept out of reach of children.

The American Academy of Pediatrics recommends that for teething problems in children, safer alternatives such as chilled teething rings or gentle massage to the gums using a cloth or your finger are preferred over benzocaine products. For a list of products containing benzocaine, visit the FDA’s website.

Recalled Hip Implants

After complaints from several hundred patients and a warning letter from the FDA, Johnson & Johnson is recalling its popular metal-on-metal hip replacement mechanism known as the ASR XL Acetabular System. This product is made by DePuy Orthopaedics which is a division of Johnson & Johnson.

This product is being recalled due to its high failure rate which results in additional hip replacement surgeries to many patients. One such type of failure is that the implant does not properly adhere to the bone and becomes unattached. Another such failure is that over time metal particles slough off and the debris causes inflammation, tissue damage and extreme pain to an individual. There is also some research that indicates that the cobalt and chromium materials used in these implants can be toxic and may lead to certain cancers, including leukemia.

Of course, this recall comes in the wake of several other recalls by Johnson & Johnson – most notably Tylenol Children's liquid. The president of DePuy Orthopaedics said, “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall.”

If you or anyone you know has been injured by a product such as the DePuy hip implant or any other defective product contact our Valdosta Attorneys for a free consultation about your potential case.