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.”

Diabetes Drug Linked to Bladder Cancer

Actos is a drug that is manufactured by Takeda, a Japanese pharmaceutical company, and prescribed to treat type-2 diabetes. In September 2010, the FDA announced that Actos may be linked to urinary bladder cancer. This announcement was made by the FDA after a ten year epidemiological study revealed an increase in bladder cancer in patients taking Actos. After this study was published, Actos was removed from the market in Germany and France, but not in the U.S.

The FDA has since required Actos’ warning label to be revised to include the risk of urinary bladder cancer as a possible side effect.

Actos is currently marketed as a stand-alone drug or in combination form as Actoplus Met, Acoplus Met XR, and Duetact. Actos was designed to increase the cell’s sensitivity to insulin. It was widely prescribed in the United States as the “preferred medicine” for treating type-2 diabetes.

Unbelievably, there is strong evidence that suggests that Takeda, the Japanese manufacturer of Actos, knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical carcinogenicity studies, which showed an increase in drug-induced tumors in the bladders of rats. Despite these studies, which showed an increased risk of tumors, Takeda marketed and sold Actos without any warning whatsoever of an increased risk of bladder cancer.

In fact, it was only after the FDA required the revision to Actos’ warning label that doctors and patients were made aware of the risk of bladder cancer. Unfortunately, millions of Americans took Actos and were exposed to an increased risk of bladder cancer.

If you or a family member took Actos and have been diagnosed with bladder cancer, our Georgia injury lawyers would like to talk with you about your potential claims against Takeda.

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.

Birth Contol Pill Recalled by Manufacturer

A major pharmaceutical company, Qualitest Pharmaceuticals, has just issued a recall of multiple lots of oral contraceptives. The recall is the result of a major packaging error. The tablets within the birth control package are out of order so that women will not be effectively protected against contraception. Specifically, the “sugar pills” included in the packet during the week that a woman is to have her cycle may be dispensed during the week that a woman may ovulate and become pregnant. This results in a high risk of becoming pregnant and may be the equivalent of not using birth control at all.

The following products are subject to the recall:
• Cyclafem™ 7/7/7
• Cyclafem™ 1/35
• Emoquette™
• Gildess® FE 1.5/30
• Gildess® FE 1/20
• Orsythia™
• Previfem ®
• Tri-Previfem®
Anyone taking these birth control products should begin using another form of contraception immediately and contact their health care provider or pharmacist. Pharmacies have been directed to contact consumers who may have received affected product but this may take some time to do.
The affected lot numbers can be found at the Qualitest Pharmaceuticals web site.

Building Bones or Breaking Bones?

Dangers of Osteoporosis Medications
An advisory panel for the FDA is set to meet this Friday to determine the future for osteoporosis medications. Osteoporosis is a condition in which the bones become thin and weak and break easily. The FDA panel is expected to make recommendations on whether use of osteoporosis frugs should be limited to a few years or whether some women should temporarily stop treatment, a concept known as a drug holiday. It was originally thought that osteoporosis medications could be used indefinitely. However, problems began surfacing in the late 1990's that changed the outlook.

Fosamax (an oral bisphosphonate) is probably the most common medication that has been prescribed to both men and women as a treatment and preventative for osteoporosis. It has also been prescribed to women and men who are taking corticosteroid medications. Most commonly, women take Fosamax during and after menopause.

Fosamax is not the only drug in this class of oral bisphosphonates. The other more common names are Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.  However, in the 16 years since the FDA approved the first oral bisphosphonate, which was Fosamax made by Merck & Co., they have all had numerous problems.

Jaw Bone Danger
The Journal of Oral and Maxillofacial Surgeons reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). ONJ is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of Osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction. Some cases require the complete removal of the affected jaw bone.
The FDA and the manufacturer of Fosamax issued a warning to health care professionals on September 24, 2004 of the danger of ONJ associated with the use of this drug.


Thigh Bone Danger
Unfortunately, Fosamax and other bisphosphonates (which include Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid) did not only cause problems with jaw bones. In October of 2010, all manufacturers of bisphosphonates were required by the FDA to include in the warning section of their label a description of low-energy femoral shaft and subtrochanteric fractures that are associated with the use of drugs in this class.

The FDA reviewed data from an ongoing safety review of oral bisphosphonates and determined that use of the drug was related to an increased risk of thigh fractures. More specifically, it was determined that low-energy femoral shaft and subtrochanteric fractures were occurring in patients who were taking bisphosphonates like Fosamax. This means that people were suffering broken thigh bones without trauma to the leg – literally just walking down the street and all of a sudden the thigh bone would snap and break.


Other Dangers
Bisphosphonate users are also at increased risk of developing stomach ulcers if they are taking this medication with anti-inflammatory drugs. The FDA has also examined a link between these bone building drugs and irregular heartbeats. Physicians have also indicated that these drugs cause musculoskeletal pain including back pain, joint pain, intense muscle spasms and also headaches, numbness in the hands, chest pain & tightness, and persistent dizziness.


Other Bisphosphonates
Among the group of bisphosphonates approved for use in the US are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.


What You Can Do
Because these bone density building drugs and medications can do more harm than good, doctors encourage patients to follow a good diet and do weight-bearing exercise in lieu of taking medications to remedy ailments such as low bone density. Talk with your doctor to determine if there are alternative ways you can build and support your bones without taking these medications.

If you know someone who has had a broken thigh bone (or subtrochanteric fracture), ask them if they are taking Fosamax or any other oral bisphosphonate (like Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid). If so, tell them to contact a pharmaceutical injury lawyer immediately to determine if they have a case.

Paxil & Birth Defects

Paxil is a popular antidepressant which has been on the market since 1992 and is manufactured by GlaxoSmithKline. It is used to treat people with depression, OCD, anxiety, PTSD, and PMDD as well as other similar conditions.

As with almost any anti-depressant, there is a long list of possible side effects associated with taking Paxil. One such potential side effect is birth defects if the drug is taken by a woman during pregnancy. Studies have shown that if Paxil is taken during the first trimester a baby is 1 ½ - 2 times more likely to be born with a heart defect (usually holes in the interior walls of the heart). Other studies have shown that if Paxil is taken any time after the first 20 weeks of pregnancy, a baby may be born with persistent pulmonary hypertension (abnormal blood flow through the heart and lungs and thus insufficient oxygen to their bodies). This condition can lead to multiple organ failure, brain damage, developmental delays, neurological deficits and ultimately death.

For more information on how Paxil can affect a baby if taken during pregnancy, please visit this website or the FDA’s website. Also, please view the GlaxoSmithKline’s September 2005 letter to healthcare professionals on this matter.

If you, your baby or anyone you know has been injured by this or any other pharmaceutical product, contact us for a free consultation about your potential case.

Gardasil marketed towards boys as well as girls

Much controversy has surrounded the use of the new Gardasil vaccination in girls and young women. Now the drug is also being marketed towards boys and young men. Gardasil is a vaccine which aids in the protection against HPV (human papillomavirus), a sexually-transmitted disease which can cause genital warts in both males and females. The drug is administered to individuals between the ages of 9 and 26.

Of course, this drug was only introduced in 2006 and little is known about the long-term effects this drug can cause. Some possible serious side effects that have been experienced recently include:

- Gastroenteritis;
- Appendicitis;
- Pelvic inflammatory disease (PID);
- Asthma or bronchospasms (airway spasms);
- Blood clots in the legs or lungs;
- Seizures; and
- Guillain-Barré syndrome.

There have also been 49 reported deaths connected with the use of Gardasil according to the Centers for Disease Control and Prevention's Vaccine Adverse Event Reporting System.

While Merck insists its products are safe for use by individuals between the ages of 9 and 26, we at the Studstill Firm, LLP encourage you to discuss the risks with your doctor or child’s doctor prior to using this product. If you or anyone you know has been injured by this or any other pharmaceutical product, contact us for a free consultation about your potential case.