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Mark & Associates, P.C., a law firm dedicated to representing victims of medication side effects, is investigating reports of serious tendon injuries including tendon ruptures and tendonitis in patients taking the antibiotics Cipro / Proquin (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin). These drugs are members of the fluoroquinolone class of antibiotics and are prescribed to treat respiratory infections including bronchitis, sinusitis and pneumonia, certain sexually transmitted diseases such as gonorrhea, ear infections, urinary tract infections, tuberculosis, anthrax infection, infectious diarrhea and other infections throughout the body. Cipro, Levaquin and Avelox users who suffered tendon injuries can receive free case evaluations by visiting the following websites: http://www.CiproTendonRupture.com, http://www.LevaquinTendonRupture.com, http://www.AveloxTendonRupture.com and http://www.AntibioticTendonRupture.com.

Free legal consultations are also available to tendon injury victims via the firm’s toll-free number: 1-866-50-RIGHTS (1-866-507-4448).

Mark & Associates, P.C. applauds the FDA’s July 8 decision to request that fluoroquinolone manufacturers include black box warnings on the drug labels informing patients and healthcare professionals about the risk of tendinitis and tendon rupture. However, the firm believes that the agency’s action comes late for hundreds of tendon injury victims who may suffer pain, restricted movement and permanent disability throughout the remainder of their lives. Many tendon injury victims must undergo surgery and years of physical therapy; many will never fully recover from their injuries.

Bayer A.G.’s Cipro gained FDA approval in 1987 and was widely prescribed during the anthrax scares following the September 11, 2001 attacks, despite the drug’s health risks and the availability of safer antibiotics effective at treating anthrax infection. Levaquin, manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., was approved late in 2004. Avelox, developed by Bayer A.G. and marketed by Schering-Plough Corporation, gained FDA approval late in 2005. Bayer continues to tout the safety and effectiveness of Cipro and Avelox, even as new studies confirm the risk of side effects associated with the drugs.

Patients taking fluoroquinolone antibiotics who experience pain, swelling and inflammation associated with tendon injuries in the Achilles (heel), shoulder, hand, knee or other area are urged to seek immediate medical treatment. Tendon ruptures and tendinitis can occur during treatment with a fluoroquinolone antibiotic or up to several months after completing a course of treatment. Tendon injuries can be preceded by pain or may occur suddenly and without warning symptoms. Patients affected by tendon injuries during or following treatment with Cipro, Levaquin or Avelox are encouraged to contact Mark & Associates, P.C. for a free legal consultation. For more information on Mark & Associates, P.C. please visit http://www.YouHaveRights.com.

About Mark & Associates, P.C.

Mark & Associates, P.C. is a leading products liability and personal injury law firm with offices in Boston, Massachusetts and Long Island, New York. The firm aggressively represents victims of defective pharmaceuticals and medical devices, dangerous consumer products, bad faith insurance denials, toxic exposure and serious auto and common carrier accidents.

CONTACT: Mark & Associates, P.C.
Jason Mark, Esq.
1-866-507-4448
info@youhaverights.com

On July 30, 2008, the FDA ordered modifications to the labels of anemia drugs sold by Amgen Inc. and Johnson & Johnson, restricting their usage in cancer patients.

An FDA advisory committee back in March called for new limits on cancer patients’ use of the blockbuster drugs, known as erythropoiesis-stimulating agents, or ESAs, made by the companies.

The order marks the first time the agency is using authority granted to it in 2007 to force a drug manufacturer to change a drug’s label a move that comes after the agency and Amgen were unable to come to complete an agreement on certain restrictions.

The FDA ordered the new labels to say that the drugs shouldn’t be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated.

It also ordered inclusion of a statement that the drugs aren’t to be administered when hemoglobin levels are greater than or equal to 10 grams per deciliter.

Amgen, of Thousand Oaks, Calif., sells the drugs under the brand names Aranesp and Epogen. Epogen is marketed only for kidney-failure patients on dialysis because Amgen licensed other uses of the drug to Johnson & Johnson, which sells it as Procrit.

Commenting on the order, an Amgen spokesman said, “This label is consistent with our expectations. We will soon be communicating the revised product labeling for ESAs to both physicians and patients.”

Johnson & Johnson, of New Brunswick, N.J., said it will cooperate with the FDA to implement the new label. A spokeswoman also said they are working with the agency on a risk-management plan to “ensure that the medication’s benefit outweighs the risk in this patient population.”

The label changes don’t incorporate all the recommendations of the March committee, which said patients with advanced breast cancer and head-and-neck cancer shouldn’t get the medicines. The drugs already carry strong safety warnings on their labels.

In today’s Big Pharma era it is common for drug manufactures to marketing FDA approved medications for off-label uses. The FDA does not have adequate manpower to combat these blatant acts. Once federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes the agency an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.

Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

Drug companies are forbidden to promote medications for uses that have not been validated by the FDA on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.

The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said in a statement. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Instead, the office that oversees all drug advertising, including television commercials and magazine ads, handles the job. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements.

The office tries to set priorities, by focusing first on misrepresentations that could have a damaging impact on human health. But the report found that the FDA lacks a system for tracking all the material it receives.

From 2003-2007, the office issued 42 notices of possible violations, which usually prompted the drug maker to drop its promotional claims. The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers.

An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify approved to treat schizophrenia and bipolar disorder for treatment of dementia-related psychosis and for use in treating children.