Legal Information and Resources

On September 26, 2011, the FDA issued a notice that it was concerned about birth control pills with drospirenone and certain doses of estrogen causing blood clots. Yaz/Yasmin/Ocella are in this group. The preliminary results looked at by the FDA from an FDA-funded study showed women using those drugs face a 1 ½ times greater risk of blood clots than women using prior birth control pills. (more…)

The FDA Advisory Panel which met on September 9, 2011 called for changes in the warnings on Fosamax and other bisphosphonate drugs. The 17-6 vote, after four years of evaluation, may result in the FDA directing Merck and other companies to revise their labels. (more…)

On September 9, 2011, an Advisory Committee of the FDA studying drug safety will meet to conduct a review of bisphosphonates. These drugs include Fosamax, which was approved in 1995 and prescribed for osteoporosis and Paget’s disease of the bone. Some doctors have prescribed it for osteopenia. Studies have linked Fosamax with osteonecrosis of the jaw (ONJ) and femur (thigh bone) fractures. The FDA is considering “drug holidays” because of the risks of long-term use. Merck sells Fosamax and it will make a presentation to the Advisory Committee. Partner, Jim Pettit, is handling the firm’s Fosamax cases, and is filing them in Atlantic City, New Jersey. Mass Tort Judge Carol Higbee is managing all the Fosamax cases in the state.

On May 31, 2011, the FDA announced that it is reviewing two recent articles in the British Medical Journal on the issue of whether the progestin DROSPIRENONE (a component of YAZ, YASMIN, OCELLA and other birth control drugs) increases the risk of DVT (deep vein thrombosis) and of PE (pulmonary embolism). (more…)

US and European regulators, in a highly unusual coordinated move have determined a course of action concerning Glaxo-Smith Kline’s diabetes drug Avandia, which was shown to be associated with an increased risk of heart attacks and stroke after Dr. Steven Nissen of the Cleveland Clinic performed an independent analysis of GSK’s own studies. European authorities will suspend the use of the drug and the FDA will severely restrict the use of the medication in the United States.

The New York Times reports today that the embattled diabetes drug will only be available to patients and their doctors in the US who attest that the drug is the last line of defense—that all other diabetes drugs have been tried in a patient without satisfactory results. Additionally, both patients and doctors will have to assert that the patient has been warned about the possible life-threatening side effects of Avandia.

GSK has been under fire for years as a result of its aggressive Avandia marketing efforts. After internal company documents were made public that revealed GSK’s efforts to hid negative test results, and a legal settlement which forced GSK to post drug study information on a website, Dr. Steven Nissen form the Cleveland Clinic performed an independent study that highlighted the cardiac dangers of the drug. FDA’s decision here highlights a new government tack that indicates Big Pharma may be under greater scrutiny in the coming years.

The Avandia news continues. Just last month, there was a meeting of a joint advisory committee reporting to the Food and Drug Administration (FDA) concerning the potential health risks of the diabetes drug Avandia. This was the second meeting of this committee. It originally met in July of 2007 and reported that Avandia was associated with an increased risk of heart attacks. Three years have now passed, and the committee has met again, and this time, although 12 members of the committee voted to withdraw Avandia from the marketplace, 21 members voted that it remain available for sale and use. (more…)

The hits just keep coming for drug giant J&J who recently issued recalls for some its most popular and profitable products like Children’s Tylenol, and just last week, its Acuvue contact lenses had to be pulled from the Asian and European markets. Yesterday, J&J’s DePuy Orthopedic division recalled the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. (more…)

The good news keeps coming for Glaxo, the pharma giant that makes the diabetes drug Avandia. Yesterday the FDA ordered Glaxo to stop patient enrollment in a study that compared Avandia to a competing drug Actos, and to warn all patients already enrolled that Avandia may increase the risk of heart attacks.

Dr. Steven Nissen, whose 2007 study sounded the alarm about Avandia, was quoted in the New York Times today as saying he believed that the Panel’s findings about Avandia would eventually lead to suspension and abandonment of the study altogether. Nissen noted: “There was really no other action they [FDA] could take. Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”

Stay tuned.
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As a follow-up to my blog post of July 16, 1010, the Wall Street Journal today reports that an FDA panelist who voted to leave Glaxo’s diabetes drug Avandia on the US market with no additional restrictions received—wait for it folks—money from the drug maker for being a member of its “speakers bureau.” Philadelphia based endocrinologist David Capuzzi, M.D. told the WSJ that since he never gave talks “promoting” Avandia, he didn’t see any conflict of interest. Dr. Capuzzi was only one of three members of the 33 member panel who voted to leave Avandia on the market without further restrictions. (more…)

Readers of beauty magazines are familiar with the articles and advertisements that feature physicians touting the “magical results” that come from using various products to correct conditions ranging from cellulite to droopy underarm skin, from yellow teeth to wrinkles. In response to escalating complaints from consumers, the FDA has launched a new effort to rein in the more extravagant claims—especially when the claims involve doctor-pitchmen or pitch-women, and the products are drugs.

The New York Times today reports that in a shot across the beauty and the doctor medical bow, FDA has issued a warning to a well known dermatologist and clinical researcher in Miami Beach alleging that she improperly advocated the use of an as yet unapproved drug she promoted for the “treatment” of wrinkles. Dr. Leslie Baumann was issued a warning letter advising the doctor that she engaged in promotion of an unapproved drug, which is a violation of FDA policy. Unfortunately, Dr. Baumann is rather the rule than the exception in an industry where media exposure is critical for both the sales of such products and to expand the clientele of the doctors that use them.