Drug Injury blog

Study researchers and colleagues say Fosamax and other bisphosphonate drugs may be riskier than previously thought.

After having teeth pulled, 4% of patients in a study who were taking Fosamax developed a dangerous condition called osteonecrosis of the jaw. None of the tooth extraction patients not taking Fosamax developed osteonecrosis.

Osteonecrosis of the jaw, sometimes called jawbone death, occurs when bone in the jaw fails to heal after a minor trauma. It results in pain, swelling, infection, and exposed bone.

In addition to Fosamax, other oral bisphosphonate drugs include Zometa, Aredia, and Actonel, and Boniva.

Merck, who makes Fosamax, is disputing the study.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has issued a voluntary recall of Duragesic CII patches sold by their PriCara division. They are also recalling one lot of patches sold by Sandoz Inc.

The patches may have a cut along one side of the drug reservoir, possibly leaking fentanyl gel, exposing patients or caregivers directly to fentanyl gel.

The patches are both 50 mcg/hr Schedule II opioid medications prescribed to patients for whom other pain therapies have not worked.

Exposure to fentanyl gel may lead to respiratory depression and possible overdose, which may be fatal.

Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only. Do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine’s ability to go through the skin.

Also, immediately dispose of patches with cut edges by flushing them down the toilet, using caution not to handle them directly.

A Food and Drug Administration (FDA) official has reported that Merck’s popular osteoporosis drug Fosamax and other similar drugs may carry a risk for esophageal cancer.

Since Fosamax, known generically as alendronate, was introduced in 1995, the FDA has received 23 reports in which patients developed esophageal tumors. There are 21 additional cases in Europe and Japan.

The drugs aim to treat bone-weakening osteoporosis by increasing bone mass. Patients are instructed to remain upright for at least a half hour after taking them to decrease the risk of esophagitis, an already known side effect of the drug.

Fosamax is a bisphosphonate drug. Similar medications include Actonel, Didronel, and Boniva.

Typically, two years lapse between the start of the drug and the development of esophageal cancer. Eight patients have died in the US, and six in Europe and Japan.

Biovail Corp. has issued a voluntary recall on certain lots of its chronic pain medication Ultram.

According to Reuters, the lots of Ultram were out-of-specification by about one percent with respect to maximum dissolution at the eight-hour mark, according to a report from Reuters.

Biovail, the leading Canadian drug maker, said the voluntary recall will cost the company at least $4.4 million in revenue.

Ultram is primarily used to treat chronic pain in adults.

The company said the product defect, the reason for the recall, does not affect patient safety.

The Federal Health and Ageing Department in Australia have revealed that use of a cosmetic treatment has resulted in birth defects.

The mother was given Dysport in her first week of pregnancy.

The baby was born deaf and blind.

Dysport, Myobloc and Botox are botulinum type A toxin drugs used as cosmetic treatments.

U.S. Food and Drug Administration notified the public that the most common side effects of the drugs are temporary facial paralysis, visual disturbances, fatigue, dizziness, difficulty swallowing, hallucinations, anxiety, respiratory failure, and death.

The Food and Drug Administration has approved the gadolinium-based Vasovist injection for use in patients about to undergo a magnetic resonance angiography, which scans blood vessels.

The active ingredient in Vasovist is gadolinium, a metal mined from the earth, making this a gadolinium contrast agent. The FDA said it looked at the drug in two clinical trials.

When injected, the gadolinium provides vivid contrast allowing radiologists to provide more accurate readings from the MRA scans.

However, gadolinium contrast agents have been linked to a fatal disease known as nephrogenic systemic fibrosis, which causes a painful tightening and drying of the skin until eventually the patient is unable to move.

The disease is likely to strike patients who receive a gadolinium contrast agent who present a kidney dysfunction, disease or cancer. Dysfunctional kidneys do not allow the body to flush the gadolinium properly, storing it in the body.

Based on its public warning issued in 2007, warnings about NSF are included in every product which has gadolinium as its active ingredient.

Because NSF is an obscure disease, coupled with the demand for magnetic scans with contrast agents, patients may not be aware of the possible side effect. Physicians, however, should be aware of this disease and keep it in mind when scheduling scans with contrast agents.

Despite these dangers, the FDA stands behind its decision to approve Vasovist.

Federal regulators have agreed to a Consent Decree with Icelandic drugmaker Actavis in which the company will temporarily cease production of generic drugs at its New Jersey manufacturing plants.

The U.S. Justice Department filed a complaint against the company last month for not complying with Food & Drug Administration (FDA) good manufacturing standards.

Actavis announced a voluntary recall of products made at its Little Falls plant in August. That followed an April recall of Digitek tablets, some of which were made there.

Actavis says it expects to resume manufacturing once it comes back into FDA compliance.

A Harvard researcher says he’s fighting to clear his name in a conflict-of-interest dispute with the maker of an anti-aging supplement.

Shaklee, makers of the anti-aging supplement Vivix, say they had every right to use the name of Harvard University professor David Sinclair to endorse their product. Sinclair denies this deal was ever in place.

The Wall Street Journal has a video on its Web site showing Sinclair addressing Shaklee salespeople, touting the alleged benefits of the active ingredient in Vivix, a compound called resveratrol.

Sinclair’s research for Shaklee, came via his work with Sirtris, a company working on resveratrol research, which was eventually sold out to GlaxoSmithKline. That transaction netted Sinclair at least $8 million and he remains a consultant.

Sinclair’s case is one of the latest in which a researcher’s financial ties call into question his or her ability to remain objective.

Many supplements which can escape Food and Drug Administration approvals and can be sold online and in stores contain dangerous chemicals and drugs not approved for their intended use in the supplement or drug.

Physicians and professors are offered top dollar by the makers of these products so their product can gain some credibility.

Nearly one in 25 older Americans are at risk for serious health problems such as bleeding and muscle weakness because they take an unwise combination of drugs.

Half the time, a non-prescription medication is involved.

The most commonly used prescription or over-the-counter medications were taken to treat heart disease and range from aspirin to blood thinners to statins.

The most common supplements were single vitamins, multivitamins and minerals, as well as omega-3 fatty acids, glucosamine-chondroitin, garlic, and “eye vitamins” for macular degeneration.

The findings have potential implications for the Food & Drug Administration, policymakers, physicians, pharmacists and patients.

Federal regulators warned Abbott Laboratories over an advertisement for the psoriasis drug Humira, saying it is misleading and makes claims not supported by scientific evidence.

The ad for Humira suggests the drug is approved for any patient with moderate to severe chronic plaque psoriasis. Humira is only approved for a more limited patient population.

The ad presents risks associated with Humira in “extremely” small type that fails to adequately convey the serious risks connected to the product. Humira carries a black-box warning that details risks, some fatal.

The FDA has told Abbott to cease use of the ad and to respond by Jan. 2 with details about whether it intends to comply with the request.