Wednesday, September 21, 2011

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.

Monday, September 12, 2011

Medical Information on Georgia Drivers Licenses

Georgia drivers with certain medical conditions can now choose to have their conditions listed on the back of their Georgia driver's license or state identification card. The Georgia Department of Driver Services now has 16 conditions which may be included on the license, including pacemaker, autism, hearing loss, seizures, brain injury, and diabetes. Other conditions could be added in the future according to Susan Sports, a spokeswoman with the state agency.

Having the information on a driver's license could aid emergency responders in knowing how to best treat people who may be unconscious, advocates say. The information could help law officers determine whether a medical condition, such as a brain injury, may be affecting treatment or behavior.

The information may also be especially helpful for people with hearing loss who are unable to hear instructions or communicate well with law enforcement.

The decision to give motorists the option of having the information was prompted by a state Senate bill signed into law last year that allows people with post-traumatic stress disorder to put a notation on their licenses. "It could make the difference in saving a life," said state Sen. Ronald Ramsey, D-Decatur.

Participation in the new program is voluntary. Forms are available online that need to be filled out by the applicant and submitted at the time of obtaining a license or ID card. For some (non-obvious) conditions, verification from a doctor will also be required.

Wednesday, September 7, 2011

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.