Proton Pump Inhibitors Birth Defects

Drugs have been linked to bone fractures and birth defects in children, our lawyers and attorneys are seeking people that have been hurt or that have experienced bone fractures from taking certain PPI heartburn medications. We are also seeking women that have taken or had taken PPI drugs before or after getting pregnant and have had a baby with a heart defect or other birth defects.

People who use proton pump inhibitors for 7 or more years to treat reflux, peptic ulcers and other conditions are at greater risk of osteoporosis-related fractures, according to this large observational study of 15,792 patients published in CMAJ.

PPI drugs and Birth Defects:

Conflicting but none less important studies done on PPI drugs have suggested that it is possible that PPI drugs have in fact caused some types of birth defects. The studies haven’t shown when the birth defects have taken place. The studies are looking at taking PPI’s while pregnant, or women who took PPI’s right before becoming pregnant, either way it’s best to err on the side of caution if you are pregnant and taking any one of the many types of PPI drugs currently on the market.

The following heartburn medications are now required by the FDA to carry a new warning on their labels linking the drugs to a heightened risk for fractures.

Some brands of Proton Pump Inhibitors(PPI’s) have been linked to bone fractures of the wrist, leg, hip and spine.

List of PPI drugs are:

• Nexium
• Dexilant
• Prilosec
• Prevacid
• Prevacid otc
• Aciphex
• Protonix
• Vimovo
• Zegerid

NEWS: 2011 FDA PPI Warning:
The Food and Drug Administration has announced that it is notifying health care professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year).

The agency said that low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms.

The agency said that treatment of hypomagnesemia generally requires magnesium supplements. However, in approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued, the FDA said.

According to the FDA Drug Safety Communication study published reported an increased risk of hip fractures with the use of PPI’s.

Following the studies the FDA took action requiring a new warning to advise health care professionals and consumers about the risks of using PPI’s and certain types of bones fractures.

Dr. Joyce Korvick, deputy director for safety in FDA's Division of Gastroenterology Products has made statements on PPIs: "Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,"

"Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition," she said.

The label will advise consumers to use this class of medicines, called proton pump inhibitors (PPIs), carefully, because high doses have been associated with an increased risk of fractures of the hip, wrist and spine, the agency said.

The most common side effects of proton pump inhibitors PPIs are:

• Headache
• Diarrhea
• Constipation
• Abdominal pain
• Nausea
• Rash

It is this acidity that in many people causes irritation in the stomach and duodenum and can lead to indigestion and ulcers. Other gastrointestinal disorders include gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome. The drugs can be prescribed or used on a temporary or long-term basis. Many consumers take them daily.

If you or someone you know has suffered any broken bones from taking any of the heartburn drugs listed above please contact us today as there may be a class action lawsuit taking place for these PPIs.