Salix Pharmaceuticals

Salix received FDA approval for Metozolv last September, offering an alternative to the metoclopramide pill known by the brand name Reglan. Reglan received a black box warning from the FDA last year after long-term (12 weeks or more) use of Reglan was linked to a serious involuntary movement disorder known as Tardive Dyskinesia.

As another version of metoclopramide, Metozolv is also required to carry the same warning on its label and provide adequate warnings of the serious side effect in its marketing materials. By not doing so, the FDA said, “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

However, the warning did not affect the company’s stock, which rose $1.74 last week to close at $37.41. If Salix does not correct the violations, the company could face FDA regulatory action.

SOURCE: Reglan Side Effects › Salix stock soars despite FDA warning letter

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

The FDA approved Metozolv in September for the treatment of GERD, gastroparesis, and other acid reflux conditions. It is the first fast-dissolving version of metoclopramide, a drug also known by the brand name Reglan. Its projected annual sales could reach $50 million.

Last year the FDA ordered a black box warning be placed on Reglan after numerous reports of a serious involuntary movement disorder known as Tardive Dyskinesia developing in patients who took Reglan. The same black box warning was to be placed on Metozolv when it became available in the U.S. However, upon review, the FDA says Salix fell short of adequately warning patients of the risks associated with Metozolv.

The FDA is ordering Salix to immediately stop the dissemination of the violative promotional materials for Metozolv and to submit a written response to its warning letter explaining how the company will comply with the agency’s request. Failure to correct the violations could result in regulatory action, including seizure or injunction without further notice.

SOURCE: Reglan Side Effects › FDA warns makers of acid reflux drug to change warning label

Side effects of nizatidine include abdominal pain, diarrhea, dizziness, gas, headache, indigestion, inflammation of the nose, nausea, pain, sore throat, vomiting and weakness.

The new generic medication offers another drug choice for patients who suffer from uncomfortable and sometimes painful symptoms of GERD. Another popular prescription drug in the treatment of GERD includes Reglan (metoclopramide). Earlier this year the FDA issued a black box warning on metoclopramide products following reports of an involuntary movement disorder known as Tardive Dyskinesia in patients who took metoclopramide for more than 12 weeks.

People who suffer from Tardive Dyskinesia experience involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

This fall, the FDA approved an orally dissolving tablet form of metoclopramide under the brand name Metozolv ODT. That medication also falls under the same black box warning as other metoclopramide products, such as Reglan. Nizatidine is not the same medication as metoclopramide, and thus does not fall under the same FDA warning.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves generic GERD treatment

The Gastroparesis, etc… blogger was diagnosed with the condition in 2004, and in that time has gathered a great deal of information on treatments for the debilitating condition, which she readily shares on her Web site. Gastroparesis is individualized and a treatment that works for one person may not work for another, she says.

She has tried a long list of treatments from Botox to acupuncture to Reglan, but few have worked well for her. She will receive a gastric neurostimulator, also known as a gastric pacemaker, next week. “It took four months to get the procedure approved by my insurance company, but in that time I gained a great deal of knowledge and collected a plethora of resources which I am anxious to pass along.”

The blogger also passes on to her readers information about new treatments and drug warnings, such as the recent black box warning on metoclopramide, also known by the brand name Reglan, and the newly approved Metozolv ODT, an orally disintegrating version of the same medicine. The black box warning notifies patients and health care workers of an increased risk of a serious movement disorder known as Tardive Dyskinesia associated with long term use of metoclopramide.

Whatever course of treatment sufferers of gastroparesis choose, the blogger offers this advice: “Be your own advocate. Truly, in every way. Do your own research. Try everything for yourself. And never, ever give up!”

SOURCE: Reglan Side Effects › Gastroparesis sufferer urges, Never give up!

Salix Pharmaceuticals, Ltd

Gastroparesis, or delayed emptying of the stomach contents, affects nearly 1.5 million people and can cause pain, bloating, vomiting and malnutrition. GERD, or gastroesophageal reflux disease, affects approximately one-third of the U.S. population. Metozolv ODT is designed for sufferers of both conditions who have difficulty swallowing, need treatment but do not have water available, or need a portable way to take medication. Metozolv ODT rapidly melts on the tongue and gives patients an alternative to the pill form of metoclopramide.

Metozolv ODT will carry the same black box warning as the brand name metoclopramide, Reglan, which warns users that long-term therapy (12 weeks or longer) increases one’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition is disabling and does not usually go away once treatment with metoclopramide has stopped.

Metozolov ODT packaging will also warns users that the drug should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms, and neuroleptic malignant syndrome with a prior history of depression.

Last week, in anticipation of the FDA’s approval, Salix announced that it will increase its sales force by 60 percent to help market Metozolov ODT. The drug has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.

Source: Reuters

SOURCE: Reglan Side Effects › Salix receives FDA approval to market new metoclopramide drug