Sotto the legislator

Sen. Vicente Sotto III need not redeem himself.

It may be said that Sotto handily won a Senate seat in the May 10 polls on the strength of his popularity as a showbiz celebrity. But that is politics—Philippine style. Sotto, Senate Majority Floor Leader of the 15th Congress, deserves none of the harsh criticisms being thrown his way. While more known as a showbiz personality, Sotto is not exactly a stranger to legislation or to politics for that matter.

His grandfather and granduncle were former senators. He became Quezon City vice mayor,

He is the grandson and namesake of former Sen. Vicente Y. Sotto of Cebu and grandnephew of then Sen. Felimon Sotto, was vice mayor of Quezon City from 1988 to 1992 during which he made the anti-drug campaign his top priority, was named vice chair of the Citizens Drugwatch and was instrumental in forming the Vice Mayors League of the Philippines.

In 1992, he became Senator by garnering more than 11 million votes, was reelected in 1998, and was assistant majority floor leader in the 11th Congress, and minority floor leader in the 12th Congress.

In 2008, Sotto was made chair of the Dangerous Drugs Board where he formulated policies for a more effective implementation of the Comprehensive Dangerous Drugs Act of 2002.

Presently, Sotto is back at the Senate—another remarkable achievement considering that he ran as lone senatorial bet of the Nacionalista Party.

The senator showed that friendship and kinship end where commitment and loyalty to party mates begin when he refused to back Sen. Kiko Pangilinan’s bid to be Senate President.

As a senator, Sotto authored a total of 103 bills, some of which were considered landmark legislations. Among them are RA 9165 creating the Philippine Drug Enforcement Agency, RA 8369 setting up Family Courts nationwide, RA 9189 (Absentee Voting), RA 8545 institutionalizing the Teachers and Students Government Assistance, RA 8750 (Seatbelt Law), and RA 8185 (Judicious use of calamity funds).

Bayer reacts

Dr. Luis Abola, medical director of Bayer HealthCare, which manufactures the over-the-counter and much publicized drug Saridon, recently e-mailed his response to some questions that have been raised about the possible dangers of the said analgesic product.

In 1983, the US Food and Drug Administration ordered the pull-out of Saridon from the market because of the side-effects of a major ingredient phenacetin, Lab rats were tested with phenacetin and found them to have been cancerous. Phenacetin is also widely known to be a cocaine extender.

Abola explains that Saridon was reformulated in 1981 and phenacetin was replaced with paracetamol. It also now contains propyphenazone, which together with paracetamol and caffeine are the ingredients of the reformulated Saridon Triple Action.

Abola corrected us by saying that propyphenazone is not a derivative of phenacetin. It is paracetamol an active metabolite of phenacetin.

Lareb, a Dutch Pharmacovigilance Center, has reported “a concerning reporting rate of anaphylactic reactions after use of Saridon. Up to June 8, 2004, a total of 20 adverse reactions to Saridon have been reported to Lareb, which interpreted 16 of these reports to be allergic reactions. Of the 16, 10 are reported as anaphylactic reactions.”

The Lareb report also mentioned Meyler as stating that severe hypersensitivity reactions to propyphenazone have been reported.

“There is no information available of the incidence of anaphylactic reactions to propyphenazone, there are only few case reports in literature. The SPC states an incidence of less than 0.01 percent. However, the high fraction of reports with an allergic reaction on Saridon and comparable drugs in the Lareb database, suggests the actual incidence to be higher. This leads to concern, since Saridon is available as OTC medication,” it concluded.

In his e-mail, Abola emphasized that while the Lareb report did mention propyphenazone as having anaphylaxis reaction or allergic reaction, there was mention of 10 fatal or near fatal cases.

What is analphylaxis? Wikipedia defines it as an acute multi-system severe type I hypersensitivity reaction. Anaphylaxis results in approximately 1,500 deaths per year in the US.

Anaphylaxis is a severe, whole-body allergic reaction. After an initial exposure “sensitizing dose” to a substance like bee sting toxin, the person’s immune system becomes sensitized to that allergen. On a subsequent exposure “shocking dose”, an allergic reaction occurs. This reaction is sudden, severe, and involves the whole body.

WebMB says anaphylaxis is a sudden, severe allergic reaction that occurs when you are exposed to a substance that your body was sensitized to during a previous exposure.

“The life-threatening reaction causes a sudden release of chemicals, including histamines, from cells in the blood and the body’s tissues. These chemicals dilate the blood vessels, lowering blood pressure, and they cause the blood vessels to leak fluid, leading to hives and swelling, especially around the face and throat. The chemicals also act on the lungs, causing an asthmatic reaction — that is, causing the lung’s airways to constrict, thus making breathing very difficult. In some cases, anaphylaxis may have mild symptoms, causing only hives and itching. But it can be deadly. Blood pressure can drop severely, leading to loss of consciousness. Swelling of the throat and airways can cause difficulty breathing, speaking, and swallowing. Anaphylaxis is a medical emergency,” it added.

I know I’m not a doctor. But it sounds fatal to me.

Abola notes that according to the Lareb report, there are 20 reported adverse event cases for Saridon, and 114 for paracetamol. “Clearly, the 20 reports on Saridon was grossly magnified and taken out of context,” he said.

Didn’t the good doctor just say the reformulated Saridon now contains paracetamol?

He also mentioned that “a report by Van der Klauw on a 20-year report on drug-associated anaphylaxis shows that while prophyphenazone was reported to have probably/possibly caused anaphylaxis, other drugs such as Ibuprofen, Naproxen, Diclofenac are also in the list of possible causes.”

Again, prophyphenazone, an ingredient of the reformulated Saridon, is mentioned as possibly causing anaphylaxis.

Abola quotes a study by Kiersch and Minic which states that adverse events were experienced by only 3.4 percent of those taking Saridon, lower than the 9.72 percent of those taking paracetamol.

Now I’m confused. If Saridon contains paracetamol and propyphenazone, should we now be doubly concerned?

He also stated that in their most recent Periodic Update Safety Reporting covering the period of Nov. 2008-Nov. 2009, which was generated by their global pharmacovigilance and submitted to health authorities, there were no case reports on fatal outcomes.

But he added that “approximately 25.8 million patients worldwide were treated during this period. Nine new medically confirmed case reports were received of which eight were serious and one was non-serious. 25 non-medically confirmed reports were also received including five serious reports.  Considering the approximate number of worldwide users, this incidence is extremely low.  There were no case reports on fatal outcomes received. Since the start of marketing in 1981, only 173 medically confirmed case reports on Saridon have been received.”

Ok. Ok. Nobody died. But some were serious? Should we be happy with that?

Abola however failed to explain why Saridon Triple Action is being sold only in Visayas and Mindanao and not in Metro Manila? Is this a case of a possibly dangerous drug being market-tested in areas far from our FDA’s watchful eyes?

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